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

Tracking Information

First Received Date ^ICMJE

September 4, 2007

Last Updated Date

October 20, 2009

Start Date ^ICMJE

November 2001

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00525772 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Ciclesonide on Exercise Induced Bronchoconstriction

Official Title ^ICMJE

Effect of Ciclesonide on Exercise Induced Bronchoconstriction

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: ciclesonide
low dose- 50ug and 200ug

Other Name: ciclesonide (Alvesco)
Drug: ciclesonide
high dose- 100ug and 400ug

Other Name: ciclesonide (Alvesco)

Study Arm (s)

Active Comparator: 1
ciclesonide 50 and 200ug

Intervention: Drug: ciclesonide
Active Comparator: 2
ciclesonide 100ug and 400ug

Intervention: Drug: ciclesonide

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 30 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00525772

Other Study ID Numbers ^ICMJE

BY/M1-121, OBCIEX

Has Data Monitoring Committee

Yes

Responsible Party

Paul O'Byrne, McMaster University

Study Sponsor ^ICMJE

Hamilton Health Sciences Corporation

Collaborators ^ICMJE

Kolding Sygehus
Takeda Global Research & Development Center, Inc.

Investigators ^ICMJE

Principal Investigator:

Paul O'Byrne, MD

McMaster University

Information Provided By

McMaster University

Verification Date

October 2009

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

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