Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
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.
Interventions
DRUGTheophylline - ADC4022
Inhaled theophylline (ADC4022) administered twice daily for 28 days
DRUGPlacebo
Inhaled matching placebo administered twice daily for 28 days
DRUGBudesonide
Inhaled budesonide twice daily for 28 days
Sponsors
Pulmagen Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples | Baseline and after 4 weeks treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Poland, United Kingdom
Outcome results
None listed