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Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects (D5890L00013)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
budesonide and budesonide/formoterol
Sponsored by
Laval University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Asthma

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital du Sacré-Coeur de Montreal
  • Laval Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2008
Last Updated
October 17, 2008
Sponsor
Laval University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00691951
Brief Title
Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
Acronym
D5890L00013
Official Title
Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Laval University
Collaborators
AstraZeneca

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
budesonide and budesonide/formoterol
Primary Outcome Measure Information:
Title
Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)
Secondary Outcome Measure Information:
Title
Other control scores (ACSS score) and rescue B2 agonist need
Title
Comparative changes in FEV1
Title
Quality of life questionnaire
Title
Morning and evening PEF
Title
Total and differential cell counts in induced sputum and ECP and MPO

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hôpital du Sacré-Coeur de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Laval Hospital
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects

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