Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Study Overview
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Brief Summary
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The purpose of this study is to study the effects of once daily inhaled ciclesonide at varying doses on exercise provoked asthma symptoms, fall in lung function after exercise and sputum characteristics.

Detailed Description
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To study the effects of 4 doses of ciclesonide on exercise-induced bronchoconstriction, bronchial responsiveness to mannitol, sputum parameters and other parameters of asthma control in asthmatic patients. The primary aim was to evaluate exercise-induced bronchoconstriction as a method of determining the dose and time responses of inhaled corticosteroid therapy. The secondary aims were to evaluate the dose and time responses of sputum parameters and responsiveness to mannitol to inhaled corticosteroid therapy. Furthermore to explore the relationship(s) between exercise induced bronchoconstriction, sputum parameters and mannitol responsiveness.

Official Title
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Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Conditions
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Asthma

Intervention / Treatment
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* Drug: ciclesonide
* Drug: ciclesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable asthma not on maintenance asthma medications exercise induced bronchoconstriction on dry air exercise challenge. Exclusion Criteria: other significant co-morbidity or treatments that might interfere with the conduct or results of the study fail to return to baseline after a maximum washout period of 8 weeks unable to perform the procedures of the study

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ciclesonide 50 and 200ug | Drug: ciclesonide<br>* low dose- 50ug and 200ug<br>* Other names: ciclesonide (Alvesco);|
| Active Comparator: 2<br>ciclesonide 100ug and 400ug | Drug: ciclesonide<br>* high dose- 100ug and 400ug<br>* Other names: ciclesonide (Alvesco);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value |  | at 1 week of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sputum cell counts,bronchial responsiveness to mannitol and other clinical parameters of asthma control after treatment compared to respective pre-treatment value. |  | after 1, 2, 3, weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, exercise induced bronchoconstriction, sputum eosinophils