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

NCT00634413 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2009-03-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Theophylline - ADC4022

Inhaled theophylline (ADC4022) administered twice daily for 28 days

DRUG

Placebo

Inhaled matching placebo administered twice daily for 28 days

DRUG

Budesonide

Inhaled budesonide twice daily for 28 days

Sponsors & Collaborators

  • Pulmagen Therapeutics

    lead INDUSTRY

Principal Investigators

  • Neil Barnes, MD PhD · London Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634413 on ClinicalTrials.gov