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Rosiglitazone Versus Theophylline in Asthmatic Smokers

NCT00119496 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2010-01-27

No results posted yet for this study

Summary

Asthmatic smokers display a blunted response to both inhaled and oral corticosteroid treatments and are at increased risk for exacerbations and near fatal asthma. The prevalence of smoking in asthmatics runs between 20-30%. Therefore, new, more efficacious treatments are required.

Recent work has demonstrated a mechanism which may explain steroid resistance. A commonly used drug called theophylline can reverse this steroid resistance in laboratory studies. Another commonly used drug, rosiglitazone can reverse smoking induced lung inflammation in laboratory studies.

The investigators aim to study the effects of these drugs on smoking asthmatics' lung function and other parameters including quality of life and asthma control.

Conditions

Interventions

DRUG

rosiglitazone

oral tablet, 4mg bd for 4 weeks

DRUG

theophylline

Oral theophylline, 200mg bd

DRUG

beclomethasone

inhaled beclomethasone, 200mcg bd

DRUG

inhaled beclomethasone and oral theophylline

inhaled beclomethasone (400mcg/day), oral theophylline (400mg/day)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Chest, Heart and Stroke Association Scotland

    collaborator OTHER

  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV

  • University of Glasgow

    lead OTHER

Principal Investigators

  • Neil C Thomson, MD · University of Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Completion
2007-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00119496 on ClinicalTrials.gov