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

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 Bronchiectasis, non-CF, Ciprofloxacin, Liposome

Eligibility Criteria

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

Inclusion Criteria:

  • Verified bronchiectasis diagnosis
  • Pseudomonas aeruginosa lung infection

Exclusion Criteria:

  • Cystic Fibrosis

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 exacerbation

Secondary Outcome Measures

Number of exacerbations

Full Information

First Posted
January 10, 2012
Last Updated
March 23, 2021
Sponsor
Aradigm Corporation
Collaborators
Grifols Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01515007
Brief Title
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2014 (Actual)
Primary Completion Date
August 17, 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
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Cystic Fibrosis Bronchiectasis
Keywords
Bronchiectasis, non-CF, Ciprofloxacin, Liposome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (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
Other Intervention Name(s)
Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Liquid formulation of empty liposomes
Primary Outcome Measure Information:
Title
Time to first exacerbation
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Number of exacerbations
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Verified bronchiectasis diagnosis Pseudomonas aeruginosa lung infection Exclusion Criteria: Cystic Fibrosis
Facility Information:
City
Peoria
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Downey
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Poway
State/Province
California
Country
United States
City
Farmington
State/Province
Connecticut
Country
United States
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Washington
State/Province
District of Columbia
Country
United States
City
Celebration
State/Province
Florida
Country
United States
City
Kissimmee
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Sebring
State/Province
Florida
Country
United States
City
Kailua
State/Province
Hawaii
Country
United States
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Chicago
State/Province
Illinois
Country
United States
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Columbia
State/Province
Maryland
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
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Lincoln
State/Province
Nebraska
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United States
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Cedar Knolls
State/Province
New Jersey
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United States
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New Hyde Park
State/Province
New York
Country
United States
City
New York
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New York
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United States
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Syracuse
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New York
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United States
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Charlotte
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North Carolina
Country
United States
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Huntersville
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North Carolina
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United States
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Oklahoma City
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Oklahoma
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United States
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Anderson
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South Carolina
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United States
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Charleston
State/Province
South Carolina
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United States
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Columbia
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South Carolina
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United States
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Fort Worth
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Texas
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United States
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Tyler
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Texas
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United States
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Falls Church
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Virginia
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United States
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Concord
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New South Wales
Country
Australia
City
Westmead
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New South Wales
Country
Australia
City
Brisbane
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Queensland
Country
Australia
City
Cairns
State/Province
Queensland
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Australia
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South Brisbane
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Queensland
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Australia
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Daw Park
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South Australia
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Australia
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Footscray
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Victoria
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Australia
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Heidelberg
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Victoria
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Australia
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Adelaide
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Australia
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Calgary
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Alberta
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Canada
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Kelowna
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British Columbia
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Canada
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Montreal
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Quebec
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Canada
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Borstel
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Donaustaff
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Immenstadt im Allgau
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Germany
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Lubeck
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Germany
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Munich
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Germany
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Budapest
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Hungary
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Debrecen
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Hungary
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Miskolc
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Hungary
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Szombathely
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Hungary
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Dublin
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Ireland
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Galway
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Ireland
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Ashkelon
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Kfar-Saba
Country
Israel
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Rehovot
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Israel
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Tel Aviv
Country
Israel
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Pavia
State/Province
PV
Country
Italy
City
Acquaviva delle Fonti
Country
Italy
City
Bologna
Country
Italy
City
Ferrara
Country
Italy
City
Firenze
Country
Italy
City
Milano
Country
Italy
City
Pisa
Country
Italy
City
Busan
Country
Korea, Republic of
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Seoul
Country
Korea, Republic of
City
Cekule
Country
Latvia
City
Daugavpils
Country
Latvia
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Liepaja
Country
Latvia
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Riga
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Latvia
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Bialystok
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Poland
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Chrzanow
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Poland
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Warsaw
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Poland
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Wroclaw
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Poland
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Bucuresti
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Romania
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Constanta
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Romania
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Timisoara
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Romania
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Durban
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KwaZulu-Natal
Country
South Africa
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Pietermaritzburg
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KwaZulu-Natal
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South Africa
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Amanzimtoti
Country
South Africa
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Cape Town
Country
South Africa
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Krugersdorp
Country
South Africa
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Palma de Mallorca
State/Province
Islas Baleares
Country
Spain
City
Barcelona
Country
Spain
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Girona
Country
Spain
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Madrid
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Spain
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Malaga
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Spain
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Taipei City
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Taiwan
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Glasgow
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Scotland
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United Kingdom
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Birmingham
State/Province
West Midlands
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United Kingdom
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Bradford
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United Kingdom
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Dundee
Country
United Kingdom
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Liverpool
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United Kingdom
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Llandough
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Nottinghamshire
Country
United Kingdom
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Stoke-on-Trent
Country
United Kingdom
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Tyne And Wear
Country
United Kingdom
City
Wolverhampton
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-3)

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