AzTrials
AzTrials

AsthmaPhase 3NCT02554786

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

A Phase 3 study testing Indacaterol acetate/Mometasone furoate, Mometasone furoate and Salmeterol xinafoate/fluticasone propionate in people with Asthma, run by Novartis Pharmaceuticals at 388 sites in 24 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 is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary… Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Asthma
What is being tested?
Indacaterol acetate/Mometasone furoate, Mometasone furoate and Salmeterol xinafoate/fluticasone propionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,216 participants
Where
388 sitesin 24 countries
Study dates
29 Dec 2015to 28 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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
  • Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
  • Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
  • Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of < 85 % of the predicted normal value for the participants after withholding bronchodilators at both Visit 101 and 102, according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria.
  • Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short acting anticholinergics (SAMA) for ≥ 8 hours, xanthines >=07 days
  • A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102.
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  • Spacer devices are permitted for reversibility testing only.
  • -Participants 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 participants must perform a reversibility test at Visit 101
  • If reversibility is not demonstrated at Visit 101:
  • Reversibility should be repeated once-
  • Participants 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, participants may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1.

Who cannot join

  • Participants who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
  • Participants who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
  • Participants who have ever required intubation for a severe asthma attack/exacerbation.
  • Participants 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).
  • Participants who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Participants may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
  • Participants with a history of chronic lung diseases other than asthma, including (but not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
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  • Participants with severe narcolepsy and/or insomnia.
  • Participants who have a clinically significant electrocardiogram (ECG) abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
  • Participants 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
  • Participants who have not achieved an acceptable spirometry results at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability (rescreening allowed only once).
  • Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant may be rescreened once
  • Participants on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or participants on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 30 days after stopping of study treatment.
  • Long acting muscarinic antagonist (LAMA) use within 3 months prior to Visit 101

Trial locations and contacts

388 sites in 24 countries.

388 sites in 24 countries

Germany56 sites

  • Novartis Investigative Site

    Ahlen, 59229

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Berlin, 10119

  • Novartis Investigative Site

    Berlin, 10247

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 10717

  • Novartis Investigative Site

    Berlin, 10787

  • Novartis Investigative Site

    Berlin, 10969

  • Novartis Investigative Site

    Berlin, 12157

  • Novartis Investigative Site

    Berlin, 12159

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 12627

  • Novartis Investigative Site

    Berlin, 13057

  • Novartis Investigative Site

    Berlin, 13086

  • Novartis Investigative Site

    Berlin, 13156

  • Novartis Investigative Site

    Berlin, 13187

  • Novartis Investigative Site

    Bochum, D-44787

  • Novartis Investigative Site

    Böhlen, 04564

  • Novartis Investigative Site

    Bonn, 53119

  • Novartis Investigative Site

    Delitzsch, 04509

  • Novartis Investigative Site

    Dresden, 01069

  • Novartis Investigative Site

    Düren, 52349

  • Novartis Investigative Site

    Düsseldorf, 40211

  • Novartis Investigative Site

    Erlangen, 91052

  • Novartis Investigative Site

    Frankfurt, 60313

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Fürstenwalde, 15517

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22143

  • Novartis Investigative Site

    Hamburg, 22299

  • Novartis Investigative Site

    Hamburg, 22335

  • Novartis Investigative Site

    Hanover, 30173

  • Novartis Investigative Site

    Hochstadt, 91315

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Koblenz, Rhineland-Palatinate, 56068

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04109

  • Novartis Investigative Site

    Leipzig, 04207

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Lübeck, 23552

  • Novartis Investigative Site

    Ludwigsburg, 71640

  • Novartis Investigative Site

    Marburg, D-35037

  • Novartis Investigative Site

    Mittweida, 09648

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    Neu-Isenburg, 63263

  • Novartis Investigative Site

    Neuss, 41462

  • Novartis Investigative Site

    Peine, Lower Saxony, 31224

  • Novartis Investigative Site

    Potsdam, 14467

  • Novartis Investigative Site

    Potsdam, 14469

  • Novartis Investigative Site

    Rheine, 48431

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Schleswig, 24837

  • Novartis Investigative Site

    Schwedt, 16303

  • Novartis Investigative Site

    Weinheim, 69469

  • Novartis Investigative Site

    Witten, 58452

Other trials in Germany

Russia36 sites

  • Novartis Investigative Site

    Chelyabinsk, 454021

  • Novartis Investigative Site

    Chelyabinsk, 454076

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    Krasnoyarsk, 660022

  • Novartis Investigative Site

    Moscow, 105275

  • Novartis Investigative Site

    Moscow, 119192

  • Novartis Investigative Site

    N.Novgorod, 603126

  • Novartis Investigative Site

    Novosibirsk, 630047

  • Novartis Investigative Site

    Novosibirsk, 630099

  • Novartis Investigative Site

    Penza, 440067

  • Novartis Investigative Site

    Petrozavodsk, 185019

  • Novartis Investigative Site

    Pyatigorsk, 357538

  • Novartis Investigative Site

    Ryazan, 390026

  • Novartis Investigative Site

    Ryazan, 390039

  • Novartis Investigative Site

    Saint Petersburg, 190044

  • Novartis Investigative Site

    Saint Petersburg, 191015

  • Novartis Investigative Site

    Saint Petersburg, 191123

  • Novartis Investigative Site

    Saint Petersburg, 191180

  • Novartis Investigative Site

    Saint Petersburg, 192257

  • Novartis Investigative Site

    Saint Petersburg, 193312

  • Novartis Investigative Site

    Saint Petersburg, 194223

  • Novartis Investigative Site

    Saint Petersburg, 194291

  • Novartis Investigative Site

    Saint Petersburg, 194354

  • Novartis Investigative Site

    Saint Petersburg, 196240

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Saratov, 410053

  • Novartis Investigative Site

    Smolensk, 214006

  • Novartis Investigative Site

    Smolensk, 214031

  • Novartis Investigative Site

    Stavropol, 355000

  • Novartis Investigative Site

    Volgograd, 400120

  • Novartis Investigative Site

    Vologodonsk, 347382

  • Novartis Investigative Site

    Yaroslavl, Russian Federation, 150023

  • Novartis Investigative Site

    Yaroslavl, 150000

  • Novartis Investigative Site

    Yaroslavl, 150003

  • Novartis Investigative Site

    Yaroslavl, 150040

  • Novartis Investigative Site

    Yekaterinburg, 620137

Other trials in Russia

China33 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100044

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100730

  • Novartis Investigative Site

    Beijing, 100029

  • Novartis Investigative Site

    Beijing, 100191

  • Novartis Investigative Site

    Beijing, 100730

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Changsha, Hunan, 410011

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Chengdu, 610083

  • Novartis Investigative Site

    Chongqing, 400038

  • Novartis Investigative Site

    Fuzhou, Fujian, 350025

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510120

  • Novartis Investigative Site

    Guangzhou, 510000

  • Novartis Investigative Site

    Guangzhou, 510080

  • Novartis Investigative Site

    Guangzhou, 510180

  • Novartis Investigative Site

    Haikou, Hainan, 570311

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310014

  • Novartis Investigative Site

    Nanchang, 330006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200032

  • Novartis Investigative Site

    Shanghai, 200092

  • 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

    Shijiazhuang, Hebei, 050000

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215006

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

  • Novartis Investigative Site

    Xian, Shanxi, 710061

Other trials in China

Japan31 sites

  • Novartis Investigative Site

    Atsugi, Kanagawa, 243-0034

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 103 0027

  • Novartis Investigative Site

    Chuou-ku, Tokyo, 103-0028

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 819-8555

  • Novartis Investigative Site

    Himeji, Hyōgo, 671-0102

  • Novartis Investigative Site

    Himeji, Hyōgo, 672-8064

  • Novartis Investigative Site

    Ichihara, Chiba, 299-0111

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 173-8610

  • Novartis Investigative Site

    Kasuga, Fukuoka, 816-0813

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 255

  • Novartis Investigative Site

    Kishiwada, Osaka, 596-8501

  • Novartis Investigative Site

    Koshigaya, Saitama, 343-8555

  • 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

    Osaka, Osaka, 530 0001

  • Novartis Investigative Site

    Sendai, Miyagi, 980-0871

  • Novartis Investigative Site

    Setagaya-Ku, Tokyo, 157-0072

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 162-0053

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 169-0073

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-1192

  • Novartis Investigative Site

    Tokyo, Shibuya Ku, 150 0013

  • Novartis Investigative Site

    Toshima Ku, Tokyo, 170 0003

  • Novartis Investigative Site

    Toshima-ku, Tokyo, 171-0014

  • Novartis Investigative Site

    Toyonaka, Osaka

  • Novartis Investigative Site

    Yanagawa, Fukuoka, 832-0059

  • Novartis Investigative Site

    Yao, Osaka, 581-0011

  • 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, 236-0004

Other trials in Japan

United States29 sites

  • Novartis Investigative Site

    Baltimore, Maryland, 21236

  • Novartis Investigative Site

    Bellevue, Nebraska, 68123

  • Novartis Investigative Site

    Birmingham, Alabama, 35244

  • Novartis Investigative Site

    Boerne, Texas, 78006

  • Novartis Investigative Site

    Cortland, New York, 13045

  • Novartis Investigative Site

    Denver, Colorado, 80230

  • Novartis Investigative Site

    El Paso, Texas, 79903

  • Novartis Investigative Site

    Greenfield, Wisconsin, 53228

  • Novartis Investigative Site

    Las Vegas, Nevada, 89119

  • Novartis Investigative Site

    Los Angeles, California, 90025

  • Novartis Investigative Site

    Medford, Oregon, 97504

  • Novartis Investigative Site

    Miami, Florida, 33144

  • Novartis Investigative Site

    North Charleston, South Carolina, 29407

  • Novartis Investigative Site

    North Dartmouth, Massachusetts, 02747-3322

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73120

  • Novartis Investigative Site

    Orange, California, 92868

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15241

  • Novartis Investigative Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Riverside, California, 92506

  • Novartis Investigative Site

    San Diego, California, 92117

  • Novartis Investigative Site

    San Jose, California, 95117

  • Novartis Investigative Site

    Skillman, New Jersey, 08558

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Stockton, California, 95207

  • Novartis Investigative Site

    Tallahassee, Florida, 32308

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74136

  • Novartis Investigative Site

    Waldorf, Maryland, 20602

  • Novartis Investigative Site

    Westminster, California, 92683

  • Novartis Investigative Site

    Winter Park, Florida, 32789

Other trials in United States

Slovakia28 sites

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01

  • Novartis Investigative Site

    Bardejov, 085 01

  • Novartis Investigative Site

    Bojnice, Slovak Republic, 972 01

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 83103

  • Novartis Investigative Site

    Bratislava, 85101

  • Novartis Investigative Site

    Čadca, 022 01

  • Novartis Investigative Site

    Humenné, Slovak Republic, 066 01

  • Novartis Investigative Site

    Ilava, 1901

  • Novartis Investigative Site

    Komárno, 945 01

  • Novartis Investigative Site

    Košice, Slovak Republic, 040 01

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Košice, 04001

  • Novartis Investigative Site

    Kráľovský Chlmec, 077 01

  • Novartis Investigative Site

    Levice, 034 01

  • Novartis Investigative Site

    Liptovský Mikuláš, 031 23

  • Novartis Investigative Site

    Námestovo, Slovensko, 02901

  • Novartis Investigative Site

    Nitra, Slovak Republic, 949 01

  • Novartis Investigative Site

    Poprad, SVK, 058 01

  • Novartis Investigative Site

    Prešov, 080 01

  • Novartis Investigative Site

    Prievidza, 97101

  • Novartis Investigative Site

    Skalica, Slovak Republic, 90901

  • Novartis Investigative Site

    Spišská Nová Ves, Slovak Republic, 052 01

  • Novartis Investigative Site

    Stropkov, Slovak Republic, 09101

  • Novartis Investigative Site

    Šurany, Slovak Republic, 942 01

  • Novartis Investigative Site

    Topoľčany, 95501

  • Novartis Investigative Site

    Veľký Meder, Slovak Republic, 94201

  • Novartis Investigative Site

    Žilina, 010 01

  • Novartis Investigative Site

    Žilina, 01001

Other trials in Slovakia

Hungary26 sites

  • Novartis Investigative Site

    Balassagyarmat, 2660

  • Novartis Investigative Site

    Budapest, HUN, 1037

  • Novartis Investigative Site

    Budapest, HUN, 1089

  • Novartis Investigative Site

    Budapest, HUN, 1117

  • Novartis Investigative Site

    Budapest, HUN, 1204

  • Novartis Investigative Site

    Budapest, 1106

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Cegléd, 2700

  • Novartis Investigative Site

    Csorna, H-9300

  • Novartis Investigative Site

    Dombóvár, 7200

  • Novartis Investigative Site

    Gödöllő, 2100

  • Novartis Investigative Site

    Győr, HUN, 9024

  • Novartis Investigative Site

    Hajdúnánás, HUN, 4080

  • Novartis Investigative Site

    Hatvan, 3000

  • Novartis Investigative Site

    Komárom, 2900

  • Novartis Investigative Site

    Makó, HUN, 6900

  • Novartis Investigative Site

    Miskolc, HUN, 3529

  • Novartis Investigative Site

    Miskolc, 3526

  • Novartis Investigative Site

    Mosdós, 7257

  • Novartis Investigative Site

    Püspökladány, HUN, 4150

  • Novartis Investigative Site

    Szarvas, 5540

  • Novartis Investigative Site

    Százhalombatta, HUN, 2440

  • Novartis Investigative Site

    Szeged, 6720

  • Novartis Investigative Site

    Szeged, 6722

  • Novartis Investigative Site

    Szigetvár, 7900

  • Novartis Investigative Site

    Szombathely, 9700

Other trials in Hungary

Romania24 sites

  • Novartis Investigative Site

    Arad, 310013

  • Novartis Investigative Site

    Bacau, 600114

  • Novartis Investigative Site

    Bragadiru, 077025

  • Novartis Investigative Site

    Brăila, 810003

  • Novartis Investigative Site

    Brasov, 500051

  • Novartis Investigative Site

    Bucharest, ROM, 12071

  • Novartis Investigative Site

    Bucharest, 012363

  • Novartis Investigative Site

    Bucharest, 020125

  • Novartis Investigative Site

    Bucharest, 050554

  • Novartis Investigative Site

    Cluj-Napoca, 400275

  • Novartis Investigative Site

    Cluj-Napoca, 400371

  • Novartis Investigative Site

    Codlea, 505100

  • Novartis Investigative Site

    Constanța, Jud. Constanta, 900002

  • Novartis Investigative Site

    Craiova, Jud.Dolj, 200341

  • Novartis Investigative Site

    Craiova, ROM, 000000

  • Novartis Investigative Site

    Craiova, ROM, 200712

  • Novartis Investigative Site

    Craiova, 200515

  • Novartis Investigative Site

    Deva, ROM, 330084

  • Novartis Investigative Site

    Iași, Jud Iasi, 700732

  • Novartis Investigative Site

    Râmnicu Vâlcea, 240564

  • Novartis Investigative Site

    Suceava, 720284

  • Novartis Investigative Site

    Târgu Mureş, 540072

  • Novartis Investigative Site

    Timișoara, ROM, 300298

  • Novartis Investigative Site

    Timișoara, Timiș County, 300310

Other trials in Romania

Czechia19 sites

  • Novartis Investigative Site

    Beroun, Czech Republic, 266 01

  • Novartis Investigative Site

    Boskovice, Czech Republic, 680 01

  • Novartis Investigative Site

    Břeclav, 690 02

  • Novartis Investigative Site

    Český Krumlov, 381 01

  • Novartis Investigative Site

    Jablonec nad Nisou, Czech Republic, 466 01

  • Novartis Investigative Site

    Jindřichův Hradec, Czech Republic, 377 01

  • Novartis Investigative Site

    Kuřim, Czech Republic, 66434

  • Novartis Investigative Site

    Kutná Hora, 28401

  • Novartis Investigative Site

    Nový Bor, 47301

  • Novartis Investigative Site

    Ostrava, CZE, 709 00

  • Novartis Investigative Site

    Pilsen, CZE, 301 00

  • Novartis Investigative Site

    Pilsen, 323 00

  • Novartis Investigative Site

    Prague, Czech Republic, 14800

  • Novartis Investigative Site

    Prague, 182 00

  • Novartis Investigative Site

    Rokycany, 337 22

  • Novartis Investigative Site

    Tábor, 390 01

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

  • Novartis Investigative Site

    Teplice, CZE, 415 01

  • Novartis Investigative Site

    Varnsdorf, Czech Republic, 40747

Other trials in Czechia

India19 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 008

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380016

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302001

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302013

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302020

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302023

  • Novartis Investigative Site

    Kozhikode, Kerala, 673008

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226003

  • Novartis Investigative Site

    Mohali, Punjab, 160 062

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400601

  • Novartis Investigative Site

    Mysore, Karnataka, 570001

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440010

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440012

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440019

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110007

  • Novartis Investigative Site

    New Delhi, 110029

  • Novartis Investigative Site

    Pune, Maharashtra, 411007

  • Novartis Investigative Site

    Vadodara, Gujarat, 390021

Other trials in India

Poland14 sites

  • Novartis Investigative Site

    Aleksandrow Odzki, Poland, 95-070

  • Novartis Investigative Site

    Biaystok, Poland, 15-430

  • Novartis Investigative Site

    Bielsko-Biala, 43-300

  • Novartis Investigative Site

    Elblag, 82-300

  • Novartis Investigative Site

    Inowrocław, 88-100

  • Novartis Investigative Site

    Katowice, 40 085

  • Novartis Investigative Site

    Krakow, 30033

  • Novartis Investigative Site

    Lodz, POL, 91-110

  • Novartis Investigative Site

    Lodz, 90-302

  • Novartis Investigative Site

    Ostrów Wielkopolski, 63-400

  • Novartis Investigative Site

    Sopot, 81-741

  • Novartis Investigative Site

    Warsaw, 01518

  • Novartis Investigative Site

    Wejherowo, POL, 84-200

  • Novartis Investigative Site

    Zawadzkie, 47-120

Other trials in Poland

United Kingdom12 sites

  • Novartis Investigative Site

    Blackpool, FY5 3LF

  • Novartis Investigative Site

    Bristol, South Gloucestershire, BS37 4AX

  • Novartis Investigative Site

    Denbighshire, LL181DA

  • Novartis Investigative Site

    Faringdon, Oxfordshire, SN7 7YU

  • Novartis Investigative Site

    Fowey, Cornwall, PL23 1DT

  • Novartis Investigative Site

    Glasgow, G20 0XA

  • Novartis Investigative Site

    Liskeard, Cornwall, PL14 3XA

  • Novartis Investigative Site

    London, EC14 7BE

  • Novartis Investigative Site

    London, SE5 8AD

  • Novartis Investigative Site

    Rotherham, S65 1DA

  • Novartis Investigative Site

    Torpoint, Cornwall, PL11 2TB

  • Novartis Investigative Site

    Wiltshire, SN15 2SB

Other trials in United Kingdom

Bulgaria11 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Plovdiv, BGR, 4000

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Rousse, 7002

  • Novartis Investigative Site

    Sofia, 1407

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Sofia

  • Novartis Investigative Site

    Stara Zagora, 6000

  • Novartis Investigative Site

    Troyan Municipality, 5600

  • Novartis Investigative Site

    Varna, BGR, 9000

  • Novartis Investigative Site

    Vidin, BGR, 3703

Other trials in Bulgaria

South Korea8 sites

  • Novartis Investigative Site

    Bucheon-si, Gyeonggi-do, 14584

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620

  • Novartis Investigative Site

    Cheongju-si, North Chungcheong, 28644

  • Novartis Investigative Site

    Incheon, 403-720

  • Novartis Investigative Site

    Seoul, Korea, 03312

  • Novartis Investigative Site

    Seoul, Korea, 08308

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

  • Novartis Investigative Site

    Wŏnju, Gangwon-do, 26427

Other trials in South Korea

Croatia6 sites

  • Novartis Investigative Site

    Petrinja, 44250

  • Novartis Investigative Site

    Rijeka, 51000

  • Novartis Investigative Site

    Varaždin, HRV, 42000

  • Novartis Investigative Site

    Zadar, 23000

  • Novartis Investigative Site

    Zagreb, HRV, 10 000

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Guatemala6 sites

  • Novartis Investigative Site

    Ciudad, Gautemala, 01010

  • Novartis Investigative Site

    Guatemala City, GTM, 01010

  • Novartis Investigative Site

    Guatemala City, GTM, 01011

  • Novartis Investigative Site

    Guatemala City, 01010

  • Novartis Investigative Site

    Guatemala City, 01011

  • Novartis Investigative Site

    Guatemala City, 01057

Other trials in Guatemala

South Africa6 sites

  • Novartis Investigative Site

    Belleville, South Africa, 7530

  • Novartis Investigative Site

    Berea, Durban, 4001

  • Novartis Investigative Site

    Cape Town, 7531

  • Novartis Investigative Site

    Cape Town, 7700

  • Novartis Investigative Site

    Cape Town, 7925

  • Novartis Investigative Site

    Panorama, Western Cape, 7500

Other trials in South Africa

Lithuania5 sites

  • Novartis Investigative Site

    Kaunas, LTU, LT-48259

  • Novartis Investigative Site

    Kaunas, LT-49449

  • Novartis Investigative Site

    Šiauliai, LT-76231

  • Novartis Investigative Site

    Utena, LT-28151

  • Novartis Investigative Site

    Vilnius, LT-09108

Other trials in Lithuania

Serbia5 sites

  • Novartis Investigative Site

    Belgrade, Serbia, 11000

  • Novartis Investigative Site

    Belgrade, 11000

  • Novartis Investigative Site

    Kamenitz, 21204

  • Novartis Investigative Site

    Kragujevac, 34000

  • Novartis Investigative Site

    Niš, 18000

Other trials in Serbia

Latvia4 sites

  • Novartis Investigative Site

    Daugavpils, LV-5401

  • Novartis Investigative Site

    Riga, LV, 1011

  • Novartis Investigative Site

    Riga, LV 1002

  • Novartis Investigative Site

    Riga, LV-1001

Other trials in Latvia

Mexico4 sites

  • Novartis Investigative Site

    Mexicali, Estado de Baja California, 21100

  • Novartis Investigative Site

    México, 07760

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700

  • Novartis Investigative Site

    Mexico City, Mexico City, 14050

Other trials in Mexico

Ireland3 sites

  • Novartis Investigative Site

    County Limerick, V94 F858

  • Novartis Investigative Site

    Dublin, DUBLIN 8

  • Novartis Investigative Site

    Wilton, Cork

Other trials in Ireland

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 13619

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Egypt1 site

  • Novartis Investigative Site

    Alexandria, 21131

Other trials in Egypt

About this study

Official title: A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control

Conditions
Asthma
Being tested
Indacaterol acetate/Mometasone furoate, Mometasone furoate, Salmeterol xinafoate/fluticasone propionate
Keywords
QMF149, Mometasone furoate (MF), asthma
Medical subject headings
Asthma

What participants receive

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

  • Indacaterol acetate/Mometasone furoateDrug

    Also called QMF149

  • Mometasone furoateDrug

  • Salmeterol xinafoate/fluticasone propionateDrug

Study groups in NCT02554786
Study groupRoleWhat they receive
QMF149 150/160 µgExperimentalQMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening.
Receives: Drug: Indacaterol acetate/Mometasone furoate
QMF149 150/320 µgExperimentalQMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening.
Receives: Drug: Indacaterol acetate/Mometasone furoate
MF 400 µgActive comparatorMometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening
Receives: Drug: Mometasone furoate
Salmeterol /fluticasone 50/500 μgActive comparatorSalmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Receives: Drug: Salmeterol xinafoate/fluticasone propionate
MF 800 μgActive comparatorMF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
Receives: Drug: Mometasone furoate

What is being measured

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

  1. Trough Forced Expiratory Volume in One Second (Trough FEV1) 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.

    Measured: 26 weeks

Secondary outcomes (26)

  1. Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 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 total score was calculated as the mean of all questions.

    Measured: Weeks 4, 12, 26 and 52

  2. 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: Week 52

  3. Pre-dose FEV1 at Weeks 4 and 12

    Pre-dose trough 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: Weeks 4 (Day 30) and 12 (Day 86)

  4. Post Dose FEV1 (5 Minutes-1 Hour)

    Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. 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: Up to Week 52 (Day 364)

  5. Trough Forced Vital Capacity (FVC)

    FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC 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 (Day 365)

  6. Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)

    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 (Day 365)

  7. 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 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: Up to Weeks 26 and 52

  8. Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 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: Weeks 26 (Day 183) and 52 (Day 364)

  9. Change From Baseline in Percentage of Asthma Symptoms Free Days

    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: Up to Week 52

  10. Change Form Baseline in Percentage of Days With no Daytime Symptoms

    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: Up to Week 52

  11. Change From Baseline in Percentage of Nights With no Night-time Awakenings

    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: Up to Week 52

  12. Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening

    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 mornings with no symptoms on awakening was "Did you have asthma symptoms upon awakening in the morning?" to be answered with "None" with scores from 0 (no problem)-4 (very severe problems).

    Measured: Up to Week 52

  13. Rescue Medication Usage

    All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. The number of puffs of rescue medication during the past 12 hours is recorded twice (morning/evening) by the participant prior to taking study medication. The mean daily number of puffs of rescue medication use will be calculated for each participant, done separately for morning (night-time), evening (daytime), and daily (night-time plus daytime) rescue medication use

    Measured: Up to Weeks 26 and 52

  14. Time to First 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

  15. Time to First Hospitalization for Asthma Exacerbation

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

    Measured: Up to Week 52

  16. 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: Up to Week 52

  17. 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

  18. 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

  19. Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations

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

    Measured: Up to Week 52

  20. Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations

    Measured: Up to Week 52

  21. Total Amounts of Systemic Corticosteroids (in Doses) Used 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

  22. Change From Baseline in Percentage of Rescue Medication Free Days

    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: Up to Weeks 26 and 52

  23. Asthma Quality of Life Questionnaire (AQLQ)

    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)

    Measured: Up to Week 52 (Day 364)

  24. Trough FEV1 Measured After 26 Weeks of Treatment

    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: Week 26

  25. 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

  26. Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

    An AE is any untoward medical occurrence (i.e., any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. An SAE is defined as any adverse event (appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant, i.e. defined as an event that jeopardizes the participants or may require medical or surgical intervention.

    Measured: Approximately up to 56 weeks

Timeline

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

  1. First posted18 Sep 2015 (estimated)
  2. Study start29 Dec 2015
  3. Primary completion21 Nov 2018
  4. Study completion28 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
Double blind
Who is masked
Participant, Investigator
Enrolment
2,216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02554786
Sponsor's protocol ID
CQVM149B2301
Other IDs
2015-002529-21, 2015
Status last verified
Feb 2020
First submitted
9 Sep 2015
Last updated
5 Mar 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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

  • van Zyl-Smit RN, Krull M, Gessner C, Gon Y, Noga O, Richard A, de Los Reyes A, Shu X, Pethe A, Tanase AM, D'Andrea P; PALLADIUM trial investigators. Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):987-999. doi: 10.1016/S2213-2600(20)30178-8. Epub 2020 Jul 9.

    PubMed 32653075

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol acetate/Mometasone furoate, Mometasone furoate and Salmeterol xinafoate/fluticasone propionate in people with Asthma, run by Novartis Pharmaceuticals at 388 sites in 24 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 12 inclusion and 14 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 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 388 sites in Germany, Russia, China, Japan, United States and 19 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 5 Mar 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 One Second (Trough FEV1) 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 NCT02554786, which also lists 3 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 5 Mar 2020.

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