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Effect of Ciclesonide on Exercise Induced Bronchoconstriction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00525772
First Posted: September 6, 2007
Last Update Posted: October 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Kolding Sygehus
Takeda
Information provided by:
McMaster University
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Resource links provided by NLM:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525772


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

Publications:
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
First Submitted: September 4, 2007
First Posted: September 6, 2007
Last Update Posted: October 21, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents