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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00634413
Other study ID # ADC_4022_CLIN_02P
Secondary ID
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


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
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