Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laval University
• Collaborator: AstraZeneca
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

Criteria

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