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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: Theophylline - ADC4022
  • Inhaled theophylline (ADC4022) administered twice daily for 28 days
• Drug: Placebo
  • Inhaled matching placebo administered twice daily for 28 days
• Drug: Budesonide
  • Inhaled budesonide twice daily for 28 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples
  • Time Frame: Baseline and after 4 weeks treatment
    Safety Issue?: No

Secondary Measures

• Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum
  • Time Frame: Baseline and after 4 weeks treatment
    Safety Issue?: No
• Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy
  • Time Frame: Baseline and after 4 weeks treatment
    Safety Issue?: No
• Tolerability to ADC4022
  • Time Frame: Baseline, during 4 weeks treatment and after 1 week of follow-up
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Argenta Discovery Ltd

Overall Clinical Trial Officials and Contacts

Neil Barnes, MD PhD Principal Investigator London Chest Hospital  

Overall Contact: Product Development +44 1279 645645 trials@argentadiscovery.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634413

Study ID Number: ADC_4022_CLIN_02P

ClinicalTrials.gov Identifier: NCT00634413

Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products