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|---|---|---|---|
| OBCIEX |
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| Name | Class |
|---|---|
| Kolding Sygehus | OTHER |
| Takeda | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | ciclesonide 50 and 200ug |
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| 2 | Active Comparator | ciclesonide 100ug and 400ug |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ciclesonide | Drug | low dose- 50ug and 200ug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value | at 1 week of treatment |
| Measure | Description | 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. | after 1, 2, 3, weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul O'Byrne, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University Medical Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16675326 | Background | Subbarao P, Duong M, Adelroth E, Otis J, Obminski G, Inman M, Pedersen S, O'byrne PM. Effect of ciclesonide dose and duration of therapy on exercise-induced bronchoconstriction in patients with asthma. J Allergy Clin Immunol. 2006 May;117(5):1008-13. doi: 10.1016/j.jaci.2005.11.048. | |
| 18071011 | Derived | Duong M, Subbarao P, Adelroth E, Obminski G, Strinich T, Inman M, Pedersen S, O'Byrne PM. Sputum eosinophils and the response of exercise-induced bronchoconstriction to corticosteroid in asthma. Chest. 2008 Feb;133(2):404-11. doi: 10.1378/chest.07-2048. Epub 2007 Dec 10. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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| ciclesonide | Drug | high dose- 100ug and 400ug |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |