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

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

This study has been completed.

First Received: June 4, 2008 Last Updated: October 17, 2008 History of Changes

Sponsor:	Laval University
Collaborator:	AstraZeneca
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00691951

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 III

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

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

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

Sponsors and Collaborators

Laval University

AstraZeneca

More Information

No publications provided

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009