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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634413
• Other study ID #: ADC_4022_CLIN_02P
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2008
• Last updated: February 27, 2009
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Pulmagen Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Theophylline - ADC4022
Inhaled theophylline (ADC4022) administered twice daily for 28 days
• Placebo
Inhaled matching placebo administered twice daily for 28 days
• Budesonide
Inhaled budesonide twice daily for 28 days

Locations

Country	Name	City	State
Poland	Silisian Medical University	Katowice-Ligota
Poland	Jagiellonian University of Medicine	Krakow
Poland	Medical University in Lodz	Lodz
Poland	National Tuberculosis and Lung Diseases Research Institute	Warsaw
Poland	Warsaw University Medical School	Warsaw
United Kingdom	Glenfield Hospital	Leicester	Leicestershire
United Kingdom	The London Chest Hospital	London
United Kingdom	Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Pulmagen Therapeutics

Countries where clinical trial is conducted

Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples		Baseline and after 4 weeks treatment	No
Secondary	Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum		Baseline and after 4 weeks treatment	No
Secondary	Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy		Baseline and after 4 weeks treatment	No
Secondary	Tolerability to ADC4022		Baseline, during 4 weeks treatment and after 1 week of follow-up	Yes