Skip to content

Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00691951
Acronym
D5890L00013
Enrollment
Unknown
Registered
2008-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2008-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGbudesonide and budesonide/formoterol

Sponsors

Laval University
Lead SponsorOTHER
AstraZeneca
CollaboratorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)

Secondary

MeasureTime frame
Other control scores (ACSS score) and rescue B2 agonist need
Comparative changes in FEV1
Quality of life questionnaire
Morning and evening PEF
Total and differential cell counts in induced sputum and ECP and MPO

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026