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

March 23, 2021 updated by: Aradigm Corporation

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)

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Adelaide, Australia
    • New South Wales
      • Concord, New South Wales, Australia
      • Westmead, New South Wales, Australia
    • Queensland
      • Brisbane, Queensland, Australia
      • Cairns, Queensland, Australia
      • South Brisbane, Queensland, Australia
    • South Australia
      • Daw Park, South Australia, Australia
    • Victoria
      • Footscray, Victoria, Australia
      • Heidelberg, Victoria, Australia
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Berlin, Germany
      • Donaustaff, Germany
      • Freiburg, Germany
      • Hannover, Germany
      • Immenstadt im Allgau, Germany
      • Lubeck, Germany
      • Munich, Germany
    • Schleswig-Holstein
      • Borstel, Schleswig-Holstein, 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
      • Acquaviva delle Fonti, Italy
      • Bologna, Italy
      • Ferrara, Italy
      • Firenze, Italy
      • Milano, Italy
      • Pisa, Italy
    • PV
      • Pavia, PV, Italy
      • Busan, Korea, Republic of
      • Seoul, Korea, Republic of
      • Cekule, Latvia
      • Daugavpils, Latvia
      • Liepaja, Latvia
      • Riga, Latvia
      • Bialystok, Poland
      • Chrzanow, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
      • Bucuresti, Romania
      • Constanta, Romania
      • Timisoara, Romania
      • Amanzimtoti, South Africa
      • Cape Town, South Africa
      • Krugersdorp, South Africa
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa
      • Pietermaritzburg, KwaZulu-Natal, South Africa
      • Barcelona, Spain
      • Girona, Spain
      • Madrid, Spain
      • Malaga, Spain
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain
      • Kaohsiung, Taiwan
      • Taichung City, Taiwan
      • Taipei City, Taiwan
      • 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
    • Scotland
      • Glasgow, Scotland, United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
    • Arizona
      • Peoria, Arizona, United States
      • Phoenix, Arizona, United States
    • California
      • Downey, California, United States
      • Los Angeles, California, United States
      • Poway, California, United States
    • Connecticut
      • Farmington, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Celebration, Florida, United States
      • Kissimmee, Florida, United States
      • Miami, Florida, United States
      • Sebring, Florida, United States
    • Hawaii
      • Kailua, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
    • Maryland
      • Columbia, Maryland, United States
    • Michigan
      • Royal Oak, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New Jersey
      • Cedar Knolls, New Jersey, United States
    • New York
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Huntersville, North Carolina, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
    • Texas
      • Fort Worth, Texas, United States
      • Tyler, Texas, United States
    • Virginia
      • Falls Church, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Verified bronchiectasis diagnosis
  • Pseudomonas aeruginosa lung infection

Exclusion Criteria:

  • Cystic Fibrosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ciprofloxacin dispersion for inhalation
Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Other Names:
  • Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
PLACEBO_COMPARATOR: Placebo
Liquid formulation of empty liposomes
Other Names:
  • Liquid formulation of empty liposomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first exacerbation
Time Frame: One Year
One Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of exacerbations
Time Frame: One Year
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 31, 2014

Primary Completion (ACTUAL)

August 17, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (ESTIMATE)

January 23, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Cystic Fibrosis Bronchiectasis

Clinical Trials on Placebo

Subscribe