Determinants of Corticosteroid Insensitivity in Smokers With Asthma

This study has been completed.
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00411320
First received: December 12, 2006
Last updated: August 3, 2011
Last verified: September 2008

December 12, 2006
August 3, 2011
January 2007
August 2010   (final data collection date for primary outcome measure)
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00411320 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Determinants of Corticosteroid Insensitivity in Smokers With Asthma
Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. The investigators will perform a number of blood & breathing tests to try to discover the cause/s behind this phenomenon with the aim of producing leads for further investigation and possible new treatments for smokers with asthma.

Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. However research into steroid resistance in severe asthma and the smoking related condition chronic obstructive pulmonary disease (COPD) points to a number of possible causes. We will characterise a group of smokers with asthma and perform a number of investigations and compare the results to ex-smokers and never smokers with asthma with the aim of establishing which previously published steroid resistance phenomena are related to the steroid resistance displayed by smokers with asthma. Results produced from this trial will provide hypothesis generating information leading to future pharmaceutical trials.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Asthma
  • Smoking
  • Steroid Resistance
  • Corticosteroid Insensitivity
Drug: oral steroid-dexamethasone
2 week steroid trial
  • Active Comparator: Group 1
    Smokers with asthma
    Intervention: Drug: oral steroid-dexamethasone
  • Active Comparator: Group 2
    Ex-smokers with asthma
    Intervention: Drug: oral steroid-dexamethasone
  • Active Comparator: Group 3
    Non-smokers with asthma
    Intervention: Drug: oral steroid-dexamethasone
  • No Intervention: Group 4
    Non smokers without asthma
  • No Intervention: Group 5
    Smokers without asthma or COPD
Spears M, McSharry C, Donnelly I, Jolly L, Brannigan M, Thomson J, Lafferty J, Chaudhuri R, Shepherd M, Cameron E, Thomson NC. Peripheral blood dendritic cell subtypes are significantly elevated in subjects with asthma. Clin Exp Allergy. 2011 May;41(5):665-72. doi: 10.1111/j.1365-2222.2010.03692.x. Epub 2011 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
September 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Asthma (defined by either reversibility to bronchodilator or methacholine testing)
  • Asthma duration of 6 months or greater
  • Stable asthma
  • Age 18-60
  • Treatment with inhaled corticosteroids
  • Smoking history consistent with group

    • smokers with asthma: > or = 5 pack years and currently smoking more than 5 cigarettes per day
    • ex-smokers: smoking ceased > or = two years prior to recruitment, minimum 5 pack year history
    • non-smokers: no smoking history

Exclusion Criteria:

  • Presence of medical condition likely to be exacerbated by treatment with oral corticosteroids
  • Treatment with > 2000 mcg beclomethasone (or equivalent) per day
  • Subject requires oral corticosteroids to maintain asthma control
  • Subject requires oral theophylline to maintain asthma control
  • Recent treatment with oral corticosteroids
  • Pregnancy or subject planning to become pregnant
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00411320
AR002
Yes
Dr Caroline Watson, R&D Manager, NHS Greater Glasgow and Clyde (North Glasgow University Hospitals Division)
University of Glasgow
Chief Scientist Office of the Scottish Government
Principal Investigator: Mark Spears, MRCP University of Glasgow
Principal Investigator: Neil C Thomson, FRCP University of Glasgow
Principal Investigator: Rekha Chaudhuri, MD University of Glasgow
University of Glasgow
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP