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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000243-87 | EudraCT Number |
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The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.
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This study tests the effects of an experimental drug PC945 in people with cystic fibrosis whose lungs are infected by the fungus Aspergillus fumigatus.
PC945 may be useful in treating patients infected with Aspergillus fumigatus as, unlike the usual treatments, it is inhaled into the lung and has been designed to stay there and treat the infection. Participants will continue to be treated with their usual cystic fibrosis treatment and will also receive PC945. The amount of fungus in the patients' phlegm will be measured over the course of the study. The study will take place at multiple sites in UK and will include approximately 18 participants. The maximum study duration will be about 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PC945 | Experimental | PC945 5mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC945 | Drug | PC945, nebulized |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Baseline to Day 84 | |
| Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose | Baseline to Day 84 | |
| Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose | Baseline to Day 84 | |
| Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose | Baseline to Day 84 | |
| Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values | Baseline to Day 84 | |
| Forced vital capacity (FVC) values | Baseline to Day 84 | |
| Peak expiratory flow rate values (PEFR) | Baseline to Day 84 | |
| Maximum expiratory flow values (MEF25-75) | Baseline to Day 84 | |
| Breathlessness visual analogue scale rating, change over time | Symptom severity rated from "Best ever" to "Worst possible" | Baseline to Day 84 |
| Cough visual analogue scale rating, change over time |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of sputum A. fumigatus colony forming units (CFU) | Baseline to Day 84 | |
| A. fumigatus status (presence or absence) in subjects with a baseline A. fumigatus-positive sputum culture | Day 1 to Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom | |||
| Northwest Lung Research Centre |
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| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D010182 | Pancreatic Diseases |
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Symptom severity rated from "Best ever" to "Worst possible" |
| Baseline to Day 84 |
| Area under the curve from time 0 to 2 h post-dose (AUC0-2) | Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable | Baseline to Day 84 |
| Maximum plasma concentration | Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable | Baseline to Day 84 |
| Concentration at the end of the dosage interval (Ctrough) | Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable | Baseline to Day 84 |
| Change in sputum A. fumigatus measured by quantitative polymerase chain reaction (qPCR) | Baseline to Day 84 |
| Change in the serum concentration of A. fumigatus-specific immunoglobulins G (IgG) | Baseline to Day 84 |
| Change in serum Total immunoglobulin E (IgE) levels | Baseline to Day 84 |
| Change in serum Aspergillus-specific IgE levels | Baseline to Day 84 |
| Correlation between A. fumigatus measured by qPCR and clinical response | Baseline to Day 84 |
| Cystic Fibrosis Questionnaire - Revised (CFQ-R) score | Baseline to Day 84 |
| Sputum consistency, including presence of blood | Categorical variable | Baseline to Day 84 |
| Sputum colour | Categorical variable using standardised colour chart. | Baseline to Day 84 |
| Manchester |
| M23 9LT |
| United Kingdom |
| D004066 |
| Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |