Clinical trial NCT00411320: Determinants of Corticosteroid Insensitivity in Smokers With Asthma
Official title: Determinants of Corticosteroid Insensitivity in Smokers With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Smoking
Steroid Resistance
Corticosteroid Insensitivity
Keywords: Asthma
Smoking
Steroid Resistance
Corticosteroid insensitivity
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
First posted: 2006-12-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Asthma Research Unit, Glasgow University
state: Scotland
Study officials:
affiliation: University of Glasgow
name: Mark Spears, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Neil C Thomson, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Rekha Chaudhuri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.