AsthmaPhase 2NCT01437735

Dose Finding Study for QAW039 in Asthma

A Phase 2 study testing QAW039 and Montelukast in people with Asthma, run by Novartis Pharmaceuticals at 206 sites in 22 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

This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: QAW039 and Montelukast
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,043 participants
Where: 206 sitesin 22 countries
Study dates: Aug 2011to Nov 2013
Phase: Phase 2
Are there results?: None posted in the registry

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy.
Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value of 40% to 80% of individual predicted value.
Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study.
Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year.
An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization.

Who cannot join

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.).
Acute illness other than asthma at the start of the study
History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma.
Patients who have had a respiratory tract infection within 4 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date.
Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.

Trial locations and contacts

206 sites in 22 countries.

Country

City, postcode or hospital

206 sites in 22 countries

Japan45 sites

Novartis Investigative Site
Asahikawa, Hokkaido, 070-8644
Novartis Investigative Site
Chiyoda-ku, Tokyo, 1020083
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0027
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0028
Novartis Investigative Site
Edogawa-ku, Tokyo, 134-0083
Novartis Investigative Site
Fukuoka, Fukuoka, 819-8555
Novartis Investigative Site
Fukuoka, 811-1394
Novartis Investigative Site
Habikino, Osaka, 583-8588
Novartis Investigative Site
Hamamatsu, Shizuoka, 430-8525
Novartis Investigative Site
Hamamatsu, Shizuoka, 430-8558
Novartis Investigative Site
Hamamatsu, Shizuoka, 434-8511
Novartis Investigative Site
Hatsukaichi, Hiroshima, 739-0402
Novartis Investigative Site
Higashiibaraki-gun, Ibaraki, 311-3193
Novartis Investigative Site
Himeji, Hyōgo, 672-8064
Novartis Investigative Site
Hiroshima, 732-0052
Novartis Investigative Site
Hitachi, Ibaraki, 317-0077
Novartis Investigative Site
Itabashi-ku, Tokyo, 173-8610
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920-0853
Novartis Investigative Site
Kasuga, Fukuoka, 816-0813
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0852
Novartis Investigative Site
Kishiwada, Osaka, 596-8501
Novartis Investigative Site
Kitakyushu, Fukuoka, 802-0083
Novartis Investigative Site
Kitakyushu, Fukuoka, 820-0052
Novartis Investigative Site
Kiyose, Tokyo, 204-8585
Novartis Investigative Site
Kochi, 780-8077
Novartis Investigative Site
Koshigaya, Saitama, 343-0851
Novartis Investigative Site
Kurashiki, Okayama-ken, 712-8064
Novartis Investigative Site
Kyoto, 612-0026
Novartis Investigative Site
Minato-ku, Tokyo, 108-8606
Novartis Investigative Site
Mizunami, Gifu, 509-6134
Novartis Investigative Site
Nishio, Aichi-ken, 445-8510
Novartis Investigative Site
Osaka, 560-0005
Novartis Investigative Site
Sagamihara, Kanagawa, 228-8522
Novartis Investigative Site
Sakaidechō, Kagawa-ken, 762-0031
Novartis Investigative Site
Sapporo, Hokkaido, 060-0061
Novartis Investigative Site
Sapporo, Hokkaido, 062-8618
Novartis Investigative Site
Sayama, Osaka, 589-0022
Novartis Investigative Site
Sendai, Miyagi, 983-8520
Novartis Investigative Site
Setagaya-ku, Tokyo, 158-0097
Novartis Investigative Site
Tachikawa, Tokyo, 190-0013
Novartis Investigative Site
Taitō City, Tokyo, 111-0052
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0014
Novartis Investigative Site
Tsukubo-gun, Okayama-ken, 701-0304
Novartis Investigative Site
Yanagawa, Fukuoka, 832-0059
Novartis Investigative Site
Yokohama, Kanagawa, 231-8682

Other trials in Japan

United States38 sites

Novartis Investigative Site
Bangor, Maine, 04401
Novartis Investigative Site
Canton, Ohio, 44718
Novartis Investigative Site
Centennial, Colorado, 80112
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Columbus, Ohio, 43213
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Denver, Colorado, 80230
Novartis Investigative Site
Encinitas, California, 92024
Novartis Investigative Site
Erie, Pennsylvania, 16507
Novartis Investigative Site
Fort Worth, Texas, 76132
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Lake Oswego, Oregon, 97035
Novartis Investigative Site
Lincoln, Rhode Island, 02865
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Medford, Oregon, 97504-8741
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747
Novartis Investigative Site
Oklahoma City, Oklahoma, 73103
Novartis Investigative Site
Omaha, Nebraska, 68130
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Papillion, Nebraska, 68046
Novartis Investigative Site
River Forest, Illinois, 60305
Novartis Investigative Site
Riverside, California, 92506
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
San Jose, California, 95117
Novartis Investigative Site
San Mateo, California, 94401
Novartis Investigative Site
Sarasota, Florida, 34233
Novartis Investigative Site
Savannah, Georgia, 31406
Novartis Investigative Site
Scottsdale, Arizona, 85251
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigative Site
South Burlington, Vermont, 05403
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Stockton, California, 95207
Novartis Investigative Site
Waco, Texas, 76712
Novartis Investigative Site
Warrensburg, Missouri, 64093
Novartis Investigative Site
Wheaton, Maryland, 20902

Other trials in United States

Argentina13 sites

Novartis Investigative Site
Buenos Aires, C1115AAB
Novartis Investigative Site
Buenos Aires, C1125ABE
Novartis Investigative Site
CABA, Buenos Aires, B8000XAV
Novartis Investigative Site
CABA, Buenos Aires, C1122AAK
Novartis Investigative Site
CABA, Buenos Aires, C1186ACB
Novartis Investigative Site
CABA, Buenos Aires, C1425BEN
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600
Novartis Investigative Site
Mendoza, 5500
Novartis Investigative Site
Quilmes, Buenos Aires, B1878FNR
Novartis Investigative Site
San Juan Bautista, Buenos Aires, B2705XAE
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Novartis Investigative Site
Santa Fe, Rosario, S2000DBS
Novartis Investigative Site
Santa Fe, S3000FIL

Other trials in Argentina

India12 sites

Novartis Investigative Site
Ahmedabad, Gujarat, 380007
Novartis Investigative Site
Bangalore, Karnataka, 560 010
Novartis Investigative Site
Chennai, Tamil Nadu, 600 006
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641004
Novartis Investigative Site
Indore, Madhya Pradesh, 452001
Novartis Investigative Site
Jaipur, Rajasthan, 302017
Novartis Investigative Site
Ludhiana, Punjab, 141001
Novartis Investigative Site
Mysore, Karnataka, 570004
Novartis Investigative Site
Nagpur, Maharashtra, 440 012
Novartis Investigative Site
Nagpur - Maharashtra, India, 440012
Novartis Investigative Site
Panjim, Goa, 403 002
Novartis Investigative Site
Pune, Maharashtra, 411 014

Other trials in India

Russia10 sites

Novartis Investigative Site
Barnaul, 656024
Novartis Investigative Site
Barnaul, 656045
Novartis Investigative Site
Chelyabinsk, 454021
Novartis Investigative Site
Chelyabinsk, 454047
Novartis Investigative Site
Moscow, 119992
Novartis Investigative Site
Moscow, 125315
Novartis Investigative Site
Ryazan, 390026
Novartis Investigative Site
Saint Petersburg, 193231
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Yaroslavl, 150003

Other trials in Russia

Romania9 sites

Novartis Investigative Site
Arad, 310013
Novartis Investigative Site
Arad, 310086
Novartis Investigative Site
Bucharest, District 1, 10457
Novartis Investigative Site
Bucharest, District 1, 11475
Novartis Investigative Site
Bucharest, District 3, 030317
Novartis Investigative Site
Bucharest, 050159
Novartis Investigative Site
Craiova, Dolj, 200515
Novartis Investigative Site
Deva, 330162
Novartis Investigative Site
Iași, Jud. Iasi, 700115

Other trials in Romania

South Africa9 sites

Novartis Investigative Site
Benoni
Novartis Investigative Site
Cape Town, 7531
Novartis Investigative Site
Cape Town, 7925
Novartis Investigative Site
Durban, 4001
Novartis Investigative Site
eManzimtoti, 4126
Novartis Investigative Site
Gatesville, 7764
Novartis Investigative Site
Port Elizabeth, 6001
Novartis Investigative Site
Pretoria, 0001
Novartis Investigative Site
Pretoria, 0181

Other trials in South Africa

France8 sites

Novartis Investigative Site
Ferolles-Attily, France, 77150
Novartis Investigative Site
Lyon, 69317
Novartis Investigative Site
Montpellier, 34059
Novartis Investigative Site
Paris, 75006
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Strasbourg, 67091
Novartis Investigative Site
Tarbes, 65013

Other trials in France

Hungary8 sites

Novartis Investigative Site
Balassagyarmat, 2660
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Deszk, 6772
Novartis Investigative Site
Győr, 9024
Novartis Investigative Site
Mosonmagyaróvár, 9200
Novartis Investigative Site
Nyíregyháza, 4400
Novartis Investigative Site
Százhalombatta, 2440
Novartis Investigative Site
Törökbálint, 2045

Other trials in Hungary

Mexico8 sites

Novartis Investigative Site
Guadalajara, Jalisco, 44130
Novartis Investigative Site
Guadalajara, Jalisco, 44280
Novartis Investigative Site
Mexicali, Estado de Baja California, 21100
Novartis Investigative Site
Mexico City, Mexico City, 03020
Novartis Investigative Site
Mexico City, Mexico City, 14050
Novartis Investigative Site
Mexico City, Mexico City, 14080
Novartis Investigative Site
Monterrey, Nuevo León, 64718
Novartis Investigative Site
Zapopan, Jalisco, 45040

Other trials in Mexico

Peru6 sites

Novartis Investigative Site
Jesus Maria, Lima region, 11
Novartis Investigative Site
Lima Cercado, Lima region, 01
Novartis Investigative Site
Miraflores, Lima region, 18
Novartis Investigative Site
San Borja, Lima region, 41
Novartis Investigative Site
San Isidro, Lima region, 27
Novartis Investigative Site
Santiago de Surco, Lima region, 33

Other trials in Peru

Turkey (Türkiye)6 sites

Novartis Investigative Site
Fatih / Istanbul, 34098
Novartis Investigative Site
Istanbul, 34093
Novartis Investigative Site
Istanbul, 34854
Novartis Investigative Site
Izmir, 35040
Novartis Investigative Site
Mersin, 33079
Novartis Investigative Site
Yenisehir/Izmir, 35110

Other trials in Turkey (Türkiye)

Austria5 sites

Novartis Investigative Site
Feldbach, 8330
Novartis Investigative Site
Grieskirchen, 4710
Novartis Investigative Site
Linz, 4020
Novartis Investigative Site
Thalheim bei Wels, 4600
Novartis Investigative Site
Vienna, 1210

Other trials in Austria

Bulgaria5 sites

Novartis Investigative Site
Plovdiv, 400
Novartis Investigative Site
Rousse, 7002
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Sofia, 1463
Novartis Investigative Site
Varna, 9020

Other trials in Bulgaria

Colombia5 sites

Novartis Investigative Site
Armenia
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogota, Cundinamarca
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Medellín

Other trials in Colombia

Canada3 sites

Novartis Investigative Site
Ottawa, Ontario, K1Y 4G2
Novartis Investigative Site
Québec, Quebec, GIV 4M6
Novartis Investigative Site
Toronto, Ontario, M4V 1R2

Other trials in Canada

Greece3 sites

Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Heraklion - Crete, GR, 711 10
Novartis Investigative Site
Thessaloniki, GR, 570 10

Other trials in Greece

Guatemala3 sites

Novartis Investigative Site
Antigua Guatemala
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 01015

Other trials in Guatemala

Italy3 sites

Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Pisa, PI, 56124

Other trials in Italy

United Kingdom3 sites

Novartis Investigative Site
Bradford, BD9 6RJ
Novartis Investigative Site
Glasgow - Scotland, G12 OYN
Novartis Investigative Site
Newcastle upon Tyne, Newcastle, NE7 7DN

Other trials in United Kingdom

Netherlands2 sites

Novartis Investigative Site
Almelo, 7609 PP
Novartis Investigative Site
Harderwijk, 3840 AC

Other trials in Netherlands

Poland2 sites

Novartis Investigative Site
Katowice, 40-752
Novartis Investigative Site
Krakow, 31-159

Other trials in Poland

About this study

Official title: A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy.

Conditions: Asthma
Being tested: QAW039, Montelukast, Placebo
Keywords: Asthma, QAW039
Medical subject headings: Asthma

What participants receive

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

QAW039Drug
QAW039 po
MontelukastDrug
Montelukast 10 mg po
PlaceboDrug
Placebo

Study groups in NCT01437735
Study group	Role	What they receive
QAW039 po dose 1	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 2	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 3	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 4	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 5	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 6	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 7	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 8	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 9	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 10	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 11	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 12	Experimental	Not described Receives: Drug: QAW039
QAW039 po dose 13	Experimental	Not described Receives: Drug: QAW039
Montelukast po 10 mg	Active comparator	Comparator leukotriene receptor antagonist (LRTA) Receives: Drug: Montelukast
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12
Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.
Measured: Baseline and week 12

Secondary outcomes (7)

Change in Asthma Control Questionnaire (ACQ) score from baseline to week 12
The Asthma Control Questionnaire (ACQ) is a validated questionnaire consisting of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 assessing the patients Forced Expiratory Volume in 1 second (FEV1) result against the predicted result for a person of similar age and stature. Each item is graded on a scale of 0-6, and a mean score of 1.5 or greater is considered to demonstrate inadequate asthma control in this trial. The minimal important difference that is considered clinically important is a change of 0.5 in the mean score.
Measured: Baseline and week 12
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to weeks 2, 4 and 8.
Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the measurement is taken 24 hours after the morning dose on the previous day.
Measured: Baseline, week 2, week 4 and week 8
Change in the Asthma Control Questionnaire (ACQ) score from baseline to weeks 2, 4 and 8.
The Asthma Control Questionnaire (ACQ) is a validated questionnaire consisting of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 assessing the patients Forced Expiratory Volume in 1 second (FEV1) result against the predicted result for a person of similar age and stature. Each item is graded on a scale of 0-6, and a mean score of 1.5 or greater is considered to demonstrate inadequate asthma control in this trial. The minimal important difference that is considered clinically important is a change of 0.5 in the mean score.
Measured: Baseline, week 2, week 4 and week 8
Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment.
Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the measurement is taken 24 hours after the morning dose on the previous day.
Measured: Baseline and week 12
Comparison of vital signs, ECG, laboratory tests and adverse events across QAW039 doses and placebo.
Comparisons of vital signs (i.e. systolic and diastolic blood pressure, pulse rate), ECG (e.g. quantitative assessments - heart rate, QTcF, PRS, PR intervals), laboratory tests (haematology, clinical chemistry and urinalysis) and adverse events across QAW039 doses and placebo.
Measured: Baseline and week 12
Comparison of efficacy of QAW039 with that of active comparator as an add-on therapy to Inhaled Corticosteroids (ICS)
Forced Expiratory Volume in 1 second (FEV1) measurement taken 24 hours after the morning dose on the previous day. The Asthma Control Questionnaire (ACQ)consisting of 7 items: 5 on system assessment, 1 on rescue bronchodilator use and 1 assessing the patients for FEV1 result against the predicted result for a person of similar age and stature. Each item is graded on a scale of 0-6, and a mean score of 1.5 or greater is considered to demonstrate inadequate asthma control in this trial. The minimal important difference that is considered clinically important is a change of 0.5 in the mean score.
Measured: Baseline and week 12
Assess the effect of QAW039 on asthma symptoms as measured by asthma control diary.
The asthma control diary mimics the Asthma Control Questionnaire (ACQ), but is recorded daily by the patient, rather than at each visit. As for the ACQ, the ACD consists of 7 questions.
Measured: Baseline and week 12

Timeline

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

Aug 2011Nov 2013

First posted21 Sep 2011 (estimated)
Study startAug 2011
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,043 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01437735
Sponsor's protocol ID: CQAW039A2206
Other IDs: 2011-001062-18
Status last verified: Nov 2020
First submitted: 14 Sep 2011
Last updated: 19 Dec 2020
Results posted: No
Data monitoring committee: No

Publications

Bateman ED, Guerreros AG, Brockhaus F, Holzhauer B, Pethe A, Kay RA, Townley RG. Fevipiprant, an oral prostaglandin DP2 receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Eur Respir J. 2017 Aug 24;50(2):1700670. doi: 10.1183/13993003.00670-2017. Print 2017 Aug.
PubMed 28838980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy.
ClinicalTrials.gov ID: NCT01437735
Acronym / sponsor ID: CQAW039A2206
Conditions: Asthma
Keywords: Asthma, QAW039
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,043 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 21 Sep 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 15

Arm	Type	Receives
QAW039 po dose 1	Experimental	Drug: QAW039
QAW039 po dose 2	Experimental	Drug: QAW039
QAW039 po dose 3	Experimental	Drug: QAW039
QAW039 po dose 4	Experimental	Drug: QAW039
QAW039 po dose 5	Experimental	Drug: QAW039
QAW039 po dose 6	Experimental	Drug: QAW039
QAW039 po dose 7	Experimental	Drug: QAW039
QAW039 po dose 8	Experimental	Drug: QAW039
QAW039 po dose 9	Experimental	Drug: QAW039
QAW039 po dose 10	Experimental	Drug: QAW039
QAW039 po dose 11	Experimental	Drug: QAW039
QAW039 po dose 12	Experimental	Drug: QAW039
QAW039 po dose 13	Experimental	Drug: QAW039
Montelukast po 10 mg	Active comparator	Drug: MontelukastComparator leukotriene receptor antagonist (LRTA)
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy.
Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value of 40% to 80% of individual predicted value.
Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study.
Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year.
An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization.

Key exclusion criteria (6 listed)

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.).
Acute illness other than asthma at the start of the study
History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma.
Patients who have had a respiratory tract infection within 4 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QAW039QAW039 po	Drug	QAW039 po dose 1, QAW039 po dose 10, QAW039 po dose 11, QAW039 po dose 12, QAW039 po dose 13, QAW039 po dose 2, QAW039 po dose 3, QAW039 po dose 4, QAW039 po dose 5, QAW039 po dose 6, QAW039 po dose 7, QAW039 po dose 8, QAW039 po dose 9
MontelukastMontelukast 10 mg po	Drug	Montelukast po 10 mg
PlaceboPlacebo	Drug	Placebo

Primary outcome

Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12
Time frame: Baseline and week 12
Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.

7 secondary outcomes

Change in Asthma Control Questionnaire (ACQ) score from baseline to week 12
Time frame: Baseline and week 12
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to weeks 2, 4 and 8.
Time frame: Baseline, week 2, week 4 and week 8
Change in the Asthma Control Questionnaire (ACQ) score from baseline to weeks 2, 4 and 8.
Time frame: Baseline, week 2, week 4 and week 8
Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment.
Time frame: Baseline and week 12
Comparison of vital signs, ECG, laboratory tests and adverse events across QAW039 doses and placebo.
Time frame: Baseline and week 12
Comparison of efficacy of QAW039 with that of active comparator as an add-on therapy to Inhaled Corticosteroids (ICS)
Time frame: Baseline and week 12
Assess the effect of QAW039 on asthma symptoms as measured by asthma control diary.
Time frame: Baseline and week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
Derived from this study: PubMed 28838980Bateman ED, Guerreros AG, Brockhaus F, Holzhauer B, Pethe A, Kay RA, Townley RG. Fevipiprant, an oral prostaglandin DP2 receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Eur Respir J. 2017 Aug 24;50(2):1700670. doi: 10.1183/13993003.00670-2017. Print 2017 Aug.
Results for CQAW039A2206 from the Novartis Clinical Trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

206 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QAW039 and Montelukast in people with Asthma, run by Novartis Pharmaceuticals at 206 sites in 22 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 5 inclusion and 6 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 206 sites in Japan, United States, Argentina, India, Russia and 17 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12 (time frame: Baseline and week 12). 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 NCT01437735, which also lists 1 linked publication.

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 19 Dec 2020.