Dose Finding Study for QAW039 in Asthma

NCT01437735 | Completed Phase 2

• 2 other identifiers: CQAW039A22062011-001062-18
• Study Type: interventional
• Target: 1,043
• Locations: 22 countries
• Sites: 206

Brief 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.

Conditions

Asthma

Keywords

Asthma; QAW039

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Asthma Control Questionnaire (ACQ) score from baseline to week 12

  Baseline and week 12

• Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to weeks 2, 4 and 8.

  Baseline, week 2, week 4 and week 8

• Change in the Asthma Control Questionnaire (ACQ) score from baseline to weeks 2, 4 and 8.

  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.

  Baseline and week 12

• Comparison of vital signs, ECG, laboratory tests and adverse events across QAW039 doses and placebo.

  Baseline and week 12

Study Arms (15)

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

Comparator leukotriene receptor antagonist (LRTA)

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

QAW039 DRUG

QAW039 po

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

Montelukast DRUG

Montelukast 10 mg po

Montelukast po 10 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (206)

Novartis Investigative Site

Scottsdale, Arizona, 85251, United States

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Encinitas, California, 92024, United States

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Huntington Beach, California, 92647, United States

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Los Angeles, California, 90048, United States

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Orange, California, 92868, United States

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Riverside, California, 92506, United States

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San Diego, California, 92120, United States

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San Diego, California, 92123, United States

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San Jose, California, 95117, United States

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San Mateo, California, 94401, United States

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Stockton, California, 95207, United States

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Centennial, Colorado, 80112, United States

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Denver, Colorado, 80230, United States

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Sarasota, Florida, 34233, United States

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Savannah, Georgia, 31406, United States

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River Forest, Illinois, 60305, United States

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Bangor, Maine, 04401, United States

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Wheaton, Maryland, 20902, United States

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North Dartmouth, Massachusetts, 02747, United States

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Minneapolis, Minnesota, 55402, United States

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St Louis, Missouri, 63141, United States

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Warrensburg, Missouri, 64093, United States

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Omaha, Nebraska, 68130, United States

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Omaha, Nebraska, 68131, United States

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Papillion, Nebraska, 68046, United States

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Skillman, New Jersey, 08558, United States

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Canton, Ohio, 44718, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73103, United States

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Lake Oswego, Oregon, 97035, United States

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Medford, Oregon, 97504-8741, United States

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Erie, Pennsylvania, 16507, United States

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Lincoln, Rhode Island, 02865, United States

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Charleston, South Carolina, 29407, United States

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Dallas, Texas, 75231, United States

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Fort Worth, Texas, 76132, United States

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Waco, Texas, 76712, United States

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South Burlington, Vermont, 05403, United States

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CABA, Buenos Aires, B8000XAV, Argentina

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CABA, Buenos Aires, C1122AAK, Argentina

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CABA, Buenos Aires, C1186ACB, Argentina

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CABA, Buenos Aires, C1425BEN, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Quilmes, Buenos Aires, B1878FNR, Argentina

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San Juan Bautista, Buenos Aires, B2705XAE, Argentina

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Santa Fe, Rosario, S2000DBS, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Buenos Aires, C1115AAB, Argentina

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Buenos Aires, C1125ABE, Argentina

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Mendoza, 5500, Argentina

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Santa Fe, S3000FIL, Argentina

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Feldbach, 8330, Austria

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Grieskirchen, 4710, Austria

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Linz, 4020, Austria

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Thalheim bei Wels, 4600, Austria

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Vienna, 1210, Austria

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Plovdiv, 400, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1463, Bulgaria

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Varna, 9020, Bulgaria

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Ottawa, Ontario, K1Y 4G2, Canada

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Toronto, Ontario, M4V 1R2, Canada

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Québec, Quebec, GIV 4M6, Canada

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Bogota, Cundinamarca, Colombia

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Armenia, Colombia

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Barranquilla, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Ferolles-Attily, France, 77150, France

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Lyon, 69317, France

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Montpellier, 34059, France

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Paris, 75006, France

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Pessac, 33604, France

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Reims, 51092, France

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Strasbourg, 67091, France

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Tarbes, 65013, France

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Athens, GR, 115 27, Greece

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Heraklion - Crete, GR, 711 10, Greece

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Thessaloniki, GR, 570 10, Greece

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Antigua Guatemala, Guatemala

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Guatemala City, 01010, Guatemala

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Guatemala City, 01015, Guatemala

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Balassagyarmat, 2660, Hungary

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Debrecen, 4032, Hungary

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Deszk, 6772, Hungary

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Győr, 9024, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Nyíregyháza, 4400, Hungary

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Százhalombatta, 2440, Hungary

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Törökbálint, 2045, Hungary

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Panjim, Goa, 403 002, India

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Ahmedabad, Gujarat, 380007, India

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Nagpur - Maharashtra, India, 440012, India

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Bangalore, Karnataka, 560 010, India

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Mysore, Karnataka, 570004, India

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Indore, Madhya Pradesh, 452001, India

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Nagpur, Maharashtra, 440 012, India

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Pune, Maharashtra, 411 014, India

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Ludhiana, Punjab, 141001, India

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Jaipur, Rajasthan, 302017, India

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Chennai, Tamil Nadu, 600 006, India

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Coimbatore, Tamil Nadu, 641004, India

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Florence, FI, 50134, Italy

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Pisa, PI, 56124, Italy

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Parma, PR, 43100, Italy

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Nishio, Aichi-ken, 445-8510, Japan

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Fukuoka, Fukuoka, 819-8555, Japan

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Kasuga, Fukuoka, 816-0813, Japan

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Kitakyushu, Fukuoka, 802-0083, Japan

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Kitakyushu, Fukuoka, 820-0052, Japan

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Yanagawa, Fukuoka, 832-0059, Japan

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Mizunami, Gifu, 509-6134, Japan

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Hatsukaichi, Hiroshima, 739-0402, Japan

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Asahikawa, Hokkaido, 070-8644, Japan

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Sapporo, Hokkaido, 060-0061, Japan

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Sapporo, Hokkaido, 062-8618, Japan

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Himeji, Hyōgo, 672-8064, Japan

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Higashiibaraki-gun, Ibaraki, 311-3193, Japan

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Hitachi, Ibaraki, 317-0077, Japan

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Kanazawa, Ishikawa-ken, 920-0853, Japan

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Sakaidechō, Kagawa-ken, 762-0031, Japan

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Kawasaki, Kanagawa, 210-0852, Japan

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Sagamihara, Kanagawa, 228-8522, Japan

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Yokohama, Kanagawa, 231-8682, Japan

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Sendai, Miyagi, 983-8520, Japan

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Kurashiki, Okayama-ken, 712-8064, Japan

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Tsukubo-gun, Okayama-ken, 701-0304, Japan

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Habikino, Osaka, 583-8588, Japan

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Kishiwada, Osaka, 596-8501, Japan

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Sayama, Osaka, 589-0022, Japan

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Koshigaya, Saitama, 343-0851, Japan

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Hamamatsu, Shizuoka, 430-8525, Japan

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Hamamatsu, Shizuoka, 430-8558, Japan

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Hamamatsu, Shizuoka, 434-8511, Japan

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Chiyoda-ku, Tokyo, 1020083, Japan

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Chuo-ku, Tokyo, 103-0027, Japan

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Chuo-ku, Tokyo, 103-0028, Japan

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Edogawa-ku, Tokyo, 134-0083, Japan

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Itabashi-ku, Tokyo, 173-8610, Japan

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Kiyose, Tokyo, 204-8585, Japan

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Minato-ku, Tokyo, 108-8606, Japan

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Setagaya-ku, Tokyo, 158-0097, Japan

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Tachikawa, Tokyo, 190-0013, Japan

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Taitō City, Tokyo, 111-0052, Japan

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Toshima-ku, Tokyo, 171-0014, Japan

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Fukuoka, 811-1394, Japan

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Hiroshima, 732-0052, Japan

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Kochi, 780-8077, Japan

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Kyoto, 612-0026, Japan

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Osaka, 560-0005, Japan

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Mexicali, Estado de Baja California, 21100, Mexico

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Guadalajara, Jalisco, 44130, Mexico

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Guadalajara, Jalisco, 44280, Mexico

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Zapopan, Jalisco, 45040, Mexico

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Mexico City, Mexico City, 03020, Mexico

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Mexico City, Mexico City, 14050, Mexico

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Mexico City, Mexico City, 14080, Mexico

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Monterrey, Nuevo León, 64718, Mexico

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Almelo, 7609 PP, Netherlands

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Harderwijk, 3840 AC, Netherlands

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Jesus Maria, Lima region, 11, Peru

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Lima Cercado, Lima region, 01, Peru

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Miraflores, Lima region, 18, Peru

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San Borja, Lima region, 41, Peru

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San Isidro, Lima region, 27, Peru

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Santiago de Surco, Lima region, 33, Peru

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Katowice, 40-752, Poland

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Krakow, 31-159, Poland

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Bucharest, District 1, 10457, Romania

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Bucharest, District 1, 11475, Romania

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Bucharest, District 3, 030317, Romania

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Craiova, Dolj, 200515, Romania

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Iași, Jud. Iasi, 700115, Romania

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Arad, 310013, Romania

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Arad, 310086, Romania

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Bucharest, 050159, Romania

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Deva, 330162, Romania

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Barnaul, 656024, Russia

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Barnaul, 656045, Russia

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Chelyabinsk, 454021, Russia

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Chelyabinsk, 454047, Russia

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Moscow, 119992, Russia

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Moscow, 125315, Russia

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Ryazan, 390026, Russia

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Saint Petersburg, 193231, Russia

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Saint Petersburg, 194354, Russia

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Yaroslavl, 150003, Russia

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Benoni, South Africa

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Cape Town, 7531, South Africa

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Cape Town, 7925, South Africa

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Durban, 4001, South Africa

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eManzimtoti, 4126, South Africa

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Gatesville, 7764, South Africa

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Port Elizabeth, 6001, South Africa

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Pretoria, 0001, South Africa

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Pretoria, 0181, South Africa

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Fatih / Istanbul, 34098, Turkey (Türkiye)

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Istanbul, 34093, Turkey (Türkiye)

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Istanbul, 34854, Turkey (Türkiye)

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Izmir, 35040, Turkey (Türkiye)

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Mersin, 33079, Turkey (Türkiye)

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Yenisehir/Izmir, 35110, Turkey (Türkiye)

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Newcastle upon Tyne, Newcastle, NE7 7DN, United Kingdom

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Bradford, BD9 6RJ, United Kingdom

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Glasgow - Scotland, G12 OYN, United Kingdom

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Related Publications (1)

• 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.

  PMID: 28838980 DERIVED

Related Links

• Results for CQAW039A2206 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Asthma

Interventions

fevipiprant; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 21, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 19, 2020

Record last verified: 2020-11

Locations

CA (3); GU (3); RO (9); AR (13); BU (5); FR (8); AU (5); US (38); IN (12); IT (3); NL (2); PE (6); TU (6); GR (3); HU (8); RU (10); ME (8); PL (2); JP (45); CO (5); GB (3); ZA (9)