Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Nycomed |
---|---|
Information provided by: | Nycomed |
ClinicalTrials.gov Identifier: | NCT00826969 |
The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Ciclesonide Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-Blind, Randomized, Parallel Group Study. |
Estimated Enrollment: | 100 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Ciclesonide 320µg
|
Drug: Ciclesonide
320µg Ciclesonide versus Placebo
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nycomed Clinical Trial Management | +497531840 | clinicaltrials@nycomed.com |
Switzerland | |
Nycomed | Recruiting |
Basel, Switzerland, 4031 | |
Contact: Nycomed Clinical Trial Management clinicaltrials@nycomed.com |
Study Chair: | Nycomed Clinical Trial Management | Headquarter |
Responsible Party: | Nycomed ( Nycomed ) |
Study ID Numbers: | BY9010/CH-101 |
Study First Received: | January 21, 2009 |
Last Updated: | July 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00826969 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Asthma Ciclesonide |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Mannitol 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 |