Trial | NCT00634413  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    91
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 Started
Feb 29
2008
Primary Completion
Dec 31
2008
Study Completion
Jan 31
2009
Last Update
Mar 02
2009
Estimate

Drug Theophylline - ADC4022

Inhaled theophylline (ADC4022) administered twice daily for 28 days

  • Other names: ADC4022

Drug Placebo

Inhaled matching placebo administered twice daily for 28 days

Drug Budesonide

Inhaled budesonide twice daily for 28 days

  • Other names: Pulmicort

1 Experimental

2 Placebo Comparator

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
No Results Posted