search
Back to results

Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Primary Purpose

Asthma, Smoking, Steroid Resistance

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
oral steroid-dexamethasone
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring Asthma, Smoking, Steroid Resistance, Corticosteroid insensitivity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asthma Research Unit, Glasgow University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

Smokers with asthma

Ex-smokers with asthma

Non-smokers with asthma

Non smokers without asthma

Smokers without asthma or COPD

Outcomes

Primary Outcome Measures

bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma

Secondary Outcome Measures

Full Information

First Posted
December 12, 2006
Last Updated
August 3, 2011
Sponsor
University of Glasgow
Collaborators
Chief Scientist Office of the Scottish Government
search

1. Study Identification

Unique Protocol Identification Number
NCT00411320
Brief Title
Determinants of Corticosteroid Insensitivity in Smokers With Asthma
Official Title
Determinants of Corticosteroid Insensitivity in Smokers With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Glasgow
Collaborators
Chief Scientist Office of the Scottish Government

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Smoking, Steroid Resistance, Corticosteroid Insensitivity
Keywords
Asthma, Smoking, Steroid Resistance, Corticosteroid insensitivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Smokers with asthma
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Ex-smokers with asthma
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Non-smokers with asthma
Arm Title
Group 4
Arm Type
No Intervention
Arm Description
Non smokers without asthma
Arm Title
Group 5
Arm Type
No Intervention
Arm Description
Smokers without asthma or COPD
Intervention Type
Drug
Intervention Name(s)
oral steroid-dexamethasone
Intervention Description
2 week steroid trial
Primary Outcome Measure Information:
Title
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Spears, MRCP
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil C Thomson, FRCP
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rekha Chaudhuri, MD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asthma Research Unit, Glasgow University
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21338429
Citation
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.
Results Reference
derived
Links:
URL
http://www.gla.ac.uk/departments/immunology/respiratorymedicine/
Description
unit website

Learn more about this trial

Determinants of Corticosteroid Insensitivity in Smokers With Asthma

We'll reach out to this number within 24 hrs