Determinants of Corticosteroid Insensitivity in Smokers With Asthma

NCT ID: NCT00411320

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Asthma Smoking Steroid Resistance Corticosteroid Insensitivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

Smokers with asthma

Group Type ACTIVE_COMPARATOR

oral steroid-dexamethasone

Intervention Type DRUG

2 week steroid trial

Group 2

Ex-smokers with asthma

Group Type ACTIVE_COMPARATOR

oral steroid-dexamethasone

Intervention Type DRUG

2 week steroid trial

Group 3

Non-smokers with asthma

Group Type ACTIVE_COMPARATOR

oral steroid-dexamethasone

Intervention Type DRUG

2 week steroid trial

Group 4

Non smokers without asthma

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 5

Smokers without asthma or COPD

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oral steroid-dexamethasone

2 week steroid trial

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role lead

Responsible Party

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NHS Greater Glasgow and Clyde (North Glasgow University Hospitals Division)

Principal Investigators

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Mark Spears, MRCP

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Neil C Thomson, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Rekha Chaudhuri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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Asthma Research Unit, Glasgow University

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 21338429 (View on PubMed)

Related Links

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Other Identifiers

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AR002

Identifier Type: -

Identifier Source: org_study_id

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