Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Asthma Clinical Trial

Official title:

Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411320
• Other study ID #: AR002
• Status: Completed
• Phase: N/A
• First received: December 12, 2006
• Last updated: August 3, 2011
• Start date: January 2007
• Est. completion date: September 2010

Study information

• Verified date: September 2008
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma
• Corticosteroid Insensitivity
• Smoking
• Steroid Resistance

Intervention

Drug:
• oral steroid-dexamethasone
2 week steroid trial

Locations

Country	Name	City	State
United Kingdom	Asthma Research Unit, Glasgow University	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	Chief Scientist Office of the Scottish Government

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma		2 weeks	No

External Links

•   unit website