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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022671-60 | EudraCT Number |
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Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid API | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CR002 Liquid API | Biological | A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse events | 44 Days (Day -21 to Day 22) |
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Inclusion Criteria:
Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:
Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Program director Clinical R&D | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 11 | Sofia | Bulgaria | ||||
| Site 12 |
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| Placebo | Biological | A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System. |
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| Varna |
| Bulgaria |
| Site 30 | Debrecen | Hungary |
| Site 24 | Bialystok | Poland |
| Site 22 | Gdansk | Poland |
| Site 21 | Poznan | Poland |
| Site 20 | Rabka-Zdrój | Poland |
| Site 23 | Warsaw | Poland |
| Site 42 | Papworth Hospital | United Kingdom |
| Site 40 | Penarth | United Kingdom |
| Site 41 | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| 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 |
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