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

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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

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

  • Australia
    • Queensland
      • Greenslopes, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia
    • Western Australia
      • Nedlands, Western Australia, Australia
      • Perth, Western Australia, Australia
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Toronto, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • St-Jerome, Quebec, Canada
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro
      • Knez Selo, Former Serbia and Montenegro
      • Kragujevac, Former Serbia and Montenegro
      • Sremska Kamenica, Former Serbia and Montenegro
  • France
      • Créteil Cedex 01, France
      • Grenoble cedex, France
      • Nice Cedex 1, France
      • Pessac Cedex, France
      • Rouen Cedex, France
      • Toulouse cedex 9, France
  • Georgia
      • Kutaisi, Georgia
      • Tbilisi, Georgia
  • Hungary
      • Budapest, Hungary
      • Nyiregyhaza, Hungary
      • Szekesfehervar, Hungary
      • Torokbalint, Hungary
  • Israel
      • Jerusalem, Israel
      • Petach Tikva, Israel
      • Ramat Gan, Israel
      • Tel-Aviv, Israel
  • Italy
      • Avellino, Italy
      • Napoli, Italy
      • Parma, Italy
      • Pisa, Italy
      • San Gerardo, Italy
      • Terni, Italy
      • Trieste, Italy
  • Korea, Republic of
      • Daegu, Korea, Republic of
      • Seoul, Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of
  • New Zealand
      • Tauranga, New Zealand
    • Auckland
      • Otahuhu, Auckland, New Zealand
    • Waikato
      • Hamilton, Waikato, New Zealand
  • Peru
    • Lima
      • Jesus Maria, Lima, Peru
      • La Victoria, Lima, Peru
      • Pueblo Libre, Lima, Peru
      • San Juan de Miraflores, Lima, Peru
  • Poland
      • Bialystok, Poland
      • Krakow, Poland
      • Ruda Slaska, Poland
      • Warsaw, Poland
  • Romania
      • Arad, Romania
      • Bucuresti, Romania
      • Cluj-Napoca, Romania
      • Craiova, Romania
      • Iasi, Romania
  • Spain
      • Barcelona, Spain
      • La Coruna, Spain
      • Lleida, Spain
      • Valencia, Spain
  • United Kingdom
      • Cambridge, United Kingdom
      • Colchester, United Kingdom
      • Cottingham, United Kingdom
      • Lancaster, United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • North Sheilds, United Kingdom
      • Southampton, United Kingdom
      • Telford, United Kingdom
    • Cleveland
      • Stockton-on-Trees, Cleveland, United Kingdom
    • Greater Manchester
      • Wigan, Greater Manchester, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
    • California
      • Sacramento, California, United States
      • San Diego, California, United States
      • Torrance, California, United States
    • Connecticut
      • Danbury, Connecticut, United States
    • Florida
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Decatur, Georgia, United States
      • Duluth, Georgia, United States
    • Michigan
      • Port Huron, Michigan, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Summit, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Rock Hill, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Texas
      • Tyler, Texas, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, 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:

  • 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

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
Drug: Ciprofloxacin dispersion for inhalation
PLACEBO_COMPARATOR: Placebo
Liquid formulation of empty liposomes
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first pulmonary exacerbation (from baseline)
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

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

Sponsor

Aradigm Corporation

Collaborators

Grifols Therapeutics LLC

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.

General Publications

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)

May 28, 2014

Primary Completion (ACTUAL)

August 11, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (ESTIMATE)

April 4, 2014

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

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARD-3150-1202

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.

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