Effect of Ciclesonide on Exercise Induced Bronchoconstriction

This study has been completed.
Sponsor:
Collaborators:
Kolding Sygehus
Takeda
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00525772
First received: September 4, 2007
Last updated: October 20, 2009
Last verified: October 2009

September 4, 2007
October 20, 2009
November 2001
November 2007   (final data collection date for primary outcome measure)
change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value [ Time Frame: at 1 week of treatment ] [ Designated as safety issue: No ]
change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value [ Time Frame: at 1 week of treatment ]
Complete list of historical versions of study NCT00525772 on ClinicalTrials.gov Archive Site
Changes in sputum cell counts,bronchial responsiveness to mannitol and other clinical parameters of asthma control after treatment compared to respective pre-treatment value. [ Time Frame: after 1, 2, 3, weeks of treatment ] [ Designated as safety issue: No ]
Changes in sputum cell counts,bronchial responsiveness to mannitol and other clinical parameters of asthma control after treatment compared to respective pre-treatment value. [ Time Frame: after 1, 2, 3, weeks of treatment ]
Not Provided
Not Provided
 
Effect of Ciclesonide on Exercise Induced Bronchoconstriction
Effect of Ciclesonide on Exercise Induced Bronchoconstriction

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: ciclesonide
    low dose- 50ug and 200ug
    Other Name: ciclesonide (Alvesco)
  • Drug: ciclesonide
    high dose- 100ug and 400ug
    Other Name: ciclesonide (Alvesco)
  • Active Comparator: 1
    ciclesonide 50 and 200ug
    Intervention: Drug: ciclesonide
  • Active Comparator: 2
    ciclesonide 100ug and 400ug
    Intervention: Drug: ciclesonide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
12 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00525772
BY/M1-121, OBCIEX
Yes
Paul O'Byrne, McMaster University
Hamilton Health Sciences Corporation
  • Kolding Sygehus
  • Takeda
Principal Investigator: Paul O'Byrne, MD McMaster University
McMaster University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP