Determinants of Corticosteroid Insensitivity in Smokers With Asthma
1 other identifier
interventional
53
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Jan 2007
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2006
CompletedFirst Posted
Study publicly available on registry
December 14, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedAugust 4, 2011
September 1, 2008
3.6 years
December 12, 2006
August 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma
2 weeks
Study Arms (5)
Group 1
ACTIVE COMPARATORSmokers with asthma
Group 2
ACTIVE COMPARATOREx-smokers with asthma
Group 3
ACTIVE COMPARATORNon-smokers with asthma
Group 4
NO INTERVENTIONNon smokers without asthma
Group 5
NO INTERVENTIONSmokers without asthma or COPD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asthma Research Unit, Glasgow University
Glasgow, Scotland, G12 0YN, United Kingdom
Related Publications (1)
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.
PMID: 21338429DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 12, 2006
First Posted
December 14, 2006
Study Start
January 1, 2007
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
August 4, 2011
Record last verified: 2008-09