Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theophylline - ADC4022 | Drug | Inhaled theophylline (ADC4022) administered twice daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples | Baseline and after 4 weeks treatment |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may also apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neil Barnes, MD PhD | London Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silisian Medical University | Katowice-Ligota | Katowice-Ligota | 40-752 | Poland | ||
| Jagiellonian University of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Inhaled matching placebo administered twice daily for 28 days |
|
| Budesonide | Drug | Inhaled budesonide twice daily for 28 days |
|
|
| Tolerability to ADC4022 | Baseline, during 4 weeks treatment and after 1 week of follow-up |
| Krakow |
| Krakow |
| 31-066 |
| Poland |
| National Tuberculosis and Lung Diseases Research Institute | Warsaw | Warsaw | 01-138 | Poland |
| Warsaw University Medical School | Warsaw | Warsaw | 02-097 | Poland |
| Medical University in Lodz | Lodz | Łódź Voivodeship | 90-153 | Poland |
| Glenfield Hospital | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| The London Chest Hospital | London | London | E2 9JX | United Kingdom |
| Medicines Evaluation Unit | Manchester | Manchester | M23 9QZ | United Kingdom |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided