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

NCT00634413 | Completed Phase 2

• 1 other identifier: ADC_4022_CLIN_02P
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 8

Brief 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

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples

  Baseline and after 4 weeks treatment

Secondary Outcomes (3)

• Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum

  Baseline and after 4 weeks treatment

• Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy

  Baseline and after 4 weeks treatment

• Tolerability to ADC4022

  Baseline, during 4 weeks treatment and after 1 week of follow-up

Study Arms (2)

1

EXPERIMENTAL

Drug: Theophylline - ADC4022; Drug: Budesonide

2

PLACEBO COMPARATOR

Drug: Placebo; Drug: Budesonide

Interventions

Theophylline - ADC4022 DRUG

Inhaled theophylline (ADC4022) administered twice daily for 28 days

Also known as: ADC4022

1

Placebo DRUG

Inhaled matching placebo administered twice daily for 28 days

2

Budesonide DRUG

Inhaled budesonide twice daily for 28 days

Also known as: Pulmicort

1; 2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulmagen Therapeutics: lead

Study Sites (8)

Silisian Medical University

Katowice-Ligota, Katowice-Ligota, 40-752, Poland

Location

Jagiellonian University of Medicine

Krakow, Krakow, 31-066, Poland

Location

National Tuberculosis and Lung Diseases Research Institute

Warsaw, Warsaw, 01-138, Poland

Location

Warsaw University Medical School

Warsaw, Warsaw, 02-097, Poland

Location

Medical University in Lodz

Lodz, Łódź Voivodeship, 90-153, Poland

Location

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

The London Chest Hospital

London, London, E2 9JX, United Kingdom

Location

Medicines Evaluation Unit

Manchester, Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Neil Barnes, MD PhD

  London Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: March 2, 2009

Record last verified: 2009-02

Locations

PL (5); GB (3)