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Completed

NCT Number: NCT00691951

Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital du Sacré-Coeur de Montreal, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide and budesonide/formoterol

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: D5890L00013

Important dates

First posted
Jun 6, 2008
Registry last updated
Oct 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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