Non Cystic Fibrosis BronchiectasisPhase 3NCT02104245
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
A Phase 3 study testing Ciprofloxacin dispersion for inhalation in people with Non Cystic Fibrosis Bronchiectasis, run by Aradigm Corporation at 95 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Cystic Fibrosis Bronchiectasis
- What is being tested?
- Ciprofloxacin dispersion for inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 95 sitesin 16 countries
- Study dates
- 28 May 2014to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of non-CF bronchiectasis
- History of P. aeruginosa respiratory infections
- At least two pulmonary exacerbations treated with antibiotics in the previous year
Who cannot join
- Have a clinical diagnosis of CF
- Are pregnant
Trial locations and contacts
95 sites in 16 countries.
95 sites in 16 countries
United States25 sites
Study site
Albuquerque, New Mexico
Study site
Chapel Hill, North Carolina
Study site
Columbus, Ohio
Study site
Danbury, Connecticut
Study site
Decatur, Georgia
Study site
Duluth, Georgia
Study site
Lebanon, New Hampshire
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
New York, New York
Study site
Omaha, Nebraska
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Port Huron, Michigan
Study site
Rock Hill, South Carolina
Study site
Sacramento, California
Study site
San Diego, California
Study site
Scottsdale, Arizona
Study site
Seattle, Washington
Study site
Spartanburg, South Carolina
Study site
Summit, New Jersey
Study site
Torrance, California
Study site
Tyler, Texas
Study site
Winter Park, Florida
United Kingdom12 sites
Study site
Cambridge
Study site
Colchester
Study site
Cottingham
Study site
Lancaster
Study site
Leeds
Study site
London
Study site
Manchester
Study site
North Sheilds
Study site
Southampton
Study site
Stockton-on-Trees, Cleveland
Study site
Telford
Study site
Wigan, Greater Manchester
Italy7 sites
Study site
Avellino
Study site
Naples
Study site
Parma
Study site
Pisa
Study site
San Gerardo
Study site
Terni
Study site
Trieste
France6 sites
Study site
Créteil
Study site
Grenoble
Study site
Nice
Study site
Pessac
Study site
Rouen
Study site
Toulouse
Romania5 sites
Study site
Arad
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Craiova
Study site
Iași
Australia4 sites
Study site
Adelaide, South Australia
Study site
Greenslopes, Queensland
Study site
Nedlands, Western Australia
Study site
Perth, Western Australia
Canada4 sites
Study site
Saint-Jérôme, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Windsor, Ontario
Hungary4 sites
Study site
Budapest
Study site
Nyíregyháza
Study site
Székesfehérvár
Study site
Törökbálint
Israel4 sites
Study site
Jerusalem
Study site
Petah Tikva
Study site
Ramat Gan
Study site
Tel Aviv
Peru4 sites
Study site
Jesus Maria, Lima region
Study site
La Victoria, Lima region
Study site
Pueblo Libre, Lima region
Study site
San Juan de Miraflores, Lima region
Poland4 sites
Study site
Bialystok
Study site
Krakow
Study site
Ruda Śląska
Study site
Warsaw
Serbia and Montenegro4 sites
Study site
Belgrade
Study site
Knez Selo
Study site
Kragujevac
Study site
Sremska Kamenica
Spain4 sites
Study site
A Coruña
Study site
Barcelona
Study site
Lleida
Study site
Valencia
New Zealand3 sites
Study site
Hamilton, Waikato Region
Study site
Otahuhu, Auckland
Study site
Tauranga
South Korea3 sites
Study site
Daegu
Study site
Seoul
Study site
Suwon, Gyeonggi-do
About this study
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
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.
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Being tested
- Ciprofloxacin dispersion for inhalation, Placebo
- Keywords
- Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin dispersion for inhalationDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin dispersion for inhalation | Experimental | Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin Receives: Drug: Ciprofloxacin dispersion for inhalation |
| Placebo | Placebo comparator | Liquid formulation of empty liposomes Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first pulmonary exacerbation (from baseline)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start28 May 2014
- Primary completion11 Aug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aradigm Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grifols Therapeutics LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104245
- Sponsor's protocol ID
- ARD-3150-1202
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2014
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32554534Haworth 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.
PubMed 30658914
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02104245
- Acronym / sponsor ID
- ARD-3150-1202
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Keywords
- Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Aradigm CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Grifols Therapeutics LLC
- Study start
- 28 May 2014 (actual)
- Primary completion
- 11 Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin dispersion for inhalation | Experimental | Drug: Ciprofloxacin dispersion for inhalationLiquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin |
| Placebo | Placebo comparator | Drug: PlaceboLiquid formulation of empty liposomes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of non-CF bronchiectasis
- History of P. aeruginosa respiratory infections
- At least two pulmonary exacerbations treated with antibiotics in the previous year
Key exclusion criteria (2 listed)
- Have a clinical diagnosis of CF
- Are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacin dispersion for inhalation | Drug | Ciprofloxacin dispersion for inhalation |
| Placebo | Drug | Placebo |
Primary outcome
Time to first pulmonary exacerbation (from baseline)
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Derived from this study: PubMed 32554534Chalmers 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.
- Derived from this study: PubMed 30658914Haworth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
95 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin dispersion for inhalation in people with Non Cystic Fibrosis Bronchiectasis, run by Aradigm Corporation at 95 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, United Kingdom, Italy, France, Romania and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first pulmonary exacerbation (from baseline) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02104245, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.