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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00163293 |
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
Condition | Intervention | Phase |
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Asthma |
Drug: Ciclesonide Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | POPCICLE: Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations |
Estimated Enrollment: | 300 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Ciclesonide 100µg
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Drug: Ciclesonide
Efficacy of Ciclesonide inhaled
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2: Active Comparator
Ciclesonide 200µg
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Drug: Ciclesonide
Efficacy of Ciclesonide inhaled
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3: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 4 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
chronic bronchitis or emphysema)
Canada | |
Altana Pharma/Nycomed | |
Fleurimont, Canada, J1H 5M4 | |
Altana Pharma/Nycomed | |
London,ON, Canada, N6A1V2 | |
Altana Pharma/Nycomed | |
London, Canada, N6C 4Y7 | |
Altana Pharma/Nycomed | |
Winnipeg, Canada, R3A1R9 | |
Altana Pharma/Nycomed | |
Calgary, Canada, T2T5C7 |
Study Chair: | Allan Becker, Dr | Children's Hospital, Winnipeg, Manitoba, Canada |
Study Chair: | Søren Pedersen, Prof. | University of Odense, Kolding, Denmark |
Responsible Party: | Nycomed ( Nycomed GmbH ) |
Study ID Numbers: | BY9010/CA-101 |
Study First Received: | September 12, 2005 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00163293 History of Changes |
Health Authority: | Canada: Health Canada |
Asthma Ciclesonide Exacerbation |
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 |