Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
Sponsor
Aradigm Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01515007
Collaborator
Grifols Therapeutics LLC (Industry)
278
109
2
30.1
2.6
0.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
278 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)
Actual Study Start Date
:
Mar 31, 2014
Actual Primary Completion Date
:
Aug 17, 2016
Actual Study Completion Date
:
Oct 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ciprofloxacin dispersion for inhalation Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin |
Drug: Ciprofloxacin dispersion for inhalation
Other Names:
|
| Placebo Comparator: Placebo Liquid formulation of empty liposomes |
Drug: Placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time to first exacerbation [One Year]
Secondary Outcome Measures
- Number of exacerbations [One Year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Verified bronchiectasis diagnosis
-
Pseudomonas aeruginosa lung infection
Exclusion Criteria:
- Cystic Fibrosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peoria | Arizona | United States | ||
| 2 | Phoenix | Arizona | United States | ||
| 3 | Downey | California | United States | ||
| 4 | Los Angeles | California | United States | ||
| 5 | Poway | California | United States | ||
| 6 | Farmington | Connecticut | United States | ||
| 7 | Washington | District of Columbia | United States | ||
| 8 | Celebration | Florida | United States | ||
| 9 | Kissimmee | Florida | United States | ||
| 10 | Miami | Florida | United States | ||
| 11 | Sebring | Florida | United States | ||
| 12 | Kailua | Hawaii | United States | ||
| 13 | Chicago | Illinois | United States | ||
| 14 | Columbia | Maryland | United States | ||
| 15 | Royal Oak | Michigan | United States | ||
| 16 | Rochester | Minnesota | United States | ||
| 17 | Lincoln | Nebraska | United States | ||
| 18 | Cedar Knolls | New Jersey | United States | ||
| 19 | New Hyde Park | New York | United States | ||
| 20 | New York | New York | United States | ||
| 21 | Syracuse | New York | United States | ||
| 22 | Charlotte | North Carolina | United States | ||
| 23 | Huntersville | North Carolina | United States | ||
| 24 | Oklahoma City | Oklahoma | United States | ||
| 25 | Anderson | South Carolina | United States | ||
| 26 | Charleston | South Carolina | United States | ||
| 27 | Columbia | South Carolina | United States | ||
| 28 | Fort Worth | Texas | United States | ||
| 29 | Tyler | Texas | United States | ||
| 30 | Falls Church | Virginia | United States | ||
| 31 | Concord | New South Wales | Australia | ||
| 32 | Westmead | New South Wales | Australia | ||
| 33 | Brisbane | Queensland | Australia | ||
| 34 | Cairns | Queensland | Australia | ||
| 35 | South Brisbane | Queensland | Australia | ||
| 36 | Daw Park | South Australia | Australia | ||
| 37 | Footscray | Victoria | Australia | ||
| 38 | Heidelberg | Victoria | Australia | ||
| 39 | Adelaide | Australia | |||
| 40 | Calgary | Alberta | Canada | ||
| 41 | Kelowna | British Columbia | Canada | ||
| 42 | Montreal | Quebec | Canada | ||
| 43 | Borstel | Schleswig-Holstein | Germany | ||
| 44 | Berlin | Germany | |||
| 45 | Donaustaff | Germany | |||
| 46 | Freiburg | Germany | |||
| 47 | Hannover | Germany | |||
| 48 | Immenstadt im Allgau | Germany | |||
| 49 | Lubeck | Germany | |||
| 50 | Munich | Germany | |||
| 51 | Budapest | Hungary | |||
| 52 | Debrecen | Hungary | |||
| 53 | Miskolc | Hungary | |||
| 54 | Szombathely | Hungary | |||
| 55 | Dublin | Ireland | |||
| 56 | Galway | Ireland | |||
| 57 | Ashkelon | Israel | |||
| 58 | Haifa | Israel | |||
| 59 | Holon | Israel | |||
| 60 | Jerusalem | Israel | |||
| 61 | Kfar-Saba | Israel | |||
| 62 | Rehovot | Israel | |||
| 63 | Tel Aviv | Israel | |||
| 64 | Pavia | PV | Italy | ||
| 65 | Acquaviva delle Fonti | Italy | |||
| 66 | Bologna | Italy | |||
| 67 | Ferrara | Italy | |||
| 68 | Firenze | Italy | |||
| 69 | Milano | Italy | |||
| 70 | Pisa | Italy | |||
| 71 | Busan | Korea, Republic of | |||
| 72 | Seoul | Korea, Republic of | |||
| 73 | Cekule | Latvia | |||
| 74 | Daugavpils | Latvia | |||
| 75 | Liepaja | Latvia | |||
| 76 | Riga | Latvia | |||
| 77 | Bialystok | Poland | |||
| 78 | Chrzanow | Poland | |||
| 79 | Warsaw | Poland | |||
| 80 | Wroclaw | Poland | |||
| 81 | Bucuresti | Romania | |||
| 82 | Constanta | Romania | |||
| 83 | Timisoara | Romania | |||
| 84 | Durban | KwaZulu-Natal | South Africa | ||
| 85 | Pietermaritzburg | KwaZulu-Natal | South Africa | ||
| 86 | Amanzimtoti | South Africa | |||
| 87 | Cape Town | South Africa | |||
| 88 | Krugersdorp | South Africa | |||
| 89 | Palma de Mallorca | Islas Baleares | Spain | ||
| 90 | Barcelona | Spain | |||
| 91 | Girona | Spain | |||
| 92 | Madrid | Spain | |||
| 93 | Malaga | Spain | |||
| 94 | Kaohsiung | Taiwan | |||
| 95 | Taichung City | Taiwan | |||
| 96 | Taipei City | Taiwan | |||
| 97 | Glasgow | Scotland | United Kingdom | ||
| 98 | Birmingham | West Midlands | United Kingdom | ||
| 99 | Bradford | United Kingdom | |||
| 100 | Dundee | United Kingdom | |||
| 101 | Liverpool | United Kingdom | |||
| 102 | Llandough | United Kingdom | |||
| 103 | London | United Kingdom | |||
| 104 | Manchester | United Kingdom | |||
| 105 | Newcastle upon Tyne | United Kingdom | |||
| 106 | Nottinghamshire | United Kingdom | |||
| 107 | Stoke-on-Trent | United Kingdom | |||
| 108 | Tyne And Wear | United Kingdom | |||
| 109 | Wolverhampton | United Kingdom |
Sponsors and Collaborators
- Aradigm Corporation
- Grifols Therapeutics LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT01515007
Other Study ID Numbers:
- ARD-3150-1201
First Posted:
Jan 23, 2012
Last Update Posted:
Mar 26, 2021
Last Verified:
Mar 1, 2021
Keywords provided by Aradigm Corporation
Additional relevant MeSH terms: