Non Cystic Fibrosis BronchiectasisPhase 3NCT01515007
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
A Phase 3 study testing Ciprofloxacin dispersion for inhalation in people with Non Cystic Fibrosis Bronchiectasis, run by Aradigm Corporation at 109 sites in 16 countries.
Trial 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. 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
- 278 participants
- Where
- 109 sitesin 16 countries
- Study dates
- 31 Mar 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
- Verified bronchiectasis diagnosis
- Pseudomonas aeruginosa lung infection
Who cannot join
- Cystic Fibrosis
Trial locations and contacts
109 sites in 16 countries.
109 sites in 16 countries
United States30 sites
Study site
Anderson, South Carolina
Study site
Cedar Knolls, New Jersey
Study site
Celebration, Florida
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Columbia, Maryland
Study site
Columbia, South Carolina
Study site
Downey, California
Study site
Falls Church, Virginia
Study site
Farmington, Connecticut
Study site
Fort Worth, Texas
Study site
Huntersville, North Carolina
Study site
Kailua, Hawaii
Study site
Kissimmee, Florida
Study site
Lincoln, Nebraska
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
New Hyde Park, New York
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Peoria, Arizona
Study site
Phoenix, Arizona
Study site
Poway, California
Study site
Rochester, Minnesota
Study site
Royal Oak, Michigan
Study site
Sebring, Florida
Study site
Syracuse, New York
Study site
Tyler, Texas
Study site
Washington D.C., District of Columbia
United Kingdom13 sites
Study site
Birmingham, West Midlands
Study site
Bradford
Study site
Dundee
Study site
Glasgow, Scotland
Study site
Liverpool
Study site
Llandough
Study site
London
Study site
Manchester
Study site
Newcastle upon Tyne
Study site
Nottinghamshire
Study site
Stoke-on-Trent
Study site
Tyne and Wear
Study site
Wolverhampton
Australia9 sites
Study site
Adelaide
Study site
Brisbane, Queensland
Study site
Cairns, Queensland
Study site
Concord, New South Wales
Study site
Daw Park, South Australia
Study site
Footscray, Victoria
Study site
Heidelberg, Victoria
Study site
South Brisbane, Queensland
Study site
Westmead, New South Wales
Germany8 sites
Study site
Berlin
Study site
Borstel, Schleswig-Holstein
Study site
Donaustaff
Study site
Freiburg im Breisgau
Study site
Hanover
Study site
Immenstadt im Allgäu
Study site
Lübeck
Study site
Munich
Israel7 sites
Study site
Ashkelon
Study site
Haifa
Study site
Holon
Study site
Jerusalem
Study site
Kfar Saba
Study site
Rehovot
Study site
Tel Aviv
Italy7 sites
Study site
Acquaviva delle Fonti
Study site
Bologna
Study site
Ferrara
Study site
Florence
Study site
Milan
Study site
Pavia, PV
Study site
Pisa
South Africa5 sites
Study site
Cape Town
Study site
Durban, KwaZulu-Natal
Study site
eManzimtoti
Study site
Krugersdorp
Study site
Pietermaritzburg, KwaZulu-Natal
Spain5 sites
Study site
Barcelona
Study site
Girona
Study site
Madrid
Study site
Málaga
Study site
Palma de Mallorca, Balearic Islands
Hungary4 sites
Study site
Budapest
Study site
Debrecen
Study site
Miskolc
Study site
Szombathely
Latvia4 sites
Study site
Cekule
Study site
Daugavpils
Study site
Liepāja
Study site
Riga
Poland4 sites
Study site
Bialystok
Study site
Chrzanów
Study site
Warsaw
Study site
Wroclaw
Canada3 sites
Study site
Calgary, Alberta
Study site
Kelowna, British Columbia
Study site
Montreal, Quebec
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 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.
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Being tested
- Ciprofloxacin dispersion for inhalation, Placebo
- Keywords
- Bronchiectasis, non-CF, Ciprofloxacin, Liposome
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin dispersion for inhalationDrug
Also called Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
PlaceboDrug
Also called Liquid formulation of empty liposomes
| 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 exacerbation
Measured: One Year
Secondary outcomes (1)
Number of exacerbations
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study start31 Mar 2014
- Primary completion17 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
- 278 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
- NCT01515007
- Sponsor's protocol ID
- ARD-3150-1201
- Status last verified
- Mar 2021
- First submitted
- 10 Jan 2012
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
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 Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)
- ClinicalTrials.gov ID
- NCT01515007
- Acronym / sponsor ID
- ARD-3150-1201
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Keywords
- Bronchiectasis, non-CF, Ciprofloxacin, Liposome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Aradigm CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Grifols Therapeutics LLC
- Study start
- 31 Mar 2014 (actual)
- Primary completion
- 17 Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Jan 2012 (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-3150-1201, 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 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 (2 listed)
- Verified bronchiectasis diagnosis
- Pseudomonas aeruginosa lung infection
Key exclusion criteria (1 listed)
- Cystic Fibrosis
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 inhalationAlso: Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin | Drug | Ciprofloxacin dispersion for inhalation |
| PlaceboAlso: Liquid formulation of empty liposomes | Drug | Placebo |
Primary outcome
Time to first exacerbation
Time frame: One Year
1 secondary outcome
Number of exacerbations
Time frame: One Year
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.
109 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 109 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 2 inclusion and 1 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 109 sites in United States, United Kingdom, Australia, Germany, Israel 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 exacerbation (time frame: One Year). 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 NCT01515007, 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.