Dose Finding Study for QAW039 in Asthma (NCT01437735) | Clinical Trial Compass
CompletedPhase 2
Dose Finding Study for QAW039 in Asthma
United States1,043 participantsStarted 2011-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12