Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

• Sponsor: Aradigm Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02104245
• Collaborator: Grifols Therapeutics LLC (Industry)
• Enrollment: 304
• Locations: 95
• Arms: 2
• Actual Duration (Months): 28.2
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study (ARD-3150-1202, ORBIT-4) 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
Non Cystic Fibrosis Bronchiectasis	Drug: Ciprofloxacin dispersion for inhalation; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
• Actual Study Start Date: May 28, 2014
• Actual Primary Completion Date: Aug 11, 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
Placebo Comparator: Placebo Liquid formulation of empty liposomes	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Time to first pulmonary exacerbation (from baseline) [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmed diagnosis of non-CF bronchiectasis

• History of P. aeruginosa respiratory infections

• At least two pulmonary exacerbations treated with antibiotics in the previous year

Exclusion Criteria:

• Have a clinical diagnosis of CF

• Are pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Scottsdale	Arizona	United States
3		Sacramento	California	United States
4		San Diego	California	United States
5		Torrance	California	United States
6		Danbury	Connecticut	United States
7		Miami	Florida	United States
8		Orlando	Florida	United States
9		Winter Park	Florida	United States
10		Decatur	Georgia	United States
11		Duluth	Georgia	United States
12		Port Huron	Michigan	United States
13		Omaha	Nebraska	United States
14		Lebanon	New Hampshire	United States
15		Summit	New Jersey	United States
16		Albuquerque	New Mexico	United States
17		New York	New York	United States
18		Chapel Hill	North Carolina	United States
19		Columbus	Ohio	United States
20		Philadelphia	Pennsylvania	United States
21		Rock Hill	South Carolina	United States
22		Spartanburg	South Carolina	United States
23		Tyler	Texas	United States
24		Seattle	Washington	United States
25		Milwaukee	Wisconsin	United States
26		Greenslopes	Queensland	Australia
27		Adelaide	South Australia	Australia
28		Nedlands	Western Australia	Australia
29		Perth	Western Australia	Australia
30		Vancouver	British Columbia	Canada
31		Toronto	Ontario	Canada
32		Windsor	Ontario	Canada
33		St-Jerome	Quebec	Canada
34		Belgrade		Former Serbia and Montenegro
35		Knez Selo		Former Serbia and Montenegro
36		Kragujevac		Former Serbia and Montenegro
37		Sremska Kamenica		Former Serbia and Montenegro
38		Créteil Cedex 01		France
39		Grenoble cedex		France
40		Nice Cedex 1		France
41		Pessac Cedex		France
42		Rouen Cedex		France
43		Toulouse cedex 9		France
44		Kutaisi		Georgia
45		Tbilisi		Georgia
46		Budapest		Hungary
47		Nyiregyhaza		Hungary
48		Szekesfehervar		Hungary
49		Torokbalint		Hungary
50		Jerusalem		Israel
51		Petach Tikva		Israel
52		Ramat Gan		Israel
53		Tel-Aviv		Israel
54		Avellino		Italy
55		Napoli		Italy
56		Parma		Italy
57		Pisa		Italy
58		San Gerardo		Italy
59		Terni		Italy
60		Trieste		Italy
61		Suwon	Gyeonggi-do	Korea, Republic of
62		Daegu		Korea, Republic of
63		Seoul		Korea, Republic of
64		Otahuhu	Auckland	New Zealand
65		Hamilton	Waikato	New Zealand
66		Tauranga		New Zealand
67		Jesus Maria	Lima	Peru
68		La Victoria	Lima	Peru
69		Pueblo Libre	Lima	Peru
70		San Juan de Miraflores	Lima	Peru
71		Bialystok		Poland
72		Krakow		Poland
73		Ruda Slaska		Poland
74		Warsaw		Poland
75		Arad		Romania
76		Bucuresti		Romania
77		Cluj-Napoca		Romania
78		Craiova		Romania
79		Iasi		Romania
80		Barcelona		Spain
81		La Coruna		Spain
82		Lleida		Spain
83		Valencia		Spain
84		Stockton-on-Trees	Cleveland	United Kingdom
85		Wigan	Greater Manchester	United Kingdom
86		Cambridge		United Kingdom
87		Colchester		United Kingdom
88		Cottingham		United Kingdom
89		Lancaster		United Kingdom
90		Leeds		United Kingdom
91		London		United Kingdom
92		Manchester		United Kingdom
93		North Sheilds		United Kingdom
94		Southampton		United Kingdom
95		Telford		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: NCT02104245
• Other Study ID Numbers: ARD-3150-1202
• First Posted: Apr 4, 2014
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Aradigm Corporation: Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa
• Additional relevant MeSH terms: Bronchiectasis; Fibrosis; Ciprofloxacin

Study Results

No Results Posted as of Mar 26, 2021