Dose Finding Study for QAW039 in Asthma

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.

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: QAW039; Drug: Montelukast

• Study Type: Interventional
• Enrollment (Actual): 1043
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1115AAB
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1125ABE
    • Novartis Investigative Site
  • Mendoza, Argentina, 5500
    • Novartis Investigative Site
  • Santa Fe, Argentina, S3000FIL
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1122AAK
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1425BEN
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, B8000XAV
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1186ACB
      • Novartis Investigative Site
    • Florencio Varela, Buenos Aires, Argentina, B2705XAE
      • Novartis Investigative Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Novartis Investigative Site
    • Quilmes, Buenos Aires, Argentina, B1878FNR
      • Novartis Investigative Site
  • Rosario
    • Santa Fe, Rosario, Argentina, S2000DBS
      • Novartis Investigative Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Novartis Investigative Site
• Austria
  • Feldbach, Austria, 8330
    • Novartis Investigative Site
  • Grieskirchen, Austria, 4710
    • Novartis Investigative Site
  • Linz, Austria, 4020
    • Novartis Investigative Site
  • Thalheim bei Wels, Austria, 4600
    • Novartis Investigative Site
  • Vienna, Austria, 1210
    • Novartis Investigative Site
• Bulgaria
  • Plovdiv, Bulgaria, 400
    • Novartis Investigative Site
  • Ruse, Bulgaria, 7002
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1431
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1463
    • Novartis Investigative Site
  • Varna, Bulgaria, 9020
    • Novartis Investigative Site
• Canada
  • Quebec, Canada, GIV 4M6
    • Novartis Investigative Site
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4G2
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M4V 1R2
      • Novartis Investigative Site
• Colombia
  • Armenia, Colombia
    • Novartis Investigative Site
  • Barranquilla, Colombia
    • Novartis Investigative Site
  • Bogotá, Colombia
    • Novartis Investigative Site
  • Medellín, Colombia
    • Novartis Investigative Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Novartis Investigative Site
• France
  • Ferolles-Attily, France, 77150
    • Novartis Investigative Site
  • Lyon cedex 04, France, 69317
    • Novartis Investigative Site
  • Montpellier, France, 34059
    • Novartis Investigative Site
  • Paris, France, 75006
    • Novartis Investigative Site
  • Pessac, France, 33604
    • Novartis Investigative Site
  • Reims, France, 51092
    • Novartis Investigative Site
  • Strasbourg Cedex, France, 67091
    • Novartis Investigative Site
  • Tarbes Cedex, France, 65013
    • Novartis Investigative Site
• Greece
  • GR
    • Athens, GR, Greece, 115 27
      • Novartis Investigative Site
    • Heraklion - Crete, GR, Greece, 711 10
      • Novartis Investigative Site
    • Thessaloniki, GR, Greece, 570 10
      • Novartis Investigative Site
• Guatemala
  • Antigua Guatemala, Guatemala
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01015
    • Novartis Investigative Site
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Novartis Investigative Site
  • Debrecen, Hungary, 4032
    • Novartis Investigative Site
  • Deszk, Hungary, 6772
    • Novartis Investigative Site
  • Gyor, Hungary, 9024
    • Novartis Investigative Site
  • Mosonmagyarovar, Hungary, 9200
    • Novartis Investigative Site
  • Nyiregyhaza, Hungary, 4400
    • Novartis Investigative Site
  • Százhalombatta, Hungary, 2440
    • Novartis Investigative Site
  • Torokbalint, Hungary, 2045
    • Novartis Investigative Site
• India
  • Nagpur - Maharashtra, India, 440012
    • Novartis Investigative Site
  • Goa
    • Panjim, Goa, India, 403 002
      • Novartis Investigative Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380007
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 010
      • Novartis Investigative Site
    • Mysore, Karnataka, India, 570004
      • Novartis Investigative Site
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452001
      • Novartis Investigative Site
  • Maharashtra
    • Nagpur, Maharashtra, India, 440 012
      • Novartis Investigative Site
    • Pune, Maharashtra, India, 411 014
      • Novartis Investigative Site
  • Punjab
    • Ludhiana, Punjab, India, 141001
      • Novartis Investigative Site
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Novartis Investigative Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 006
      • Novartis Investigative Site
    • Coimbatore, Tamil Nadu, India, 641004
      • Novartis Investigative Site
• Italy
  • FI
    • Firenze, FI, Italy, 50134
      • Novartis Investigative Site
  • PI
    • Pisa, PI, Italy, 56124
      • Novartis Investigative Site
  • PR
    • Parma, PR, Italy, 43100
      • Novartis Investigative Site
• Japan
  • Fukuoka, Japan, 811-1394
    • Novartis Investigative Site
  • Hiroshima, Japan, 732-0052
    • Novartis Investigative Site
  • Kochi, Japan, 780-8077
    • Novartis Investigative Site
  • Kyoto, Japan, 612-0026
    • Novartis Investigative Site
  • Osaka, Japan, 560-0005
    • Novartis Investigative Site
  • Aichi
    • Nishio-city, Aichi, Japan, 445-8510
      • Novartis Investigative Site
  • Fukuoka
    • Fukuoka-city, Fukuoka, Japan, 819-8555
      • Novartis Investigative Site
    • Kasuga-city, Fukuoka, Japan, 816-0813
      • Novartis Investigative Site
    • Kitakyushu, Fukuoka, Japan, 802-0083
      • Novartis Investigative Site
    • Kitakyushu, Fukuoka, Japan, 820-0052
      • Novartis Investigative Site
    • Yanagawa, Fukuoka, Japan, 832-0059
      • Novartis Investigative Site
  • Gifu
    • Mizunami-city, Gifu, Japan, 509-6134
      • Novartis Investigative Site
  • Hiroshima
    • Hatsukaichi-city, Hiroshima, Japan, 739-0402
      • Novartis Investigative Site
  • Hokkaido
    • Asahikawa-city, Hokkaido, Japan, 070-8644
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 062-8618
      • Novartis Investigative Site
    • Sapporo-city, Hokkaido, Japan, 060-0061
      • Novartis Investigative Site
  • Hyogo
    • Himeji-city, Hyogo, Japan, 672-8064
      • Novartis Investigative Site
  • Ibaraki
    • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
      • Novartis Investigative Site
    • Hitachi-city, Ibaraki, Japan, 317-0077
      • Novartis Investigative Site
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-0853
      • Novartis Investigative Site
  • Kagawa
    • Sakaide, Kagawa, Japan, 762-0031
      • Novartis Investigative Site
  • Kanagawa
    • Kawasaki-city, Kanagawa, Japan, 210-0852
      • Novartis Investigative Site
    • Sagamihara-city, Kanagawa, Japan, 228-8522
      • Novartis Investigative Site
    • Yokohama-city, Kanagawa, Japan, 231-8682
      • Novartis Investigative Site
  • Miyagi
    • Sendai-city, Miyagi, Japan, 983-8520
      • Novartis Investigative Site
  • Okayama
    • Kurashiki-city, Okayama, Japan, 712-8064
      • Novartis Investigative Site
    • Tsukubo-gun, Okayama, Japan, 701-0304
      • Novartis Investigative Site
  • Osaka
    • Habikino city, Osaka, Japan, 583-8588
      • Novartis Investigative Site
    • Kishiwada, Osaka, Japan, 596-8501
      • Novartis Investigative Site
    • Osakasayama, Osaka, Japan, 589-0022
      • Novartis Investigative Site
  • Saitama
    • Koshigaya-city, Saitama, Japan, 343-0851
      • Novartis Investigative Site
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 430-8525
      • Novartis Investigative Site
    • Hamamatsu, Shizuoka, Japan, 434-8511
      • Novartis Investigative Site
    • Hamamatsu-city, Shizuoka, Japan, 430-8558
      • Novartis Investigative Site
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 1020083
      • Novartis Investigative Site
    • Chuo-ku, Tokyo, Japan, 103-0028
      • Novartis Investigative Site
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Novartis Investigative Site
    • Edogawa-ku, Tokyo, Japan, 134-0083
      • Novartis Investigative Site
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Novartis Investigative Site
    • Kiyose-city, Tokyo, Japan, 204-8585
      • Novartis Investigative Site
    • Minato-ku, Tokyo, Japan, 108-8606
      • Novartis Investigative Site
    • Setagaya-ku, Tokyo, Japan, 158-0097
      • Novartis Investigative Site
    • Tachikawa, Tokyo, Japan, 190-0013
      • Novartis Investigative Site
    • Taito, Tokyo, Japan, 111-0052
      • Novartis Investigative Site
    • Toshima-ku, Tokyo, Japan, 171-0014
      • Novartis Investigative Site
• Mexico
  • Baja California
    • Mexicali, Baja California, Mexico, 21100
      • Novartis Investigative Site
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 14050
      • Novartis Investigative Site
    • Mexico, Distrito Federal, Mexico, 03020
      • Novartis Investigative Site
    • México, Distrito Federal, Mexico, 14080
      • Novartis Investigative Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Novartis Investigative Site
    • Guadalajara, Jalisco, Mexico, 44280
      • Novartis Investigative Site
    • Zapopan, Jalisco, Mexico, 45040
      • Novartis Investigative Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64718
      • Novartis Investigative Site
• Netherlands
  • Almelo, Netherlands, 7609 PP
    • Novartis Investigative Site
  • Harderwijk, Netherlands, 3840 AC
    • Novartis Investigative Site
• Peru
  • Lima
    • Cercado De Lima, Lima, Peru, 01
      • Novartis Investigative Site
    • Jesus Maria, Lima, Peru, 11
      • Novartis Investigative Site
    • Miraflores, Lima, Peru, 18
      • Novartis Investigative Site
    • San Borja, Lima, Peru, 41
      • Novartis Investigative Site
    • San Isidro, Lima, Peru, 27
      • Novartis Investigative Site
    • Santiago de Surco, Lima, Peru, 33
      • Novartis Investigative Site
• Poland
  • Katowice, Poland, 40-752
    • Novartis Investigative Site
  • Krakow, Poland, 31-159
    • Novartis Investigative Site
• Romania
  • Arad, Romania, 310013
    • Novartis Investigative Site
  • Arad, Romania, 310086
    • Novartis Investigative Site
  • Bucharest, Romania, 050159
    • Novartis Investigative Site
  • Deva, Romania, 330162
    • Novartis Investigative Site
  • District 1
    • Bucharest, District 1, Romania, 10457
      • Novartis Investigative Site
    • Bucharest, District 1, Romania, 11475
      • Novartis Investigative Site
  • District 3
    • Bucharest, District 3, Romania, 030317
      • Novartis Investigative Site
  • Dolj
    • Craiova, Dolj, Romania, 200515
      • Novartis Investigative Site
  • Jud. Iasi
    • Iasi, Jud. Iasi, Romania, 700115
      • Novartis Investigative Site
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • Novartis Investigative Site
  • Barnaul, Russian Federation, 656024
    • Novartis Investigative Site
  • Chelyabinsk, Russian Federation, 454021
    • Novartis Investigative Site
  • Chelyabinsk, Russian Federation, 454047
    • Novartis Investigative Site
  • Moscow, Russian Federation, 119992
    • Novartis Investigative Site
  • Moscow, Russian Federation, 125315
    • Novartis Investigative Site
  • Ryazan, Russian Federation, 390026
    • Novartis Investigative Site
  • St. Petersburg, Russian Federation, 194354
    • Novartis Investigative Site
  • St.-Petersburg, Russian Federation, 193231
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• South Africa
  • Amanzimtoti, South Africa, 4126
    • Novartis Investigative Site
  • Benoni, South Africa
    • Novartis Investigative Site
  • Cape Town, South Africa, 7531
    • Novartis Investigative Site
  • Cape Town, South Africa, 7925
    • Novartis Investigative Site
  • Durban, South Africa, 4001
    • Novartis Investigative Site
  • Gatesville, South Africa, 7764
    • Novartis Investigative Site
  • Port Elizabeth, South Africa, 6001
    • Novartis Investigative Site
  • Pretoria, South Africa, 0181
    • Novartis Investigative Site
  • Pretoria, South Africa, 0001
    • Novartis Investigative Site
• Turkey
  • Fatih / Istanbul, Turkey, 34098
    • Novartis Investigative Site
  • Istanbul, Turkey, 34093
    • Novartis Investigative Site
  • Istanbul, Turkey, 34854
    • Novartis Investigative Site
  • Izmir, Turkey, 35040
    • Novartis Investigative Site
  • Mersin, Turkey, 33079
    • Novartis Investigative Site
  • Yenisehir/Izmir, Turkey, 35110
    • Novartis Investigative Site
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Novartis Investigative Site
  • Glasgow - Scotland, United Kingdom, G12 OYN
    • Novartis Investigative Site
  • Newcastle
    • Newcastle Upon Tyne, Newcastle, United Kingdom, NE7 7DN
      • Novartis Investigative Site
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Novartis Investigative Site
  • California
    • Encinitas, California, United States, 92024
      • Novartis Investigative Site
    • Huntington Beach, California, United States, 92647
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90048
      • Novartis Investigative Site
    • Orange, California, United States, 92868
      • Novartis Investigative Site
    • Riverside, California, United States, 92506
      • Novartis Investigative Site
    • San Diego, California, United States, 92123
      • Novartis Investigative Site
    • San Diego, California, United States, 92120
      • Novartis Investigative Site
    • San Jose, California, United States, 95117
      • Novartis Investigative Site
    • San Mateo, California, United States, 94401
      • Novartis Investigative Site
    • Stockton, California, United States, 95207
      • Novartis Investigative Site
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Novartis Investigative Site
    • Denver, Colorado, United States, 80230
      • Novartis Investigative Site
  • Florida
    • Sarasota, Florida, United States, 34233
      • Novartis Investigative Site
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Novartis Investigative Site
  • Illinois
    • River Forest, Illinois, United States, 60305
      • Novartis Investigative Site
  • Maine
    • Bangor, Maine, United States, 04401
      • Novartis Investigative Site
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Novartis Investigative Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Novartis Investigative Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Novartis Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Novartis Investigative Site
    • Warrensburg, Missouri, United States, 64093
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Novartis Investigative Site
    • Omaha, Nebraska, United States, 68130
      • Novartis Investigative Site
    • Papillion, Nebraska, United States, 68046
      • Novartis Investigative Site
  • New Jersey
    • Skillman, New Jersey, United States, 08558
      • Novartis Investigative Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Novartis Investigative Site
    • Columbus, Ohio, United States, 43213
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Novartis Investigative Site
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Novartis Investigative Site
    • Medford, Oregon, United States, 97504-8741
      • Novartis Investigative Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Novartis Investigative Site
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75231
      • Novartis Investigative Site
    • Fort Worth, Texas, United States, 76132
      • Novartis Investigative Site
    • Waco, Texas, United States, 76712
      • Novartis Investigative Site
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo
EXPERIMENTAL: QAW039 po dose 1	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 2	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 3	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 4	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 5	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 6	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 7	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 8	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 9	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 10	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 11	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 12	Drug: QAW039; QAW039 po
EXPERIMENTAL: QAW039 po dose 13	Drug: QAW039; QAW039 po
ACTIVE_COMPARATOR: Montelukast po 10 mg; Comparator leukotriene receptor antagonist (LRTA)	Drug: Montelukast; Montelukast 10 mg po

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General 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.

Helpful Links

• Results for CQAW039A2206 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (ESTIMATE): September 21, 2011

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; QAW039
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: CQAW039A2206; 2011-001062-18 (EUDRACT_NUMBER)