Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
NCT00314509 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2016-12-05
Summary
The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.
Conditions
Interventions
- DRUG
-
Ciclesonide/Formoterol Combination
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AstraZeneca AstraZeneca · AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-07-31
- Primary Completion
- 2006-01-31
- Completion
- 2006-01-31
Countries
- France
- Germany
- Hungary
- South Africa
Study Locations
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