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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00691951
First received: June 4, 2008
Last updated: October 17, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: budesonide and budesonide/formoterol
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Smoking
U.S. FDA Resources

Further study details as provided by Laval University:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691951

Locations
Canada, Quebec
Hôpital du Sacré-Coeur de Montreal
Montréal, Quebec, Canada, H4J 1C5
Canada
Laval Hospital
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
AstraZeneca
  More Information

No publications provided

Responsible Party: Louis-Philippe Boulet, Laval University
ClinicalTrials.gov Identifier: NCT00691951     History of Changes
Other Study ID Numbers: Symbicort smokers AZ
Study First Received: June 4, 2008
Last Updated: October 17, 2008
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013