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

This study has been completed.
Information provided by:
Laval University Identifier:
First received: June 4, 2008
Last updated: October 17, 2008
Last verified: June 2008

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
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:

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


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00691951

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

No publications provided

Responsible Party: Louis-Philippe Boulet, Laval University 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:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on November 24, 2014