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| Name | Class |
|---|---|
| Grifols Therapeutics LLC | INDUSTRY |
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This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin dispersion for inhalation | Experimental | Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin |
|
| Placebo | Placebo Comparator | Liquid formulation of empty liposomes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin dispersion for inhalation | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first exacerbation | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of exacerbations | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peoria | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32554534 | Derived | Chalmers JD, Cipolla D, Thompson B, Davis AM, O'Donnell A, Tino G, Gonda I, Haworth C, Froehlich J. Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies. Eur Respir J. 2020 Oct 22;56(4):2000110. doi: 10.1183/13993003.00110-2020. Print 2020 Oct. | |
| 30658914 |
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| Placebo | Drug |
|
|
| Phoenix |
| Arizona |
| United States |
| Downey | California | United States |
| Los Angeles | California | United States |
| Poway | California | United States |
| Farmington | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Celebration | Florida | United States |
| Kissimmee | Florida | United States |
| Miami | Florida | United States |
| Sebring | Florida | United States |
| Kailua | Hawaii | United States |
| Chicago | Illinois | United States |
| Columbia | Maryland | United States |
| Royal Oak | Michigan | United States |
| Rochester | Minnesota | United States |
| Lincoln | Nebraska | United States |
| Cedar Knolls | New Jersey | United States |
| New Hyde Park | New York | United States |
| New York | New York | United States |
| Syracuse | New York | United States |
| Charlotte | North Carolina | United States |
| Huntersville | North Carolina | United States |
| Oklahoma City | Oklahoma | United States |
| Anderson | South Carolina | United States |
| Charleston | South Carolina | United States |
| Columbia | South Carolina | United States |
| Fort Worth | Texas | United States |
| Tyler | Texas | United States |
| Falls Church | Virginia | United States |
| Concord | New South Wales | Australia |
| Westmead | New South Wales | Australia |
| Brisbane | Queensland | Australia |
| Cairns | Queensland | Australia |
| South Brisbane | Queensland | Australia |
| Daw Park | South Australia | Australia |
| Footscray | Victoria | Australia |
| Heidelberg | Victoria | Australia |
| Adelaide | Australia |
| Calgary | Alberta | Canada |
| Kelowna | British Columbia | Canada |
| Montreal | Quebec | Canada |
| Borstel | Schleswig-Holstein | Germany |
| Berlin | Germany |
| Donaustaff | Germany |
| Freiburg im Breisgau | Germany |
| Hanover | Germany |
| Immenstadt im Allgäu | Germany |
| Lübeck | Germany |
| Munich | Germany |
| Budapest | Hungary |
| Debrecen | Hungary |
| Miskolc | Hungary |
| Szombathely | Hungary |
| Dublin | Ireland |
| Galway | Ireland |
| Ashkelon | Israel |
| Haifa | Israel |
| Holon | Israel |
| Jerusalem | Israel |
| Kfar Saba | Israel |
| Rehovot | Israel |
| Tel Aviv | Israel |
| Pavia | PV | Italy |
| Acquaviva delle Fonti | Italy |
| Bologna | Italy |
| Ferrara | Italy |
| Florence | Italy |
| Milan | Italy |
| Pisa | Italy |
| Cekule | Latvia |
| Daugavpils | Latvia |
| Liepāja | Latvia |
| Riga | Latvia |
| Bialystok | Poland |
| Chrzanów | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Bucharest | Romania |
| Constanța | Romania |
| Timișoara | Romania |
| Durban | KwaZulu-Natal | South Africa |
| Pietermaritzburg | KwaZulu-Natal | South Africa |
| Cape Town | South Africa |
| eManzimtoti | South Africa |
| Krugersdorp | South Africa |
| Busan | South Korea |
| Seoul | South Korea |
| Palma de Mallorca | Balearic Islands | Spain |
| Barcelona | Spain |
| Girona | Spain |
| Madrid | Spain |
| Málaga | Spain |
| Kaohsiung City | Taiwan |
| Taichung | Taiwan |
| Taipei | Taiwan |
| Glasgow | Scotland | United Kingdom |
| Birmingham | West Midlands | United Kingdom |
| Bradford | United Kingdom |
| Dundee | United Kingdom |
| Liverpool | United Kingdom |
| Llandough | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Nottinghamshire | United Kingdom |
| Stoke-on-Trent | United Kingdom |
| Tyne and Wear | United Kingdom |
| Wolverhampton | United Kingdom |
| Haworth CS, Bilton D, Chalmers JD, Davis AM, Froehlich J, Gonda I, Thompson B, Wanner A, O'Donnell AE. Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials. Lancet Respir Med. 2019 Mar;7(3):213-226. doi: 10.1016/S2213-2600(18)30427-2. Epub 2019 Jan 15. |
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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