NCT00634413

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Pulmagen Therapeutics · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-03-13
• Last updated: 2009-03-02

Locations

8 sites across 2 countries: Poland, United Kingdom