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Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00411320
Enrollment
53
Registered
2006-12-14
Start date
2007-01-31
Completion date
2010-09-30
Last updated
2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Corticosteroid Insensitivity, Smoking, Steroid Resistance

Keywords

Asthma, Smoking, Steroid Resistance, Corticosteroid insensitivity

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.

Interventions

2 week steroid trial

Sponsors

Chief Scientist Office of the Scottish Government
CollaboratorOTHER_GOV
University of Glasgow
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma2 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026