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The purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1236 | Drug | Oral tablet, 75 mg twice daily during 4 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on biomarker levels in induced sputum | 2 times at baseline and after 4 weeks treatment | |
| Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire) | At inclusion, at randomisation and after 4 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (adverse events, vital signs and laboratory safety variables) | throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up) | |
| Effect on biomarkers in blood | 2 times, at baseline and after 4 weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Lockton, MD | AstraZeneca R&D Charnwood | Study Director |
| Shawn Aaron, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Montreal | Canada | ||||
| Research Site |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000713527 | 4-((5-chloro-2-pyridinyl)oxy)-1-((((4S)-4-methyl-2,5-dioxo-4-imidazolidinyl)methyl)sulfonyl)-piperidine |
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| Drug |
|
| Effect on biomarkers in urine | 2 times, at baseline and after 4 weeks treatment |
| Ottawa |
| Canada |
| Research Site | Vancouver | Canada |
| Research Site | Amsterdam | Netherlands |
| Research Site | Groningen | Netherlands |
| Research Site | Utrecht | Netherlands |
| Research Site | Gdansk | Poland |
| Research Site | Poznan | Poland |
| Research Site | Barcelona | Catalonia | Spain |
| Research Site | Madrid | Madrid | Spain |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |