Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Hamilton Health Sciences (HHS)

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: ciclesonide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00525772

OBCIEX

BY/M1-121

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

12 to 30 years old

Volunteers

No Healthy Volunteers

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