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
NCT00403637 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2016-11-18
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
Conditions
Interventions
- DRUG
-
indacaterol maleate
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis · Novartis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 12 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2007-02-28
- Completion
- 2007-02-28
Countries
- United States
Study Locations
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