Determinants of Corticosteroid Insensitivity in Smokers With Asthma

August 3, 2011 updated by: University of Glasgow
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Asthma Research Unit, Glasgow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Smokers with asthma
Drug: oral steroid-dexamethasone
2 week steroid trial
Active Comparator: Group 2
Ex-smokers with asthma
Drug: oral steroid-dexamethasone
2 week steroid trial
Active Comparator: Group 3
Non-smokers with asthma
Drug: oral steroid-dexamethasone
2 week steroid trial
No Intervention: Group 4
Non smokers without asthma
No Intervention: Group 5
Smokers without asthma or COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Collaborators

Chief Scientist Office of the Scottish Government

Investigators

  • Principal Investigator: Neil C Thomson, FRCP, University of Glasgow
  • Principal Investigator: Mark Spears, MRCP, University of Glasgow
  • Principal Investigator: Rekha Chaudhuri, MD, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 12, 2006

First Submitted That Met QC Criteria

December 12, 2006

First Posted (Estimate)

December 14, 2006

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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