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Completed

NCT Number: NCT00525772

Effect of Ciclesonide on Exercise Induced Bronchoconstriction

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciclesonide

Drug

low dose- 50ug and 200ug

Other names: ciclesonide (Alvesco)

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Kolding Sygehus
  • Takeda

Registry information

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 6, 2007
Registry last updated
Oct 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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