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| Sponsor: | Pulmagen Therapeutics |
|---|---|
| Information provided by: | Pulmagen Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00634413 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
Drug: Theophylline - ADC4022
Inhaled theophylline (ADC4022) administered twice daily for 28 days
Other Name: ADC4022
Drug: Budesonide
Inhaled budesonide twice daily for 28 days
Other Name: Pulmicort
|
| Placebo Comparator: 2 |
Drug: Placebo
Inhaled matching placebo administered twice daily for 28 days
Drug: Budesonide
Inhaled budesonide twice daily for 28 days
Other Name: Pulmicort
|
Eligibility| 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
Contacts and Locations| 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 | |
| Glenfield Hospital | |
| Leicester, Leicestershire, United Kingdom, LE3 9QP | |
| The London Chest Hospital | |
| London, United Kingdom, E2 9JX | |
| Medicines Evaluation Unit | |
| Manchester, United Kingdom, M23 9QZ | |
| Principal Investigator: | Neil Barnes, MD PhD | London Chest Hospital |
More Information
| Responsible Party: | Director of Clinical Development, Argenta Discovery Ltd |
| ClinicalTrials.gov Identifier: | NCT00634413 History of Changes |
| Other Study ID Numbers: | ADC_4022_CLIN_02P |
| Study First Received: | March 6, 2008 |
| Last Updated: | February 27, 2009 |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
COPD |
|
Inflammation Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Pneumonia Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Theophylline Budesonide Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Vasodilator Agents Cardiovascular Agents Glucocorticoids Hormones |