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Sponsors and Collaborators: |
University of Glasgow GlaxoSmithKline Chest, Heart and Stroke Association Scotland Chief Scientists Office |
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Information provided by: | University of Glasgow |
ClinicalTrials.gov Identifier: | NCT00119496 |
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.
Condition | Intervention | Phase |
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Asthma |
Drug: rosiglitazone Drug: theophylline Drug: beclomethasone Drug: inhaled beclomethasone and oral theophylline |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Clinical Study to Investigate the Effect of Rosiglitazone, Theophylline and Inhaled Corticosteroid, Inflammation and Pulmonary Function in Asthmatic Smokers |
Enrollment: | 79 |
Study Start Date: | July 2005 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
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Group 1: Active Comparator
Inhaled beclomethasone (400mcg/day)
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Drug: beclomethasone
inhaled beclomethasone, 200mcg bd
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Arm 2: Active Comparator
Rosiglitazone
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Drug: rosiglitazone
oral tablet, 4mg bd for 4 weeks
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Arm3: Active Comparator
Oral theophylline
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Drug: theophylline
Oral theophylline, 200mg bd
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Arm 4: Active Comparator
Oral theophylline and inhaled beclomethasone
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Drug: inhaled beclomethasone and oral theophylline
inhaled beclomethasone (400mcg/day), oral theophylline (400mg/day)
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Smoking asthmatics have chronic pulmonary inflammation that is relatively steroid resistant. PPAR agonists (of which rosiglitazone is one example) have been shown to reduce several markers of inflammation in humans and in smoking animal models.
This clinical study will use smoking asthmatics as a human model of smoke-induced steroid-insensitive airway inflammation to evaluate both efficacy of rosiglitazone as an anti-inflammatory drug as well as the effect of low doses of theophylline on the response to low-dose inhaled corticosteroid (LD ICS).
Mild or moderate (as per GINA guidelines) persistent-asthmatic smokers will be randomised into this study after a 4-week washout period during which they will be withdrawn from inhaled corticosteroids (ICS). Subjects will then receive one of four treatments for 28 days: rosiglitazone, LD ICS, theophylline, or LD ICS plus theophylline. The effects of rosiglitazone and LD ICS on pulmonary function will be compared as a primary objective. In addition, effects of theophylline plus LD ICS will be compared against theophylline and LD ICS separately. Both pulmonary anti-inflammatory and systemic anti-inflammatory activity will also be investigated.
Subjects will have baseline assessments of pulmonary function, biomarkers of systemic inflammation, sputum, exhaled breath biomarkers, asthma control questionnaires and safety parameters. Following 28 days of treatment, these parameters will all be reassessed in all subjects.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects who require treatment with any of the following asthma medications from Screening (Visit 1) until study completion:
United Kingdom, Scotland | |
Asthma Research Group, Gartnavel General Hospital | |
Glasgow, Scotland, United Kingdom, G12 0YN |
Principal Investigator: | Neil C Thomson, MD | University of Glasgow |
Study ID Numbers: | RES104033, 2004-004247-22 EUDRACT |
Study First Received: | July 1, 2005 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00119496 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Corticosteroid Rosiglitazone Theophylline Beclomethasone |
Inflammation Asthma Smoking Pulmonary |
Anti-Inflammatory Agents Vasodilator Agents Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Hormones Smoking Hypersensitivity Lung Diseases, Obstructive Hypoglycemic Agents Respiratory Tract Diseases Rosiglitazone |
Asthma Anti-Asthmatic Agents Cardiovascular Agents Glucocorticoids Inflammation Phosphodiesterase Inhibitors Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Theophylline Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Hormones Hypersensitivity Lung Diseases, Obstructive Hypoglycemic Agents Respiratory Tract Diseases Therapeutic Uses Rosiglitazone |
Immune System Diseases Asthma Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents Glucocorticoids Pharmacologic Actions Phosphodiesterase Inhibitors Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Theophylline Respiratory Hypersensitivity |