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Determinants of Corticosteroid Insensitivity in Smokers With Asthma

This study has been completed.

Sponsors and Collaborators: University of Glasgow
Chief Scientists Office
Information provided by: University of Glasgow
ClinicalTrials.gov Identifier: NCT00411320
  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

MedlinePlus related topics:   Asthma    Smoking   

ChemIDplus related topics:   Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Corticosteroids   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Further study details as provided by University of Glasgow:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

RNA extraction from peripheral blood


Enrollment:   53
Study Start Date:   January 2007
Study Completion Date:   September 2008
Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
Group 1
Smokers with asthma
Drug: oral steroid-dexamethasone
2 week steroid trial
Group 2
Ex-smokers with asthma
Drug: oral steroid-dexamethasone
2 week steroid trial
Group 3
Non-smokers with asthma
Drug: oral steroid-dexamethasone
2 week steroid trial

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
Sampling Method:   Non-Probability Sample

Study Population

Asthmatics


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

Sponsors and Collaborators
University of Glasgow
Chief Scientists Office

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


unit website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   NHS Greater Glasgow and Clyde (North Glasgow University Hospitals Division) ( Dr Caroline Watson, R&D Manager )
Study ID Numbers:   AR002
First Received:   December 12, 2006
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00411320
Health Authority:   United Kingdom: Research Ethics Committee

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

Study placed in the following topic categories:
Dexamethasone
Smoking
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Dexamethasone acetate
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Bronchial Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Glucocorticoids
Hormones
Pharmacologic Actions
Habits
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 15, 2008




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