Non-Cystic Fibrosis BronchiectasisPhase 2NCT00889967
Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
A Phase 2 study testing Ciprofloxacin for Inhalation in people with Non-Cystic Fibrosis Bronchiectasis, run by Aradigm Corporation at 37 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Cystic Fibrosis Bronchiectasis
- What is being tested?
- Ciprofloxacin for Inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 37 sitesin 4 countries
- Study dates
- Feb 2010to Jun 2011
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are willing and able to provide written informed consent.
- Are males or females 18 to 80 year of age, inclusive.
- Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
- Confirmation of infection with P. aeruginosa at screening
Who cannot join
- Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.
- Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
- Have a diagnosis of cystic fibrosis..
- Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:
- Azithromycin
- Hypertonic saline
Show all 10Show fewer
- Bronchodilator medications
- Oral corticosteroid.
- Have received an investigational drug or device within 28 days prior to Visit 1.
- Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol.
Trial locations and contacts
37 sites in 4 countries.
37 sites in 4 countries
United States14 sites
Study site
Brandon, Florida, 33511
Study site
Council Bluffs, Iowa, 51503
Study site
Elizabeth City, North Carolina, 27909
Study site
Los Angeles, California, 90048
Study site
McKinney, Texas, 75069
Study site
Miami, Florida, 33136
Study site
New York, New York, 10016
Study site
Philadelphia, Pennsylvania, 19104
Study site
Phoenix, Arizona, 85006
Study site
Sacramento, California, 95819
Study site
Summit, New Jersey, 07901
Study site
Toledo, Ohio, 43614
Study site
Torrance, California, 90505
Study site
Waterbury, Connecticut, 06708
United Kingdom12 sites
"Ground Floor, Tower Block, Lisburn Road
Belfast, Britain, BT9 7AB
"1st Floor, Nuffield House, B15 2TH
Birmingham, Britain
"Bordesley Green East
Birmingham, B9 5SS
"Duckworth Lane,
Bradford, Britain, BD9 6RJ
"133 Balornock Road
Glasgow, G21 3UW
Study site
London, High Street Lewisham, SE13 6LH
Royal Brompton Hospital
London, SW3 6NP
"Southmoor Road, M23 9LT
Manchester, Britain
Study site
Newcastle upon Tyne, Freeman Road, High Heaton, NE7 7DN
"Stott Lane
Salford, M6 8HD
"Newcastle Road
Stoke-on-Trent, ST4 6QG
"Northumbria Healthcare
Tyne and Wear, NE29 8NH
Canada7 sites
Study site
Calgary, Alberta, T2N 1L9
Study site
Kelowna, British Columbia, V1Y 1E4
Study site
Montreal, Quebec, H2W 1T8
Study site
Ottawa, Ontario, K1Y 4E9
Study site
Saint-Jérôme, Quebec, J7Z 5T3
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Vancouver, British Columbia, V5Z 4E1
Germany4 sites
Study site
Berlin, 13353
Study site
Donaustauf, 93093
Study site
Heidelberg, 69126
Study site
Neuwied, 56564
About this study
Official title: An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis
The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Being tested
- Ciprofloxacin for Inhalation, Placebo
- Keywords
- Pseudomonas aeruginosa, antimicrobial, inhalation, ciprofloxacin, Non-Cystic Fibrosis Bronchiectasis
- Medical subject headings
- Pseudomonas Infections, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin for InhalationDrug
100 mg once daily by inhalation for 28 days
Ciprofloxacin for InhalationDrug
150 mg once daily by inhalation for 28 days
PlaceboDrug
Placebo once daily by inhalation for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ciprofloxacin for Inhalation 100 mg/day by inhalation Receives: Drug: Ciprofloxacin for Inhalation |
| 2 | Experimental | Ciprofloxacin for inhalation 150 mg/day by inhalation Receives: Drug: Ciprofloxacin for Inhalation |
| Placebo | Placebo comparator | Placebo by inhalation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28.
Measured: 28 days
Secondary outcomes (5)
Microbiological efficacy
Measured: 28 days
Time to, number of, severity of, and time to resolve exacerbations
Measured: 28 days
Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability
Measured: 28 days
Quality of life (QOL)
Measured: 28 days
Safety and tolerability
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startFeb 2010
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aradigm Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Bruinenberg, MBChB, MBA, Study director, Aradigm Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889967
- Sponsor's protocol ID
- ARD-3100-0901
- Status last verified
- Aug 2012
- First submitted
- 27 Apr 2009
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT00889967
- Acronym / sponsor ID
- ARD-3100-0901
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Keywords
- Pseudomonas aeruginosa, antimicrobial, inhalation, ciprofloxacin, Non-Cystic Fibrosis Bronchiectasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Aradigm CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 29 Apr 2009 (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.
The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ciprofloxacin for InhalationCiprofloxacin for Inhalation 100 mg/day by inhalation |
| 2 | Experimental | Drug: Ciprofloxacin for InhalationCiprofloxacin for inhalation 150 mg/day by inhalation |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo by inhalation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are willing and able to provide written informed consent.
- Are males or females 18 to 80 year of age, inclusive.
- Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
- Confirmation of infection with P. aeruginosa at screening
Key exclusion criteria (10 listed)
- Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.
- Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
- Have a diagnosis of cystic fibrosis..
- Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:
- Have received an investigational drug or device within 28 days prior to Visit 1.
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 for Inhalation100 mg once daily by inhalation for 28 days | Drug | 1 |
| Ciprofloxacin for Inhalation150 mg once daily by inhalation for 28 days | Drug | 2 |
| PlaceboPlacebo once daily by inhalation for 28 days | Drug | Placebo |
Primary outcome
The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28.
Time frame: 28 days
5 secondary outcomes
Microbiological efficacy
Time frame: 28 days
Time to, number of, severity of, and time to resolve exacerbations
Time frame: 28 days
Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability
Time frame: 28 days
Quality of life (QOL)
Time frame: 28 days
Safety and tolerability
Time frame: 28 days
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 25 Jan 2017.
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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.
Paul Bruinenberg, MBChB, MBA study director
Aradigm Corporation
37 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciprofloxacin for Inhalation in people with Non-Cystic Fibrosis Bronchiectasis, run by Aradigm Corporation at 37 sites in 4 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 4 inclusion and 10 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, United Kingdom, Canada, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2017.