Effect of Ciclesonide on Exercise Induced Bronchoconstriction

October 20, 2009 updated by: Hamilton Health Sciences Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
ciclesonide 50 and 200ug
Drug: ciclesonide
low dose- 50ug and 200ug
Other Names:
  • ciclesonide (Alvesco)
Drug: ciclesonide
high dose- 100ug and 400ug
Other Names:
  • ciclesonide (Alvesco)
ACTIVE_COMPARATOR: 2
ciclesonide 100ug and 400ug
Drug: ciclesonide
low dose- 50ug and 200ug
Other Names:
  • ciclesonide (Alvesco)
Drug: ciclesonide
high dose- 100ug and 400ug
Other Names:
  • ciclesonide (Alvesco)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 1 week of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
after 1, 2, 3, weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Takeda
Kolding Sygehus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (ESTIMATE)

September 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2009

Last Update Submitted That Met QC Criteria

October 20, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY/M1-121
  • OBCIEX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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