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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Theophylline - ADC4022

Intervention Type DRUG

Inhaled theophylline (ADC4022) administered twice daily for 28 days

Budesonide

Intervention Type DRUG

Inhaled budesonide twice daily for 28 days

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inhaled matching placebo administered twice daily for 28 days

Budesonide

Intervention Type DRUG

Inhaled budesonide twice daily for 28 days

Interventions

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Theophylline - ADC4022

Inhaled theophylline (ADC4022) administered twice daily for 28 days

Intervention Type DRUG

Placebo

Inhaled matching placebo administered twice daily for 28 days

Intervention Type DRUG

Budesonide

Inhaled budesonide twice daily for 28 days

Intervention Type DRUG

Other Intervention Names

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ADC4022 Pulmicort

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No