Clinical trial NCT00634413: Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Pulmagen Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 91
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) when co-administered with budesonide and compared to placebo.


Eligibility 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

Primary outcomes:
measure: Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples
timeFrame: Baseline and after 4 weeks treatment
Secondary outcomes:
measure: Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum
timeFrame: Baseline and after 4 weeks treatment
measure: Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy
timeFrame: Baseline and after 4 weeks treatment
measure: Tolerability to ADC4022
timeFrame: Baseline, during 4 weeks treatment and after 1 week of follow-up
Other outcomes:
Locations:
city: Katowice-Ligota
country: Poland
facility: Silisian Medical University
city: Krakow
country: Poland
facility: Jagiellonian University of Medicine
city: Lodz
country: Poland
facility: Medical University in Lodz
city: Warsaw
country: Poland
facility: National Tuberculosis and Lung Diseases Research Institute
city: Warsaw
country: Poland
facility: Warsaw University Medical School
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: Leicestershire
city: London
country: United Kingdom
facility: The London Chest Hospital
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: London Chest Hospital
name: Neil Barnes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: