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Sponsored by: |
Argenta Discovery Ltd |
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Information provided by: | Argenta Discovery Ltd |
ClinicalTrials.gov Identifier: | NCT00634413 |
The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) when co-administered with budesonide and compared to placebo.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease |
Drug: Theophylline - ADC4022 Drug: Placebo Drug: Budesonide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomised, Double-Blind, Placebo-Controlled Pilot Efficacy Study of ADC4022 on Markers of Pulmonary Inflammation in Subjects With Moderate to Severe COPD |
Enrollment: | 91 |
Study Start Date: | February 2008 |
Study Completion Date: | January 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Theophylline - ADC4022
Inhaled theophylline (ADC4022) administered twice daily for 28 days
Drug: Budesonide
Inhaled budesonide twice daily for 28 days
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2: Placebo Comparator |
Drug: Placebo
Inhaled matching placebo administered twice daily for 28 days
Drug: Budesonide
Inhaled budesonide twice daily for 28 days
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Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may also apply
Poland | |
Silisian Medical University | |
Katowice-Ligota, Poland, 40-752 | |
Jagiellonian University of Medicine | |
Krakow, Poland, 31-066 | |
Medical University in Lodz | |
Lodz, Poland, 90-153 | |
Warsaw University Medical School | |
Warsaw, Poland, 02-097 | |
National Tuberculosis and Lung Diseases Research Institute | |
Warsaw, Poland, 01-138 | |
United Kingdom | |
The London Chest Hospital | |
London, United Kingdom, E2 9JX | |
Medicines Evaluation Unit | |
Manchester, United Kingdom, M23 9QZ | |
United Kingdom, Leicestershire | |
Glenfield Hospital | |
Leicester, Leicestershire, United Kingdom, LE3 9QP |
Principal Investigator: | Neil Barnes, MD PhD | London Chest Hospital |
Responsible Party: | Argenta Discovery Ltd ( Director of Clinical Development ) |
Study ID Numbers: | ADC_4022_CLIN_02P |
Study First Received: | March 6, 2008 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00634413 History of Changes |
Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
COPD |
Anti-Inflammatory Agents Vasodilator Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Cardiovascular Agents Hormones Glucocorticoids Inflammation |
Lung Diseases, Obstructive Phosphodiesterase Inhibitors Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pneumonia Pulmonary Disease, Chronic Obstructive Theophylline |
Anti-Inflammatory Agents Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Budesonide Anti-Asthmatic Agents |
Enzyme Inhibitors Cardiovascular Agents Glucocorticoids Pharmacologic Actions Inflammation Phosphodiesterase Inhibitors Autonomic Agents Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pneumonia Theophylline Pulmonary Disease, Chronic Obstructive |