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Sponsored by: |
ALTANA Pharma |
---|---|
Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00384189 |
The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Ciclesonide Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma |
Estimated Enrollment: | 1050 |
Study Start Date: | October 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Ciclesonide 40µg
|
Drug: Ciclesonide
inhaled Ciclesonide
|
2: Active Comparator
Ciclesonide 80µg
|
Drug: Ciclesonide
inhaled Ciclesonide
|
3: Active Comparator
160µg
|
Drug: Ciclesonide
inhaled Ciclesonide
|
4: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Principal Investigator: | Søren Pedersen, Prof. | Odense University Hospital, Kolding, Denmark |
Responsible Party: | Nycomed ( Nycomed GmbH ) |
Study ID Numbers: | BY9010/M1-209 |
Study First Received: | October 4, 2006 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00384189 History of Changes |
Health Authority: | South Africa: Medicines Control Council |
Asthma Ciclesonide children |
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 |