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NCT01437735 Clinical Trial

Dose Finding Study for QAW039 in Asthma

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01437735
Other study ID # CQAW039A2206
Secondary ID 2011-001062-18
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2011
Est. completion date November 2013

Study information
Verified date November 2020
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

Recruitment information / eligibility
Status Completed
Enrollment 1043
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• QAW039
QAW039 po
• Montelukast
Montelukast 10 mg po
• Placebo
Placebo

Locations
Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Florencio Varela Buenos Aires
Argentina Novartis Investigative Site Mar del Plata Buenos Aires
Argentina Novartis Investigative Site Mendoza
Argentina Novartis Investigative Site Quilmes Buenos Aires
Argentina Novartis Investigative Site San Miguel de Tucuman Tucuman
Argentina Novartis Investigative Site Santa Fe Rosario
Argentina Novartis Investigative Site Santa Fe
Austria Novartis Investigative Site Feldbach
Austria Novartis Investigative Site Grieskirchen
Austria Novartis Investigative Site Linz
Austria Novartis Investigative Site Thalheim bei Wels
Austria Novartis Investigative Site Vienna
Bulgaria Novartis Investigative Site Plovdiv
Bulgaria Novartis Investigative Site Ruse
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Varna
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Toronto Ontario
Colombia Novartis Investigative Site Armenia
Colombia Novartis Investigative Site Barranquilla
Colombia Novartis Investigative Site Bogota Cundinamarca
Colombia Novartis Investigative Site Bogotá
Colombia Novartis Investigative Site Medellín
France Novartis Investigative Site Ferolles-Attily
France Novartis Investigative Site Lyon cedex 04
France Novartis Investigative Site Montpellier
France Novartis Investigative Site Paris
France Novartis Investigative Site Pessac
France Novartis Investigative Site Reims
France Novartis Investigative Site Strasbourg Cedex
France Novartis Investigative Site Tarbes Cedex
Greece Novartis Investigative Site Athens GR
Greece Novartis Investigative Site Heraklion - Crete GR
Greece Novartis Investigative Site Thessaloniki GR
Guatemala Novartis Investigative Site Antigua Guatemala
Guatemala Novartis Investigative Site Guatemala City
Guatemala Novartis Investigative Site Guatemala City
Hungary Novartis Investigative Site Balassagyarmat
Hungary Novartis Investigative Site Debrecen
Hungary Novartis Investigative Site Deszk
Hungary Novartis Investigative Site Gyor
Hungary Novartis Investigative Site Mosonmagyarovar
Hungary Novartis Investigative Site Nyiregyhaza
Hungary Novartis Investigative Site Százhalombatta
Hungary Novartis Investigative Site Torokbalint
India Novartis Investigative Site Ahmedabad Gujarat
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Chennai Tamil Nadu
India Novartis Investigative Site Coimbatore Tamil Nadu
India Novartis Investigative Site Indore Madhya Pradesh
India Novartis Investigative Site Jaipur Rajasthan
India Novartis Investigative Site Ludhiana Punjab
India Novartis Investigative Site Mysore Karnataka
India Novartis Investigative Site Nagpur Maharashtra
India Novartis Investigative Site Nagpur - Maharashtra
India Novartis Investigative Site Panjim Goa
India Novartis Investigative Site Pune Maharashtra
Italy Novartis Investigative Site Firenze FI
Italy Novartis Investigative Site Parma PR
Italy Novartis Investigative Site Pisa PI
Japan Novartis Investigative Site Asahikawa-city Hokkaido
Japan Novartis Investigative Site Chiyoda-ku Tokyo
Japan Novartis Investigative Site Chuo-ku Tokyo
Japan Novartis Investigative Site Chuo-ku Tokyo
Japan Novartis Investigative Site Edogawa-ku Tokyo
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Fukuoka-city Fukuoka
Japan Novartis Investigative Site Habikino city Osaka
Japan Novartis Investigative Site Hamamatsu Shizuoka
Japan Novartis Investigative Site Hamamatsu Shizuoka
Japan Novartis Investigative Site Hamamatsu-city Shizuoka
Japan Novartis Investigative Site Hatsukaichi-city Hiroshima
Japan Novartis Investigative Site Higashiibaraki-gun Ibaraki
Japan Novartis Investigative Site Himeji-city Hyogo
Japan Novartis Investigative Site Hiroshima
Japan Novartis Investigative Site Hitachi-city Ibaraki
Japan Novartis Investigative Site Itabashi-ku Tokyo
Japan Novartis Investigative Site Kanazawa Ishikawa
Japan Novartis Investigative Site Kasuga-city Fukuoka
Japan Novartis Investigative Site Kawasaki-city Kanagawa
Japan Novartis Investigative Site Kishiwada Osaka
Japan Novartis Investigative Site Kitakyushu Fukuoka
Japan Novartis Investigative Site Kitakyushu Fukuoka
Japan Novartis Investigative Site Kiyose-city Tokyo
Japan Novartis Investigative Site Kochi
Japan Novartis Investigative Site Koshigaya-city Saitama
Japan Novartis Investigative Site Kurashiki-city Okayama
Japan Novartis Investigative Site Kyoto
Japan Novartis Investigative Site Minato-ku Tokyo
Japan Novartis Investigative Site Mizunami-city Gifu
Japan Novartis Investigative Site Nishio-city Aichi
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Osakasayama Osaka
Japan Novartis Investigative Site Sagamihara-city Kanagawa
Japan Novartis Investigative Site Sakaide Kagawa
Japan Novartis Investigative Site Sapporo Hokkaido
Japan Novartis Investigative Site Sapporo-city Hokkaido
Japan Novartis Investigative Site Sendai-city Miyagi
Japan Novartis Investigative Site Setagaya-ku Tokyo
Japan Novartis Investigative Site Tachikawa Tokyo
Japan Novartis Investigative Site Taito Tokyo
Japan Novartis Investigative Site Toshima-ku Tokyo
Japan Novartis Investigative Site Tsukubo-gun Okayama
Japan Novartis Investigative Site Yanagawa Fukuoka
Japan Novartis Investigative Site Yokohama-city Kanagawa
Mexico Novartis Investigative Site Guadalajara Jalisco
Mexico Novartis Investigative Site Guadalajara Jalisco
Mexico Novartis Investigative Site Mexicali Baja California
Mexico Novartis Investigative Site Mexico Distrito Federal
Mexico Novartis Investigative Site Mexico Distrito Federal
Mexico Novartis Investigative Site México Distrito Federal
Mexico Novartis Investigative Site Monterrey Nuevo León
Mexico Novartis Investigative Site Zapopan Jalisco
Netherlands Novartis Investigative Site Almelo
Netherlands Novartis Investigative Site Harderwijk
Peru Novartis Investigative Site Cercado De Lima Lima
Peru Novartis Investigative Site Jesus Maria Lima
Peru Novartis Investigative Site Miraflores Lima
Peru Novartis Investigative Site San Borja Lima
Peru Novartis Investigative Site San Isidro Lima
Peru Novartis Investigative Site Santiago de Surco Lima
Poland Novartis Investigative Site Katowice
Poland Novartis Investigative Site Krakow
Romania Novartis Investigative Site Arad
Romania Novartis Investigative Site Arad
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Bucharest District 1
Romania Novartis Investigative Site Bucharest District 1
Romania Novartis Investigative Site Bucharest District 3
Romania Novartis Investigative Site Craiova Dolj
Romania Novartis Investigative Site Deva
Romania Novartis Investigative Site Iasi Jud. Iasi
Russian Federation Novartis Investigative Site Barnaul
Russian Federation Novartis Investigative Site Barnaul
Russian Federation Novartis Investigative Site Chelyabinsk
Russian Federation Novartis Investigative Site Chelyabinsk
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Ryazan
Russian Federation Novartis Investigative Site St. Petersburg
Russian Federation Novartis Investigative Site St.-Petersburg
Russian Federation Novartis Investigative Site Yaroslavl
South Africa Novartis Investigative Site Amanzimtoti
South Africa Novartis Investigative Site Benoni
South Africa Novartis Investigative Site Cape Town
South Africa Novartis Investigative Site Cape Town
South Africa Novartis Investigative Site Durban
South Africa Novartis Investigative Site Gatesville
South Africa Novartis Investigative Site Port Elizabeth
South Africa Novartis Investigative Site Pretoria
South Africa Novartis Investigative Site Pretoria
Turkey Novartis Investigative Site Fatih / Istanbul
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Mersin
Turkey Novartis Investigative Site Yenisehir/Izmir
United Kingdom Novartis Investigative Site Bradford
United Kingdom Novartis Investigative Site Glasgow - Scotland
United Kingdom Novartis Investigative Site Newcastle Upon Tyne Newcastle
United States Novartis Investigative Site Bangor Maine
United States Novartis Investigative Site Canton Ohio
United States Novartis Investigative Site Centennial Colorado
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Encinitas California
United States Novartis Investigative Site Erie Pennsylvania
United States Novartis Investigative Site Fort Worth Texas
United States Novartis Investigative Site Huntington Beach California
United States Novartis Investigative Site Lake Oswego Oregon
United States Novartis Investigative Site Lincoln Rhode Island
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Medford Oregon
United States Novartis Investigative Site Minneapolis Minnesota
United States Novartis Investigative Site North Dartmouth Massachusetts
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Orange California
United States Novartis Investigative Site Papillion Nebraska
United States Novartis Investigative Site River Forest Illinois
United States Novartis Investigative Site Riverside California
United States Novartis Investigative Site Saint Louis Missouri
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Jose California
United States Novartis Investigative Site San Mateo California
United States Novartis Investigative Site Sarasota Florida
United States Novartis Investigative Site Savannah Georgia
United States Novartis Investigative Site Scottsdale Arizona
United States Novartis Investigative Site Skillman New Jersey
United States Novartis Investigative Site South Burlington Vermont
United States Novartis Investigative Site Stockton California
United States Novartis Investigative Site Waco Texas
United States Novartis Investigative Site Warrensburg Missouri
United States Novartis Investigative Site Wheaton Maryland

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Bulgaria,  Canada,  Colombia,  France,  Greece,  Guatemala,  Hungary,  India,  Italy,  Japan,  Mexico,  Netherlands,  Peru,  Poland,  Romania,  Russian Federation,  South Africa,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline and week 12
Secondary 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. Baseline and week 12
Secondary 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. Baseline, week 2, week 4 and week 8
Secondary 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. Baseline, week 2, week 4 and week 8
Secondary 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. Baseline and week 12
Secondary 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. Baseline and week 12
Secondary 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. Baseline and week 12
Secondary 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. Baseline and week 12
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