Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00525772

Enrollment

Registered

2007-09-06

Start date

2001-11-30

Completion date

2007-11-30

Last updated

2009-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, exercise induced bronchoconstriction, sputum eosinophils

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.

Interventions

DRUGciclesonide

low dose- 50ug and 200ug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 30 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026