Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	June 4, 2008
Last Updated Date	October 17, 2008
Start Date ^†
Current Primary Outcome Measures ^† (submitted: October 20, 2008)	Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00691951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: October 20, 2008)	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
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
Official Title ^†	Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study
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.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†
Condition ^†	Asthma
Intervention ^†	Drug: budesonide and budesonide/formoterol
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†
Completion Date
Primary Completion Date
Eligibility 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
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	Canada
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00691951
Responsible Party	Louis-Philippe Boulet, Laval University
Secondary IDs ^††
Study Sponsor ^†	Laval University
Collaborators ^††	AstraZeneca
Investigators ^†
Information Provided By	Laval University
Verification Date	June 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.