Status:
COMPLETED
Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD
Lead Sponsor:
Pulmagen Therapeutics
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
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 biops...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of COPD that has been symptomatic for at least 2 years
- The subject has moderate to severe COPD, as defined by the American Thoracic Society and the European Respiratory Society
- The subject can produce an adequate sputum specimen after induction
- The subject has a history of ≥ 10-pack years of cigarette smoking
- The subject has either a ≤15% increase or ≤200 ml increase in FEV1 from pre-dose following a fixed dose of bronchodilator therapy
- The subject is able to provide written, informed consent to participate
Exclusion
- The subject has experienced a respiratory tract infection and/or an exacerbation of COPD within 30 days
- The subject uses systemic corticosteroids (oral or parenteral)
- The subject has received long term oxygen therapy within 30 days
- The subject has a previous history or diagnosis of asthma
- The subject has a chest x-ray within the past 12 months which is diagnostic of an active or clinically significant disease other than COPD
- The subject has a history or presence of active tuberculosis, cystic fibrosis, bronchiectasis, lung cancer or sarcoidosis or any other clinically important lung diseases
- The subject has had radiation or chemotherapy within the previous 12 months
- The subject has a history of anaphylaxis associated with medicinal products
- The subject is pregnant, intends to become pregnant, or is breast feeding
- The subject's alcohol intake is excessive.
- The subject participated in another study (for a marketed drug) within 3 months before the start of this study or (for an investigational drug) within 4 months before the start of this study.
- Other inclusion/exclusion criteria may also apply
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00634413
Start Date
February 1 2008
End Date
January 1 2009
Last Update
March 2 2009
Active Locations (8)
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1
Silisian Medical University
Katowice-Ligota, Katowice-Ligota, Poland, 40-752
2
Jagiellonian University of Medicine
Krakow, Krakow, Poland, 31-066
3
National Tuberculosis and Lung Diseases Research Institute
Warsaw, Warsaw, Poland, 01-138
4
Warsaw University Medical School
Warsaw, Warsaw, Poland, 02-097