Asthma Clinical Trial
— D5890L00013Official title:
Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study
| NCT number | NCT00691951 |
| Other study ID # | Symbicort smokers AZ |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | June 4, 2008 |
| Last updated | October 17, 2008 |
| Verified date | June 2008 |
| Source | Laval University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hôpital du Sacré-Coeur de Montreal | Montréal | Quebec |
| Canada | Laval Hospital | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Laval University | AstraZeneca |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ) | |||
| Secondary | Other control scores (ACSS score) and rescue B2 agonist need | |||
| Secondary | Comparative changes in FEV1 | |||
| Secondary | Quality of life questionnaire | |||
| Secondary | Morning and evening PEF | |||
| Secondary | Total and differential cell counts in induced sputum and ECP and MPO |
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