Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects

NCT ID: NCT00691951

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to non-smoking asthmatic patients. However, the comparative response to other currently prescribed medications such as combination therapy of long-acting beta agonists and ICS remain to be further evaluated.

No significant differences were found between our group of subjects in regard to changes in asthma control pulmonary function and airway inflammation following budesonide or the association of budesonide with formoterol for a period of 2 months. This should be further explored in larger groups of subjects.

Detailed Description

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Conditions

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Asthma

Interventions

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budesonide and budesonide/formoterol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Asthmatic non-smokers or ex-smokers (less than 10 pack/years)
* Asthmatic smokers (more than 5 cigarettes a day and more than 5 pack/years
* FEV1 greater than 70%
* No more than 3 doses of rescue medication (bronchodilator) per day

Exclusion Criteria

* Mentally or legally incapacitated thus preventing informed consent from being obtained
* Other pulmonary disorder
* History of upper respiratory tract infection in the last month
* Pregnant or lactating women
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Laval University

Locations

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Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, Canada

Site Status

Laval Hospital

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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Symbicort smokers AZ

Identifier Type: -

Identifier Source: org_study_id