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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
NCT00626171 |
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Date of registration:
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20/02/2008 |
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Primary sponsor: |
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Public title:
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Role of Cigarette Smoking in Regulating Allergen-induced Early and Late Responses in Mild Asthmatics
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Scientific title:
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A Study Evaluating the Role of Cigarette Smoking in Regulating Allergen-induced Early and Late Responses in Mild Asthmatics. |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00626171 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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Canada
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Contacts
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Name:
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Gail Gauvreau, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Name:
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Paul O'Byrne, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with mild atopic asthma, presently well controlled on ß2-agonist only.
- Baseline FEV1 more than or equal to 70% of predicted normal.
Exclusion Criteria:
- Past or present cardiovascular, renal, liver or endocrine disease.
- Airway infection during the last 4 weeks.
- Exacerbation during the last 4 weeks.
- Inhaled or oral steroids during the last 4 weeks.
- Anti-asthma medication other than inhaled and/or oral ß2-agonists during the last 4
weeks.
- Pregnant or lactating women or women actively seeking pregnancy or lack of adequate
contraception.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Procedure: Allergen Challenge
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Primary Outcome(s)
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To measure the number of inflammatory cells in induced sputum following allergen challenge in smoking and non-smoking asthmatic subjects.
[Time Frame: 7h and 24 h post]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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