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

February 27, 2009 updated by: Pulmagen Therapeutics

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Katowice-Ligota, Poland, 40-752
        • Silisian Medical University
      • Krakow, Poland, 31-066
        • Jagiellonian University of Medicine
      • Lodz, Poland, 90-153
        • Medical University in Lodz
      • Warsaw, Poland, 01-138
        • National Tuberculosis and Lung Diseases Research Institute
      • Warsaw, Poland, 02-097
        • Warsaw University Medical School
  • United Kingdom
      • London, United Kingdom, E2 9JX
        • The London Chest Hospital
      • Manchester, United Kingdom, M23 9QZ
        • Medicines Evaluation Unit
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE3 9QP
        • Glenfield Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Theophylline - ADC4022
Inhaled theophylline (ADC4022) administered twice daily for 28 days
Other Names:
  • ADC4022
Drug: Budesonide
Inhaled budesonide twice daily for 28 days
Other Names:
  • Pulmicort
Placebo Comparator: 2
Drug: Budesonide
Inhaled budesonide twice daily for 28 days
Other Names:
  • Pulmicort
Drug: Placebo
Inhaled matching placebo administered twice daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples
Time Frame: Baseline and after 4 weeks treatment
Baseline and after 4 weeks treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum
Time Frame: Baseline and after 4 weeks treatment
Baseline and after 4 weeks treatment
Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy
Time Frame: Baseline and after 4 weeks treatment
Baseline and after 4 weeks treatment
Tolerability to ADC4022
Time Frame: Baseline, during 4 weeks treatment and after 1 week of follow-up
Baseline, during 4 weeks treatment and after 1 week of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmagen Therapeutics

Investigators

  • Principal Investigator: Neil Barnes, MD PhD, London Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 2, 2009

Last Update Submitted That Met QC Criteria

February 27, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADC_4022_CLIN_02P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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