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

Primary Purpose

Non Cystic Fibrosis Bronchiectasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciprofloxacin dispersion for inhalation
Placebo
Sponsored by
Aradigm Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Cystic Fibrosis Bronchiectasis focused on measuring Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ciprofloxacin dispersion for inhalation

Placebo

Arm Description

Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin

Liquid formulation of empty liposomes

Outcomes

Primary Outcome Measures

Time to first pulmonary exacerbation (from baseline)

Secondary Outcome Measures

Full Information

First Posted
March 28, 2014
Last Updated
March 23, 2021
Sponsor
Aradigm Corporation
Collaborators
Grifols Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02104245
Brief Title
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2014 (Actual)
Primary Completion Date
August 11, 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aradigm Corporation
Collaborators
Grifols Therapeutics LLC

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Cystic Fibrosis Bronchiectasis
Keywords
Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ciprofloxacin dispersion for inhalation
Arm Type
Experimental
Arm Description
Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Liquid formulation of empty liposomes
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin dispersion for inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time to first pulmonary exacerbation (from baseline)
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Scottsdale
State/Province
Arizona
Country
United States
City
Sacramento
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California
Country
United States
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San Diego
State/Province
California
Country
United States
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Torrance
State/Province
California
Country
United States
City
Danbury
State/Province
Connecticut
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
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United States
City
Winter Park
State/Province
Florida
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United States
City
Decatur
State/Province
Georgia
Country
United States
City
Duluth
State/Province
Georgia
Country
United States
City
Port Huron
State/Province
Michigan
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
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Lebanon
State/Province
New Hampshire
Country
United States
City
Summit
State/Province
New Jersey
Country
United States
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Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
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Columbus
State/Province
Ohio
Country
United States
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Philadelphia
State/Province
Pennsylvania
Country
United States
City
Rock Hill
State/Province
South Carolina
Country
United States
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Spartanburg
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South Carolina
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United States
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Tyler
State/Province
Texas
Country
United States
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Seattle
State/Province
Washington
Country
United States
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Milwaukee
State/Province
Wisconsin
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United States
City
Greenslopes
State/Province
Queensland
Country
Australia
City
Adelaide
State/Province
South Australia
Country
Australia
City
Nedlands
State/Province
Western Australia
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Australia
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Perth
State/Province
Western Australia
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Australia
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Vancouver
State/Province
British Columbia
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Canada
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Toronto
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Ontario
Country
Canada
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Windsor
State/Province
Ontario
Country
Canada
City
St-Jerome
State/Province
Quebec
Country
Canada
City
Belgrade
Country
Former Serbia and Montenegro
City
Knez Selo
Country
Former Serbia and Montenegro
City
Kragujevac
Country
Former Serbia and Montenegro
City
Sremska Kamenica
Country
Former Serbia and Montenegro
City
Créteil Cedex 01
Country
France
City
Grenoble cedex
Country
France
City
Nice Cedex 1
Country
France
City
Pessac Cedex
Country
France
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Rouen Cedex
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France
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Toulouse cedex 9
Country
France
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Kutaisi
Country
Georgia
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Tbilisi
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Georgia
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Budapest
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Hungary
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Nyiregyhaza
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Hungary
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Szekesfehervar
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Hungary
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Torokbalint
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Hungary
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel-Aviv
Country
Israel
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Avellino
Country
Italy
City
Napoli
Country
Italy
City
Parma
Country
Italy
City
Pisa
Country
Italy
City
San Gerardo
Country
Italy
City
Terni
Country
Italy
City
Trieste
Country
Italy
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Otahuhu
State/Province
Auckland
Country
New Zealand
City
Hamilton
State/Province
Waikato
Country
New Zealand
City
Tauranga
Country
New Zealand
City
Jesus Maria
State/Province
Lima
Country
Peru
City
La Victoria
State/Province
Lima
Country
Peru
City
Pueblo Libre
State/Province
Lima
Country
Peru
City
San Juan de Miraflores
State/Province
Lima
Country
Peru
City
Bialystok
Country
Poland
City
Krakow
Country
Poland
City
Ruda Slaska
Country
Poland
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Warsaw
Country
Poland
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Arad
Country
Romania
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Bucuresti
Country
Romania
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Cluj-Napoca
Country
Romania
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Craiova
Country
Romania
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Iasi
Country
Romania
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Barcelona
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Spain
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La Coruna
Country
Spain
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Lleida
Country
Spain
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Valencia
Country
Spain
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Stockton-on-Trees
State/Province
Cleveland
Country
United Kingdom
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Wigan
State/Province
Greater Manchester
Country
United Kingdom
City
Cambridge
Country
United Kingdom
City
Colchester
Country
United Kingdom
City
Cottingham
Country
United Kingdom
City
Lancaster
Country
United Kingdom
City
Leeds
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
North Sheilds
Country
United Kingdom
City
Southampton
Country
United Kingdom
City
Telford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32554534
Citation
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.
Results Reference
derived
PubMed Identifier
30658914
Citation
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. Erratum In: Lancet Respir Med. 2019 Jan 25;:
Results Reference
derived

Learn more about this trial

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

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