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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00163345 |
The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Condition | Intervention | Phase |
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Asthma |
Drug: Ciclesonide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 Mcg Once Daily) Versus Placebo in Patients With Asthma |
Estimated Enrollment: | 20 |
Study Start Date: | September 2003 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Study ID Numbers: | BY9010/M1-131 |
Study First Received: | September 12, 2005 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00163345 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Asthma Ciclesonide Small Airways |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Ciclesonide |
Lung Diseases Hypersensitivity, Immediate Asthma Anti-Allergic Agents Respiratory Hypersensitivity |
Bronchial Diseases Immune System Diseases Ciclesonide Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |