D5890L00013: Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects

• Sponsor: Laval University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00691951
• Collaborator: AstraZeneca (Industry)
• Locations: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: budesonide and budesonide/formoterol	Phase 3

Study Design

• Study Type: Interventional
• Official Title: Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study

Outcome Measures

Primary Outcome Measures

1. Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ) []

Secondary Outcome Measures

1. Other control scores (ACSS score) and rescue B2 agonist need []

2. Comparative changes in FEV1 []

3. Quality of life questionnaire []

4. Morning and evening PEF []

5. Total and differential cell counts in induced sputum and ECP and MPO []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital du Sacré-Coeur de Montreal	Montréal	Quebec	Canada	H4J 1C5
2	Laval Hospital	Quebec		Canada	G1V 4G5

Sponsors and Collaborators

• Laval University
• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00691951
• Other Study ID Numbers: Symbicort smokers AZ
• First Posted: Jun 6, 2008
• Last Update Posted: Oct 21, 2008
• Last Verified: Jun 1, 2008

• Additional relevant MeSH terms: Asthma; Budesonide; Formoterol Fumarate

Study Results

No Results Posted as of Oct 21, 2008