Clinical trial NCT00403637: Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma
Official title: A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler (SDDPI) vs. Placebo in Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Keywords: Asthma, indacaterol, long acting β2-agonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-27
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 exclusion criteria may apply

Primary outcomes:
measure: Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)
Secondary outcomes:
measure: FEV1 at time points 30 min, 1, 2 and 4 h post-dose
measure: 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
measure: 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
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centres, P.C.
state: Colorado
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: St Louis
country: United States
facility: The Clinical Research Center
state: Missouri
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
Study officials:
affiliation: Novartis
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: