Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Not Applicable

Completed

• Conditions: Asthma; Smoking; Steroid Resistance; Corticosteroid Insensitivity
• Interventions: Drug: oral steroid-dexamethasone

• Registration Number: NCT00411320
• Lead Sponsor: University of Glasgow

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.

Study Timeline

• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-14
• Study Start: 2007-01
• Status Verified: 2008-09
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	oral steroid-dexamethasone	Smokers with asthma
Group 2	oral steroid-dexamethasone	Ex-smokers with asthma
Group 3	oral steroid-dexamethasone	Non-smokers with asthma

Primary Outcome Measures

Name	Time	Method
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma	2 weeks

Trial Locations

Locations (1)

Asthma Research Unit, Glasgow University; 🇬🇧 Glasgow, Scotland, United Kingdom