Asthma
Conditions
Keywords
Asthma, indacaterol, long acting β2-agonist
Brief summary
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females 12 - 75 years of age with a diagnosis of persistent asthma * Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent * FEV1 at Visit 1 at least 50% of the predicted normal value * FEV1 reversibility at least 15%
Exclusion criteria
* Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years * Chronic Obstructive Pulmonary Disease (COPD) * Seasonal allergy where asthma is likely to deteriorate during the period of the study * Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months * A respiratory tract infection within the previous 6 weeks Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function measured 24 hours after having taken medication, by a special test called forced expiratory volume in 1 second (FEV1) | — |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 at time points 30 min, 1, 2 and 4 h post-dose | — |
| Percent change in FEV1 at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose | — |
| Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose | — |
Countries
United States
Outcome results
None listed