Clinical trial NCT00525772: Effect of Ciclesonide on Exercise Induced Bronchoconstriction
Official title: Effect of Ciclesonide on Exercise Induced Bronchoconstriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
exercise induced bronchoconstriction
sputum eosinophils
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Kolding Sygehus
name: Takeda
First posted: 2007-09-06
Enrollment: 26
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value
timeFrame: at 1 week of treatment
Secondary outcomes:
measure: Changes in sputum cell counts,bronchial responsiveness to mannitol and other clinical parameters of asthma control after treatment compared to respective pre-treatment value.
timeFrame: after 1, 2, 3, weeks of treatment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Paul O'Byrne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Subbarao P, Duong M, Adelroth E, Otis J, Obminski G, Inman M, Pedersen S, O'byrne PM. Effect of ciclesonide dose and duration of therapy on exercise-induced bronchoconstriction in patients with asthma. J Allergy Clin Immunol. 2006 May;117(5):1008-13. doi: 10.1016/j.jaci.2005.11.048.
citation: Duong M, Subbarao P, Adelroth E, Obminski G, Strinich T, Inman M, Pedersen S, O'Byrne PM. Sputum eosinophils and the response of exercise-induced bronchoconstriction to corticosteroid in asthma. Chest. 2008 Feb;133(2):404-11. doi: 10.1378/chest.07-2048. Epub 2007 Dec 10.