AzTrials
AzTrials

AsthmaPhase 3NCT02571777

Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

A Phase 3 study testing QVM149 150/50/160, QVM149 150/50/80 and QMF149 150/320 in people with Asthma, run by Novartis Pharmaceuticals at 403 sites in 41 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
QVM149 150/50/160, QVM149 150/50/80 and QMF149 150/320
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,092 participants
Where
403 sitesin 41 countries
Study dates
8 Dec 2015to 14 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of asthma, (GINA 2015) for a period of at least 1 year prior to Visit 1 (Screening).
  • Patients who have used medium or high dose of ICS/LABA combinations for asthma for at least 3 months and at stable medium or high doses of ICS/LABA for at least 1 month prior to Visit 1.
  • Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS/LABA. Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (before randomization).
  • Patients with documented history of at least one asthma exacerbation which required medical care from a physician, ER visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1, and required systemic corticosteroid treatment.
  • Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient according to ATS/ERS guidelines after withholding bronchodilators at both visits 101 and 102.
  • Withholding period of bronchodilators prior to spirometry: SABA for ≥ 6 hrs, Twice daily LABA (or FDC of ICS/LABA) for ≥ 12 hrs, Once daily LABA (or FDC of ICS/LABA) for ≥ 24 hrs, SAMA for ≥ 8 hrs, Short acting xanthines for 12 hrs, Long acting xanthines for 24 hrs, .
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  • Washout period of each drug should be kept as close as possible as above and should not be longer. If longer washout period is needed due to scheduling issues, please contact Novartis Medical monitor.
  • A one-time repeat of percentage predicated FEV1 (Pre-bronchodilator) at Visit 101 and/or Visit 102 is allowed in an ad-hoc visit. Repeat of Visit 101 spirometry should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before randomization. Run-in medication should be dispensed once spirometry assessment met inclusion criteria (ATS/ERS quality criteria, FEV1 % predicted normal value, and reversibility) as per equipment
  • A one-time rescreen is allowed in case the patient fails to meet the criteria at the repeat, provided the patient returned to the required treatment as per inclusion criteria 4
  • Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101.All patients must perform a reversibility test at Visit 101. If reversibility is not demonstrated at Visit 101 then one of the following criteria need to be met.
  • Reversibility should be repeated once.
  • Patients may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1.
  • Alternatively, patients may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1. If reversibility is not demonstrated at Visit 101 (or after repeated assessment in an ad-hoc visit) and historical evidence of reversibility/bronchoprovocation is not available (or was not performed according to the ATS/ERS guidelines patients must be screen failed
  • Spacer devices are permitted during reversibility testing only. The Investigator or delegate may decide whether or not to use a spacer for the reversibility testing

Who cannot join

  • Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). If patients experience an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation.
  • Patients who have ever required intubation for a severe asthma attack/exacerbation.
  • Patients who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study.
  • Patients treated with a LAMA for asthma within 3 months prior Visit 1 (Screening).
  • Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients who are stable on treatment can be considered).
  • Patients who have had a respiratory tract infection or asthma worsening as determined by investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
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  • Patients with evidence upon visual inspection (laboratory culture is not required) of clinically significant (in the opinion of investigator) oropharyngeal candidiasis at Visit 102 or earlier, with or without treatment. Patients may be re-screened once their candidiasis has been treated and has resolved.
  • Patients with any chronic conditions affecting the upper respiratory tract (e.g. chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
  • Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
  • Patients with Type I diabetes or uncontrolled Type II diabetes.
  • Patients who, either in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition such as (but not limited to) unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease, psychiatric disease, neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state, or ophthalmologic disorder or patients with a medical condition that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
  • Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blockers, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at the run-in visit (Visit 101) with a resting ventricular rate < 100/min. At Visit 101 the atrial fibrillation must be confirmed by central reading.
  • Patients with a history of myocardial infarction (this should be confirmed clinically by the investigator) within the previous 12 months.
  • Concomitant use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study
  • Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (> 450 msec for males and > 460 msec for females) and confirmed by a central assessor (these patients should not be rescreened).
  • Patients with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
  • Patients who have not achieved an acceptable spirometry result at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability. A one-time repeat spirometry is allowed in an ad-hoc visit scheduled as close as possible from the first attempt (but not on the same day) if the spirometry did not qualify due to ATS/ERS criteria at Visit 101 and/or Visit 102. If the patient fails the repeat assessment, the patient may be rescreened once, provided the patient returns to the required treatment as per inclusion criteria 4.
  • Patients unable to use the Concept1 dry powder inhaler, Accuhaler or a metered dose inhaler. Spacer devices are not permitted.
  • History of alcohol or other substance abuse.
  • Patients with a known history of non-compliance to medication or who were unable or unwilling to complete a patient diary or who are unable or unwilling to use Electronic Peak Flow with e-diary device.
  • Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).

Trial locations and contacts

403 sites in 41 countries.

403 sites in 41 countries

Russia41 sites

  • Novartis Investigative Site

    Barnaul, 656024

  • Novartis Investigative Site

    Barnaul, 656045

  • Novartis Investigative Site

    Barnaul, 656050

  • Novartis Investigative Site

    Chelyabinsk, 454021

  • Novartis Investigative Site

    Ivanovo, 153005

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    Kemerovo, 650002

  • Novartis Investigative Site

    Moscow, 105077

  • Novartis Investigative Site

    Moscow, 121309

  • Novartis Investigative Site

    Moscow, 125993

  • Novartis Investigative Site

    Nizhny Novgorod, 603011

  • Novartis Investigative Site

    Nizhny Novgorod, 603018

  • Novartis Investigative Site

    Novosibirsk, 630099

  • Novartis Investigative Site

    Novosibirsk, 630102

  • Novartis Investigative Site

    Omsk, 644112

  • Novartis Investigative Site

    Perm, 614056

  • Novartis Investigative Site

    Perm, 614068

  • Novartis Investigative Site

    Pskov, 180007

  • Novartis Investigative Site

    Pyatigorsk, 357500

  • Novartis Investigative Site

    Saint Petersburg, 191015

  • Novartis Investigative Site

    Saint Petersburg, 191123

  • Novartis Investigative Site

    Saint Petersburg, 191186

  • Novartis Investigative Site

    Saint Petersburg, 193231

  • Novartis Investigative Site

    Saint Petersburg, 194354

  • Novartis Investigative Site

    Saint Petersburg, 196143

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 199106

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Sestroretsk, 197706

  • Novartis Investigative Site

    Smolensk, 197022

  • Novartis Investigative Site

    Smolensk, 214006

  • Novartis Investigative Site

    Smolensk, 214019

  • Novartis Investigative Site

    Tomsk, 634063

  • Novartis Investigative Site

    Tver', 170036

  • Novartis Investigative Site

    Ufa, 450000

  • Novartis Investigative Site

    Ulyanovsk, Russian Federation, 432063

  • Novartis Investigative Site

    Vladikavkaz, 362019

  • Novartis Investigative Site

    Volgograd, 400120

  • Novartis Investigative Site

    Vsevolozhsk, 188640

  • Novartis Investigative Site

    Yaroslavl, 150002

  • Novartis Investigative Site

    Yaroslavl, 150003

Other trials in Russia

India35 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 060

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380016

  • Novartis Investigative Site

    Bangalore, Karnataka, 560060

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003

  • Novartis Investigative Site

    Cherthala, Kerala, 688524

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 045

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001

  • Novartis Investigative Site

    Delhi, National Capital Territory of Delhi, 110063

  • Novartis Investigative Site

    Guntur, Andhra Pradesh, 522 001

  • Novartis Investigative Site

    Gurgaon, Haryana, 122 002

  • Novartis Investigative Site

    Hubli, Karnataka, 580022

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500 058

  • Novartis Investigative Site

    Hyderabad, Telangana, 500 038

  • Novartis Investigative Site

    Hyderabad, Telangana, 500004

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302013

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302020

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302023

  • Novartis Investigative Site

    Kanpur, Uttar Pradesh, 208 002

  • Novartis Investigative Site

    Kochi, Kerala, 683 594

  • Novartis Investigative Site

    Kolkata, West Bengal, 700 107

  • Novartis Investigative Site

    Kozhikode, Kerala, 673008

  • Novartis Investigative Site

    Mangalore, Karnataka, 575001

  • Novartis Investigative Site

    Mohali, Punjab, 160 062

  • Novartis Investigative Site

    Mumbai, Maharashtra, 401107

  • Novartis Investigative Site

    Mysore, Karnataka, 570001

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440010

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440019

  • Novartis Investigative Site

    Nashik, Maharashtra, 422007

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110 060

  • Novartis Investigative Site

    Patna, Bihar, 800014

  • Novartis Investigative Site

    Pune, Maharashtra, 411007

  • Novartis Investigative Site

    Pune, Maharashtra, 411014

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632 004

  • Novartis Investigative Site

    Vijayawada, Andhra Pradesh, 520008

  • Novartis Investigative Site

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Germany33 sites

  • Novartis Investigative Site

    Annaberg-Buchholz, 09456

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Berlin, 10119

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 10717

  • Novartis Investigative Site

    Berlin, 12159

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 13057

  • Novartis Investigative Site

    Berlin, 13156

  • Novartis Investigative Site

    Bochum, North Rhine-Westphalia, D-44787

  • Novartis Investigative Site

    Bonn, 53119

  • Novartis Investigative Site

    Cottbus, Saxony, 03050

  • Novartis Investigative Site

    Darmstadt, 64283

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Frankfurt am Main, 60313

  • Novartis Investigative Site

    Geesthacht, Schleswig-Holstein, 12502

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Hamburg, 22299

  • Novartis Investigative Site

    Hamburg, 22335

  • Novartis Investigative Site

    Hanover, 30173

  • Novartis Investigative Site

    Karlsruhe, 76137

  • Novartis Investigative Site

    Koblenz, North Rhine-Westphalia, 56068

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Leipzig, 04357

  • Novartis Investigative Site

    Lübeck, 23558

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mittweida, 09648

  • Novartis Investigative Site

    Neu-Isenburg, 63263

  • Novartis Investigative Site

    Potsdam, 14467

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Witten, 58452

Other trials in Germany

Argentina32 sites

  • Novartis Investigative Site

    Bahía Blanca, Buenos Aires, 8000

  • Novartis Investigative Site

    Buenos Aires, B1646EBJ

  • Novartis Investigative Site

    Buenos Aires, B1842DID

  • Novartis Investigative Site

    Buenos Aires, C1120AAC

  • Novartis Investigative Site

    Buenos Aires, C1125ABE

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABJ

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF

  • Novartis Investigative Site

    Concepción del Uruguay, Entre Ríos Province, 3260

  • Novartis Investigative Site

    Córdoba, 5000

  • Novartis Investigative Site

    Córdoba, X5003DCE

  • Novartis Investigative Site

    Florida, Buenos Aires, B1602DQD

  • Novartis Investigative Site

    Godoy Cruz, Mendoza Province, M5500EOB

  • Novartis Investigative Site

    Lanus, Buenos Aires, B8000XAV

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, B7600FZN

  • Novartis Investigative Site

    Mendoza, 5500

  • Novartis Investigative Site

    Mendoza, M5500CBA

  • Novartis Investigative Site

    Nueve de Julio, Buenos Aires, B6500EZL

  • Novartis Investigative Site

    Paraná, 3100

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSV

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000JKR

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000QID

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Novartis Investigative Site

    San Nicolás de los Arroyos, Buenos Aires, B2900JUB

  • Novartis Investigative Site

    Santa Fe, Rosario, S2000DBS

  • Novartis Investigative Site

    Santa Fe, S3000FIL

  • Novartis Investigative Site

    Santa Fe, S3000FWO

  • Novartis Investigative Site

    Vicente López, Buenos Aires, B1602DOH

  • Novartis Investigative Site

    Villa María, Córdoba Province, X5900JKA

Other trials in Argentina

Japan23 sites

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-0031

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 431-3192

  • Novartis Investigative Site

    Himeji, Hyōgo, 672-8064

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 173-8610

  • Novartis Investigative Site

    Kasuga, Fukuoka, 816-0813

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 215-0021

  • Novartis Investigative Site

    Kishiwada, Osaka, 596-8501

  • Novartis Investigative Site

    Kokubunji, Tokyo, 185-0014

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 712-8064

  • Novartis Investigative Site

    Naka-gun, Ibaraki, 319-1113

  • Novartis Investigative Site

    Obihiro, Hokkaido, 080-0013

  • Novartis Investigative Site

    Okayama, Okayama-ken, 702-8055

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 145 0063

  • Novartis Investigative Site

    Sendai, Miyagi, 980-0871

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo, 142-8666

  • Novartis Investigative Site

    Tokyo, Shibuya Ku, 150 0013

  • Novartis Investigative Site

    Tomakomai, Hokkaido, 053-8506

  • Novartis Investigative Site

    Toshima Ku, Tokyo, 170 0003

  • Novartis Investigative Site

    Yokkaichi, Mie-ken, 510-8561

  • Novartis Investigative Site

    Yokohama, Kanagawa, 223-0059

  • Novartis Investigative Site

    Yokohama, Kanagawa, 231-8682

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232-0064

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236 0051

Other trials in Japan

Hungary17 sites

  • Novartis Investigative Site

    Balassagyarmat, 2660

  • Novartis Investigative Site

    Budaörs, HUN, 2040

  • Novartis Investigative Site

    Budapest, HUN, 1204

  • Novartis Investigative Site

    Budapest, 1106

  • Novartis Investigative Site

    Eger, HUN, 3300

  • Novartis Investigative Site

    Gödöllő, 2100

  • Novartis Investigative Site

    Kapuvár, HUN, 9330

  • Novartis Investigative Site

    Komárom, 2900

  • Novartis Investigative Site

    Mátészalka, 4700

  • Novartis Investigative Site

    Nyíregyháza, H-4400

  • Novartis Investigative Site

    Püspökladány, HUN, 4150

  • Novartis Investigative Site

    Szarvas, 5540

  • Novartis Investigative Site

    Szeged, 6722

  • Novartis Investigative Site

    Szeged, 6772

  • Novartis Investigative Site

    Szigetszentmiklós, H-2310

  • Novartis Investigative Site

    Szigetvár, 7900

  • Novartis Investigative Site

    Tata, HUN, 2890

Other trials in Hungary

Romania15 sites

  • Novartis Investigative Site

    Arad, 310085

  • Novartis Investigative Site

    Bacau, 600252

  • Novartis Investigative Site

    Brasov, 500086

  • Novartis Investigative Site

    Brasov, 500283

  • Novartis Investigative Site

    Bucharest, 030317

  • Novartis Investigative Site

    Bucharest, 050159

  • Novartis Investigative Site

    Cluj-Napoca, 400139

  • Novartis Investigative Site

    Cluj-Napoca, 400162

  • Novartis Investigative Site

    Cluj-Napoca, 400371

  • Novartis Investigative Site

    Constanța, 900591

  • Novartis Investigative Site

    Craiova, ROM, 200712

  • Novartis Investigative Site

    Deva, ROM, 330084

  • Novartis Investigative Site

    Deva, 330162

  • Novartis Investigative Site

    Piteşti, 110084

  • Novartis Investigative Site

    Timișoara, Timiș County, 300310

Other trials in Romania

China13 sites

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Chongqing, 400037

  • Novartis Investigative Site

    Haikou, Hainan, 570311

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200032

  • Novartis Investigative Site

    Shanghai, 200433

  • Novartis Investigative Site

    Shenyang, Liaoning, 110000

  • Novartis Investigative Site

    Shenyang, Liaoning, 110003

  • Novartis Investigative Site

    Shenyang, Liaoning, 110011

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215006

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Xian, Shanxi, 710061

Other trials in China

Poland13 sites

  • Novartis Investigative Site

    Aleksandrow Odzki, Poland, 95-070

  • Novartis Investigative Site

    Bielsko-Biala, 43-300

  • Novartis Investigative Site

    Elblag, 82-300

  • Novartis Investigative Site

    Inowrocław, 88-100

  • Novartis Investigative Site

    Krakow, 30033

  • Novartis Investigative Site

    Krakow, 31159

  • Novartis Investigative Site

    Ksawerów, POL, 95-054

  • Novartis Investigative Site

    Lodz, 90-302

  • Novartis Investigative Site

    Ostrów Wielkopolski, 63-400

  • Novartis Investigative Site

    Sopot, 81-741

  • Novartis Investigative Site

    Wejherowo, POL, 84-200

  • Novartis Investigative Site

    Wroclaw, 50-445

  • Novartis Investigative Site

    Zawadzkie, 47-120

Other trials in Poland

Canada12 sites

  • Novartis Investigative Site

    Burlington, Ontario, L7N 3V2

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1L5

  • Novartis Investigative Site

    Québec, G1V 4W2

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

  • Novartis Investigative Site

    Sherwood Park, Alberta, T8H 0N2

  • Novartis Investigative Site

    Toronto, Ontario, M5T 3A9

  • Novartis Investigative Site

    Toronto, Ontario, M6H 3M2

  • Novartis Investigative Site

    Toronto, Ontario, M9V 4B4

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8T 7A1

  • Novartis Investigative Site

    Victoriaville, Quebec, G6P 6P6

  • Novartis Investigative Site

    Windsor, Ontario, N8X 2G1

  • Novartis Investigative Site

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Spain12 sites

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Cáceres, Extremadura, 10003

  • Novartis Investigative Site

    Esparraguera, Barcelona, 08292

  • Novartis Investigative Site

    Girona, Catalonia, 17007

  • Novartis Investigative Site

    Laredo, Cantabria, 39770

  • Novartis Investigative Site

    León, 24071

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Marbella, Andalusia, 29603

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Valencia, Valencia, 46015

  • Novartis Investigative Site

    Vila-real, Castellon, 12540

  • Novartis Investigative Site

    Zaragoza, 50015

Other trials in Spain

Belgium11 sites

  • Novartis Investigative Site

    Braine L Alleud Waterloo, 1420

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Éghezée, 5310

  • Novartis Investigative Site

    Erpent, 5100

  • Novartis Investigative Site

    Gosselies, BEL, 6041

  • Novartis Investigative Site

    Hasselt, BEL, 3500

  • Novartis Investigative Site

    Jette, Brussels Capital, 1090

  • Novartis Investigative Site

    Lebbeke, 9280

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Malmedy, 4960

Other trials in Belgium

Lithuania11 sites

  • Novartis Investigative Site

    Kaunas, LT, LT-50128

  • Novartis Investigative Site

    Kaunas, LT-44320

  • Novartis Investigative Site

    Kaunas, LT-45130

  • Novartis Investigative Site

    Kaunas, LT-49449

  • Novartis Investigative Site

    Kaunas, LT-50154

  • Novartis Investigative Site

    Klaipėda, LT-92231

  • Novartis Investigative Site

    Klaipėda, LT-92288

  • Novartis Investigative Site

    Šiauliai, LT-76231

  • Novartis Investigative Site

    Vilnius, LTU, LT-04129

  • Novartis Investigative Site

    Vilnius, LT, 01117

  • Novartis Investigative Site

    Vilnius, 06122

Other trials in Lithuania

Slovakia11 sites

  • Novartis Investigative Site

    Kežmarok, 060 01

  • Novartis Investigative Site

    Košice, Slovak Republic, 040 01

  • Novartis Investigative Site

    Košice, Slovak Republic, 04001

  • Novartis Investigative Site

    Košice, 04001

  • Novartis Investigative Site

    Liptovský Mikuláš, 031 23

  • Novartis Investigative Site

    Poprad, 058 01

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    Prešov, 080 01

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    Spišská Nová Ves, 052 01

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    Trenčín, 91101

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    Žilina, 01207

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    Zvolen, 960 01

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Italy10 sites

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    Ancona, 60127

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Catania, CT, 95125

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    Catanzaro, CZ, 88100

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    Florence, FI, 50134

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    Messina, ME, 98125

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    Messina, 98125

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    Negrar, VR, 37024

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    Pordenone, 33170

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    Roma, 00168

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Latvia10 sites

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    Balvi, LVA, 4501

  • Novartis Investigative Site

    Bauska, LVA, LV-3901

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    Daugavpils, LVA, LV-5417

  • Novartis Investigative Site

    Daugavpils, LV-5401

  • Novartis Investigative Site

    Jūrmala, LVA, LV-2015

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    Rēzekne, LVA, LV-4600

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    Riga, LVA, 1021

  • Novartis Investigative Site

    Riga, LV, 1011

  • Novartis Investigative Site

    Riga, LV, LV-1038

  • Novartis Investigative Site

    Riga, LV 1002

Other trials in Latvia

Mexico9 sites

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    Culiacan, State of Mexico, 80020

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44100

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44130

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    Guadalajara, Jalisco, 44160

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    Guadalajara, Jalisco, 44670

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    Monterrey, Nuevo León, 64460

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    Oaxaca City, 68000

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    Veracruz, 91700

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    Zapopan, Jalisco, 45200

Other trials in Mexico

Netherlands9 sites

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    Breda, CK, 4818

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    Eindhoven, 5623 EJ

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    Groningen, 9713 GZ

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    Harderwijk, 3840 AC

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    Heerlen, 6419 PC

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    Helmond, 5707 HA

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    Hengelo, 7555 DL

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    Rotterdam, 3045 PM

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    Zutphen, 7207 AE

Other trials in Netherlands

Israel8 sites

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    Ashkelon, 78278

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    Beersheba, 8457108

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    Jerusalem, 91031

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    Kfar Saba, 4428164

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    Petah Tikva, 49100

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    Rehovot, 7610001

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    Tel Giborim, Holon, 58100

Other trials in Israel

Greece7 sites

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    Athens, GR, 115 27

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    Athens, 106 76

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    Athens, 175 62

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    Heraklion Crete, Greece, 711 10

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    Thessaloniki, GR, 564 03

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    Thessaloniki, GR, 564 29

  • Novartis Investigative Site

    Thessaloniki, GR, 570 10

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Bulgaria5 sites

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    Plovdiv, BGR, 4000

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    Rousse, 7002

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    Sofia, 1202

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    Sofia, 1463

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    Stara Zagora, 6000

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Chile5 sites

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    Curicó, Maule Region, 3341643

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500692

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    Santiago, 9100

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    Santiago

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    Valparaíso, TX, 2341131

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Peru5 sites

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    Lima, 14

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    Lima Cercado, Lima region, 01

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    San Borja, Lima region, 41

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    San Isidro, Lima region, 27

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    San Miguel, Lima region, 32

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Philippines5 sites

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    Bulacan, 3020

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    Lipa City, Batangas, 4217

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    Manila, National Capital Region, 1000

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    Manila, 1000

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    Quezon City, 1102

Other trials in Philippines

South Africa5 sites

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    Berea, Durban, 4001

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    Cape Town, 7531

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    Cape Town, 7700

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    Durban, KwaZulu-Natal, 4093

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    Kempton Park, ZAF, 1619

Other trials in South Africa

Thailand5 sites

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    Bangkok, 10400

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    Bangkok, 26120

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    Chiang Mai, 50200

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    Khon Kaen, THA, 40002

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    Muang, Changwat Nonthaburi, 11000

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Austria4 sites

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    Bludenz, 6700

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    Feldbach, 8330

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    Feldkirch, 6800

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    Grieskirchen, 4710

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Colombia4 sites

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    Bogotá, 110221

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    Bogota DC, 110221

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    Floridablanca

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    Medellín

Other trials in Colombia

Croatia4 sites

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    Petrinja, 44250

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    Zadar, 23000

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    Zagreb, HRV, 10 000

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    Zagreb, 10000

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Estonia4 sites

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    Tallinn, 10117

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    Tallinn, 10138

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    Tallinn, 13419

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    Tartu, 51014

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Lebanon4 sites

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    Beirut, 1107 2020

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    Beirut, 166378

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    El Achrafiyé, 166830

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    El Chouf, LBN, 1503201002

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Portugal4 sites

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    Coimbra, 3000-075

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    Coimbra, 3041-853

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    Lisbon, 1998-018

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    Porto, 4100-180

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United Kingdom3 sites

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    East Yorkshire, HU16 5JQ

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    London, EC1M 6BQ

  • Novartis Investigative Site

    Wiltshire, SN15 2SB

Other trials in United Kingdom

Vietnam3 sites

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    Hanoi, 100000

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    Ho Chi Minh City, VNM, 700000

  • Novartis Investigative Site

    Ho Chi Minh City, 700000

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Denmark2 sites

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    Copenhagen NV, 2400

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    Hvidovre, 2650

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Ireland2 sites

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    Dublin, 24

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    Wilton, Cork

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Jordan2 sites

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    Amman, JOR, 11152

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    Amman, JOR, 11183

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Sweden2 sites

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    Lidingö, 181 58

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    Stockholm, 111 57

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Finland1 site

  • Novartis Investigative Site

    Jyväskylä, 40100

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France1 site

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    Montpellier, Herault, 34059

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Switzerland1 site

  • Novartis Investigative Site

    Gossau, 9200

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About this study

Official title: A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

Read the detailed description

This study used a 52-week treatment, randomized, double-blind, double-dummy, parallel-group design. A total of 3092 asthma patients were randomized into the 5 treatment groups with a randomization ratio of 1:1:1:1:1 (approximately 617 patients per treatment group): QVM149 150/50/80 μg once daily (o.d.), QVM149 150/50/160 μg o.d., QMF149 150/160 μg o.d. and QMF149 150/320 μg o.d., all delivered via the Concept1 device, and salmeterol/fluticasone 50/500 μg twice daily (b.i.d.) delivered via Accuhaler. The 52 week treatment period was followed by a 30-day Follow-up.

The primary objective of this study was to demonstrate superiority of either QVM149 150/50/80 μg o.d. to QMF149 150/160 μg o.d. or QVM149 150/50/160 μg o.d. to QMF149 150/320 μg o.d in terms of trough Forced Expiratory Volume in One Second (Trough FEV1) (FEV1) at Week 26, all delivered via Concept1.

Conditions
Asthma
Being tested
QVM149 150/50/160, QVM149 150/50/80, QMF149 150/320, QMF149 150/160, salmeterol/fluticasone
Keywords
Asthma, QVM149, QMF149
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QVM149 150/50/160Drug

  • QVM149 150/50/80Drug

  • QMF149 150/320Drug

  • QMF149 150/160Drug

  • salmeterol/fluticasoneDrug

Study groups in NCT02571777
Study groupRoleWhat they receive
QVM149 150/50/160 µg o.d.ExperimentalQVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Receives: Drug: QVM149 150/50/160
QVM149 150/50/80 µg o.d.ExperimentalQVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Receives: Drug: QVM149 150/50/80
QMF149 150/320 µg o.d.Active comparatorQMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Receives: Drug: QMF149 150/320
QMF149 150/160 µg o.d.Active comparatorQMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Receives: Drug: QMF149 150/160
Salmeterol/fluticasone 50/500 μg b.i.d.Active comparatorSalmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Receives: Drug: salmeterol/fluticasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26

    Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

    The primary endpoint considered the following 2 comparison groups:

    • QVM149 150/50/80 μg o.d. compared with QMF149 150/160 μg o.d. both delivered via Concept1
    • QVM149 150/50/160 μg o.d. compared with QMF149 150/320 μg o.d. both delivered via Concept1.

    Measured: 26 weeks

Secondary outcomes (23)

  1. Asthma Control Questionnaire (ACQ-7) at Week 26 and Week 52

    The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The ACQ-7 total score reported below was calculated as the mean of scores of all 7 items and ranged between 0 and 6, with higher scores indicating worse asthma symptom control.

    Measured: 26 weeks, 52 weeks

  2. Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus Salmeterol/Fluticasone at Week 26

    Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

    This secondary endpoint considered the following 2 comparison groups:

    • QVM149 150/50/80 μg o.d. via Concept1 compared with salmeterol/fluticasone 50/500 μg b.i.d. via Accuhaler®
    • QVM149 150/50/160 μg o.d. via Concept 1 compared with salmeterol/fluticasone 50/500 μg b.i.d. via Accuhaler®

    Measured: 26 weeks

  3. Trough FEV1 at Week 52

    Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

    Measured: 52 weeks

  4. Pre-dose Forced Vital Capacity (FVC) at Week 4 and Week 12

    Pre-dose FVC is defined as average of the two FVC measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FVC is the total amount of air exhaled during the FEV test.

    Measured: 4 weeks, 12 weeks

  5. Trough Forced Expiratory Flow (FEF) Between 25% and 75% of FVC (FEF25-75) at 52 Weeks

    FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.

    Measured: Up to Week 52

  6. Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment

    PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose) at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used.

    Measured: Baseline, 26 weeks, 52 weeks

  7. Change From Baseline in Percentage of Asthma Symptom-free Days Over 52 Weeks

    All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms.

    Measured: Baseline, 52 weeks

  8. Change From Baseline in Percentage of Days With no Daytime Symptoms Over 52 Weeks

    All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).

    Measured: Baseline, 52 weeks

  9. Change From Baseline in Percentage of Nights With no Night-time Awakenings Over 52 Weeks

    All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).

    Measured: Baseline, 52 weeks

  10. Change From Baseline in Percentage of Mornings With no Symptoms on Rising Over 52 Weeks

    All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).

    Measured: Baseline, 52 weeks

  11. Change From Baseline in Percentage of Days Without Rescue Medication Use Over 26 and 52 Weeks

    Percentage of days without rescue medication usage (100 μg salbutamol/90 μg albuterol via metered-dose inhaler) as recorded by e-diary over 26 and 52 weeks of treatment.

    Measured: Baseline, 26 weeks, 52 weeks

  12. Percentage of Patients Achieving the Minimal Clinically Important Difference (MCID) ACQ ≥ 0.5 at Week 26 and Week 52

    Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions.

    Measured: 26 weeks, 52 weeks

  13. Time to First Hospitalization for Asthma Exacerbation

    Time from start of treatment until the first event (hospitalization for asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the start date of the hospitalization was considered to calculate the time to event (i.e., the number of days from start of treatment up to the event start date).

    Measured: 52 weeks on average, up to 416 days

  14. Time to First Asthma Exacerbation by Exacerbation Category

    Time from start of treatment until the first event (asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the start date of the exacerbation was considered to calculate the time to event (i.e., the number of days from start of treatment up to the event start date).

    The exacerbation categories were: All (mild, moderate and severe), combination of moderate or severe and severe.

    Measured: 52 weeks on average, up to 416 days

  15. Annual Rate of Asthma Exacerbations by Exacerbation Category

    The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

    Measured: 52 weeks

  16. Duration in Days of Asthma Exacerbations by Exacerbation Category

    The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

    Measured: Up to Week 52

  17. Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category

    The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

    Measured: Up to Week 52

  18. Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbation

    Time from start of treatment until the first event (permanent discontinuation of study medication due to asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the date of the discontinuation of study medication was considered to calculate the time to event.

    Measured: 52 weeks on average, up to 416 days

  19. Total Amount of Oral Corticosteroid Used (in Prednisone-equivalent mg Doses) to Treat Asthma Exacerbations

    The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days.

    Measured: Up to Week 52

  20. Change From Baseline in Percentage of Rescue Medication Free Days Over 26 and 52 Weeks

    All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time.

    Measured: Baseline, 26 weeks, 52 weeks

  21. Asthma Quality of Life Questionnaire (AQLQ) at Week 52

    AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains:

    • Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items)
    • Activity limitation = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items)
    • Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items)
    • Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items)
    • Overall Score = Mean of Items 1 to 32 (32 items) The overall AQLQ score reported below is the mean of all 32 responses and ranges from 1 to 7, where higher scores indicate better quality of life.

    Measured: 52 weeks

  22. Pre-dose FEV1 at Weeks 4 and 12

    Pre-dose FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

    Measured: 4 weeks, 12 weeks

  23. Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes

    A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee.

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2015 (estimated)
  2. Study start8 Dec 2015
  3. Primary completion14 Jun 2019
  4. Study completion14 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,092 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02571777
Sponsor's protocol ID
CQVM149B2302
Other IDs
2015-002899-25, 2015
Status last verified
Jul 2020
First submitted
5 Oct 2015
Last updated
22 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Publications

  • van Zyl-Smit RN, Kerstjens HAM, Maspero J, Tanase AM, Lawrence D, Mezzi K, D'Andrea P, Chapman KR. Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses. Pulm Ther. 2023 Sep;9(3):395-409. doi: 10.1007/s41030-023-00234-y. Epub 2023 Aug 1.

    PubMed 37526856

  • Kostikas K, Maspero JF, Chapman KR, Mezzi K, Jaumont X, Lawrence D, van Zyl-Smit R. Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study. Respir Med. 2023 Oct;217:107334. doi: 10.1016/j.rmed.2023.107334. Epub 2023 Jun 29.

    PubMed 37392789

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PubMed 36472162

  • Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1):e000819. doi: 10.1136/bmjresp-2020-000819.

    PubMed 34452934

  • Kerstjens HAM, Maspero J, Chapman KR, van Zyl-Smit RN, Hosoe M, Tanase AM, Lavecchia C, Pethe A, Shu X, D'Andrea P; IRIDIUM trial investigators. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):1000-1012. doi: 10.1016/S2213-2600(20)30190-9. Epub 2020 Jul 9.

    PubMed 32653074

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVM149 150/50/160, QVM149 150/50/80 and QMF149 150/320 in people with Asthma, run by Novartis Pharmaceuticals at 403 sites in 41 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 403 sites in Russia, India, Germany, Argentina, Japan and 36 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26 (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02571777, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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