A multi-center, Phase IIb, double-blind, randomized, placebo controlled, parallel-group, repeated-dose study in male and female patients with moderate to severe asthma in which patients will be stabilized on AEROVANT then doses of inhaled corticosteroids and LABA will be tapered. The hypothesis is that AEROVANT will improve asthma symptom control and decrease the need for inhaled corticosteroids and LABA, thus improving exacerbation incidence compared to placebo. Incidence of asthma exacerbation is the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
424
Incidence of exacerbation
Time frame: 4 months
In-clinic and daily pulmonary function
Time frame: 4 months
Time to exacerbation after randomization
Time frame: 4 months
Change from baseline in daily asthma symptom scores
Time frame: 4 months
Change from baseline in daily beta-agonist reliever use
Time frame: 4 months
Change from baseline in total IgE
Time frame: 4 months
Change from baseline in fractional concentration of expired nitric oxide (FENO)
Time frame: 4 months
Population pharmacokinetics
Time frame: 4 months
General safety evaluation including lung function, blood pressure, heart rate, respiratory rate, temperature, ECG parameters, safety laboratory tests.
Time frame: 4 months
SNP analysis for IL-4 and IL-13 relevant genes (Exploratory)
Time frame: 4 months
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placebo control (dry powder)
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States
Allergy and Immunology Associates Ltd
Scottsdale, Arizona, United States
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, United States
Allergy Associates Medical Group Inc.
San Diego, California, United States
Institute of Healthcare Assessment Inc.
San Diego, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Allergy and Asthma Clinical Research Inc.
Walnut Creek, California, United States
Colorado Asthma and Allergy Research Centers, P.C.
Centenniel, Colorado, United States
Asthma and Allergy Associates P.C. and Research Center
Colorado Springs, Colorado, United States
National Jewish Health
Denver, Colorado, United States
...and 61 more locations