Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Asthma Clinical Trial

Official title:

Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525772
• Other study ID #: BY/M1-121
• Secondary ID: OBCIEX
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2007
• Last updated: October 20, 2009
• Start date: November 2001
• Est. completion date: November 2007

Study information

• Verified date: October 2009
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ciclesonide
low dose- 50ug and 200ug
• ciclesonide
high dose- 100ug and 400ug

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Kolding Sygehus, Takeda

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No