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Dose Finding Study for QAW039 in Asthma

NCT ID: NCT01437735

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1043 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma QAW039

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QAW039 po dose 1

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 2

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 3

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 4

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 5

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 6

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 7

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 8

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 9

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 10

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 11

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 12

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

QAW039 po dose 13

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 po

Montelukast po 10 mg

Comparator leukotriene receptor antagonist (LRTA)

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

Montelukast 10 mg po

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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QAW039

QAW039 po

Intervention Type DRUG

Montelukast

Montelukast 10 mg po

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Scottsdale, Arizona, United States

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Encinitas, California, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Jose, California, United States

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San Mateo, California, United States

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Stockton, California, United States

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Centennial, Colorado, United States

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Denver, Colorado, United States

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Sarasota, Florida, United States

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Savannah, Georgia, United States

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River Forest, Illinois, United States

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Bangor, Maine, United States

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Wheaton, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Warrensburg, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Papillion, Nebraska, United States

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Skillman, New Jersey, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Erie, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Waco, Texas, United States

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South Burlington, Vermont, United States

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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San Juan Bautista, Buenos Aires, Argentina

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Santa Fe, Rosario, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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Santa Fe, , Argentina

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Feldbach, , Austria

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Grieskirchen, , Austria

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Linz, , Austria

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Thalheim bei Wels, , Austria

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Vienna, , Austria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, 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, France

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Lyon, , France

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Montpellier, , France

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Paris, , France

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Pessac, , France

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Reims, , France

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Strasbourg, , France

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Tarbes, , France

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Athens, GR, Greece

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Heraklion - Crete, GR, Greece

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Thessaloniki, GR, Greece

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Antigua Guatemala, , Guatemala

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Balassagyarmat, , Hungary

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Debrecen, , Hungary

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Deszk, , Hungary

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Győr, , Hungary

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Mosonmagyaróvár, , Hungary

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Nyíregyháza, , Hungary

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Százhalombatta, , Hungary

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Törökbálint, , Hungary

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Panjim, Goa, India

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Ahmedabad, Gujarat, India

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Nagpur - Maharashtra, India, India

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Bangalore, Karnataka, India

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Mysore, Karnataka, India

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Indore, Madhya Pradesh, India

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Nagpur, Maharashtra, India

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Pune, Maharashtra, India

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Ludhiana, Punjab, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Coimbatore, Tamil Nadu, India

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Florence, FI, Italy

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Pisa, PI, Italy

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Parma, PR, Italy

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Nishio, Aichi-ken, Japan

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Fukuoka, Fukuoka, Japan

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Kasuga, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Yanagawa, Fukuoka, Japan

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Mizunami, Gifu, Japan

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Hatsukaichi, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Himeji, Hyōgo, Japan

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Higashiibaraki-gun, Ibaraki, Japan

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Hitachi, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Sakaidechō, Kagawa-ken, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Sendai, Miyagi, Japan

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Kurashiki, Okayama-ken, Japan

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Tsukubo-gun, Okayama-ken, Japan

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Habikino, Osaka, Japan

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Kishiwada, Osaka, Japan

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Sayama, Osaka, Japan

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Koshigaya, Saitama, Japan

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Hamamatsu, Shizuoka, Japan

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Hamamatsu, Shizuoka, Japan

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Hamamatsu, Shizuoka, Japan

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Chiyoda-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Edogawa-ku, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Kiyose, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Tachikawa, Tokyo, Japan

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Taitō City, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Fukuoka, , Japan

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Hiroshima, , Japan

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Kochi, , Japan

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Kyoto, , Japan

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Osaka, , Japan

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Mexicali, Estado de Baja California, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Almelo, , Netherlands

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Harderwijk, , Netherlands

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Jesus Maria, Lima region, Peru

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Lima Cercado, Lima region, Peru

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Miraflores, Lima region, Peru

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San Borja, Lima region, Peru

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San Isidro, Lima region, Peru

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Santiago de Surco, Lima region, Peru

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Katowice, , Poland

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Krakow, , Poland

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Bucharest, District 1, Romania

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Bucharest, District 1, Romania

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Bucharest, District 3, Romania

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Craiova, Dolj, Romania

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Iași, Jud. Iasi, Romania

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Arad, , Romania

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Arad, , Romania

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Bucharest, , Romania

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Deva, , Romania

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Barnaul, , Russia

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Barnaul, , Russia

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Chelyabinsk, , Russia

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Chelyabinsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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Benoni, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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eManzimtoti, , South Africa

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Gatesville, , South Africa

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Port Elizabeth, , South Africa

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Pretoria, , South Africa

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Pretoria, , South Africa

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Fatih / Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Yenisehir/Izmir, , Turkey (Türkiye)

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Newcastle upon Tyne, Newcastle, United Kingdom

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Bradford, , United Kingdom

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Glasgow - Scotland, , United Kingdom

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Countries

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Germany Philippines Venezuela United States Argentina Austria Bulgaria Canada Colombia France Greece Guatemala Hungary India Italy Japan Mexico Netherlands Peru Poland Romania Russia South Africa Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 28838980 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13023

Results for CQAW039A2206 from the Novartis Clinical Trials website

Other Identifiers

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2011-001062-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAW039A2206

Identifier Type: -

Identifier Source: org_study_id