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Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD
This study has been completed.
First Received: March 6, 2008   Last Updated: February 27, 2009   History of Changes
Sponsored by: Argenta Discovery Ltd
Information provided by: Argenta Discovery Ltd
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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Theophylline Budesonide Theophylline sodium glycinate
U.S. FDA Resources
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

Further study details as provided by Argenta Discovery Ltd:

Primary Outcome Measures:
  • Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples [ Time Frame: Baseline and after 4 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum [ Time Frame: Baseline and after 4 weeks treatment ] [ Designated as safety issue: No ]
  • Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy [ Time Frame: Baseline and after 4 weeks treatment ] [ Designated as safety issue: No ]
  • Tolerability to ADC4022 [ Time Frame: Baseline, during 4 weeks treatment and after 1 week of follow-up ] [ Designated as safety issue: Yes ]

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
2: Placebo Comparator Drug: Placebo
Inhaled matching placebo administered twice daily for 28 days
Drug: Budesonide
Inhaled budesonide twice daily for 28 days

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634413

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
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
Sponsors and Collaborators
Argenta Discovery Ltd
Investigators
Principal Investigator: Neil Barnes, MD PhD London Chest Hospital
  More Information

No publications provided

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

Keywords provided by Argenta Discovery Ltd:
COPD

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009