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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00691951
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : October 21, 2008
Information provided by:
Laval University

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide and budesonide/formoterol Phase 3

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Smoking

Primary Outcome Measures :
  1. Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)

Secondary Outcome Measures :
  1. Other control scores (ACSS score) and rescue B2 agonist need
  2. Comparative changes in FEV1
  3. Quality of life questionnaire
  4. Morning and evening PEF
  5. Total and differential cell counts in induced sputum and ECP and MPO

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00691951

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

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Responsible Party: Louis-Philippe Boulet, Laval University Identifier: NCT00691951    
Other Study ID Numbers: Symbicort smokers AZ
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action