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Effect of Ciclesonide on Exercise Induced Bronchoconstriction

This study has been completed.
Sponsor:
Collaborators:
Kolding Sygehus
Takeda Global Research & Development Center, Inc.
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00525772
First received: September 4, 2007
Last updated: October 20, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: ciclesonide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Resource links provided by NLM:

Drug Information available for: Ciclesonide
U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: November 2001
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ciclesonide 50 and 200ug
 Drug: ciclesonide
low dose- 50ug and 200ug
Other Name: ciclesonide (Alvesco)
Active Comparator: 2
ciclesonide 100ug and 400ug
 Drug: ciclesonide
high dose- 100ug and 400ug
Other Name: ciclesonide (Alvesco)

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

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525772

Locations
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Kolding Sygehus
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Paul O'Byrne, MD McMaster University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul O'Byrne, McMaster University
ClinicalTrials.gov Identifier: NCT00525772     History of Changes
Other Study ID Numbers: BY/M1-121, OBCIEX
Study First Received: September 4, 2007
Last Updated: October 20, 2009
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
asthma
exercise induced bronchoconstriction
sputum eosinophils

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013