Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Theophylline - ADC4022 (Drug); Placebo (Drug); Budesonide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Argenta Discovery Ltd

Official(s) and/or principal investigator(s):
Neil Barnes, MD PhD, Principal Investigator, Affiliation: London Chest Hospital

Overall contact:
Product Development, Phone: +44 1279 645645, Email: trials@argentadiscovery.com

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.

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

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

Primary outcome: Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples

Secondary outcome:

Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum

Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy

Tolerability to ADC4022

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

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

Product Development, Phone: +44 1279 645645, Email: trials@argentadiscovery.com

Silisian Medical University, Katowice-Ligota 40-752, Poland; Recruiting

Jagiellonian University of Medicine, Krakow 31-066, Poland; Recruiting

Medical University in Lodz, Lodz 90-153, Poland; Recruiting

Warsaw University Medical School, Warsaw 02-097, Poland; Recruiting

National Tuberculosis and Lung Diseases Research Institute, Warsaw 01-138, Poland; Recruiting

The London Chest Hospital, London E2 9JX, United Kingdom; Not yet recruiting

Medicines Evaluation Unit, Manchester M23 9QZ, United Kingdom; Recruiting

Glenfield Hospital, Leicester, Leicestershire LE3 9QP, United Kingdom; Recruiting

Starting date: February 2008
Ending date: July 2008
Last updated: March 7, 2008