Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: ciclesonide

• Registration Number: NCT00525772
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-05
• Study First Posted: 2007-09-06
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-20
• Last Update Posted: 2009-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	ciclesonide	ciclesonide 50 and 200ug
2	ciclesonide	ciclesonide 100ug and 400ug

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada