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Determinants of Corticosteroid Insensitivity in Smokers With Asthma

This study has been completed.
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00411320
First received: December 12, 2006
Last updated: August 3, 2011
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention
Asthma
Smoking
Steroid Resistance
Corticosteroid Insensitivity
 Drug: oral steroid-dexamethasone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: January 2007
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411320

Locations
United Kingdom
Asthma Research Unit, Glasgow University
Glasgow, Scotland, United Kingdom, G12 0YN
Sponsors and Collaborators
University of Glasgow
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Mark Spears, MRCP University of Glasgow
Principal Investigator: Neil C Thomson, FRCP University of Glasgow
Principal Investigator: Rekha Chaudhuri, MD University of Glasgow
  More Information

Additional Information:
unit website  This link exits the ClinicalTrials.gov site

No publications provided by University of Glasgow

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Caroline Watson, R&D Manager, NHS Greater Glasgow and Clyde (North Glasgow University Hospitals Division)
ClinicalTrials.gov Identifier: NCT00411320     History of Changes
Other Study ID Numbers: AR002
Study First Received: December 12, 2006
Last Updated: August 3, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Glasgow:
Asthma
Smoking
Steroid Resistance
Corticosteroid insensitivity

Additional relevant MeSH terms:
Asthma
Smoking
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Habits
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013