Cystic FibrosisPhase 2NCT00205634
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
A Phase 2 study testing Biaxin ( clarithromycin) in people with Cystic Fibrosis, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 6 to 50 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Biaxin ( clarithromycin)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Oct 2004
- 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 6 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of CF
- ability to reliably perform spirometry
- FEV1 of 30% predicted at the time of screening
Who cannot join
- Mycobacterium in a sputum culture ever recorded
- a respiratory exacerbation requiring IV antibiotics in the 60 days prior
- used a investigational drug or device in the 60 days prior
- significant (>30ml) of hemoptysis in the past year
- require oxygen or have significant liver or renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have CF, and is sometimes used in CF patients as well. Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some preliminary studies that have been done in CF patients suggest that Biaxin might have a beneficial effect on CF sputum in ways unrelated to its antibiotic activity.
- Conditions
- Cystic Fibrosis
- Being tested
- Biaxin ( clarithromycin)
- Keywords
- Cystic Fibrosis (CF), Macrolide antiobiotics, airway inflammation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biaxin ( clarithromycin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Testing - FEV1
Quality of Life
Secondary outcomes (2)
decrease in neutrophil-dominated airway inflammation
decrease in Pseudomonas alginate production in vitro and in the airway
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2000
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Bruce K Rubin, MEngr,MD,MBA, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205634
- Sponsor's protocol ID
- BG99-486
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2005
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00205634
- Acronym / sponsor ID
- BG99-486
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis (CF), Macrolide antiobiotics, airway inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Dec 2000 (actual)
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 20 Sep 2005 (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 whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have CF, and is sometimes used in CF patients as well. Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some preliminary studies that have been done in CF patients suggest that Biaxin might have a beneficial effect on CF sputum in ways unrelated to its antibiotic activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosis of CF
- ability to reliably perform spirometry
- FEV1 of 30% predicted at the time of screening
Key exclusion criteria (5 listed)
- Mycobacterium in a sputum culture ever recorded
- a respiratory exacerbation requiring IV antibiotics in the 60 days prior
- used a investigational drug or device in the 60 days prior
- significant (>30ml) of hemoptysis in the past year
- require oxygen or have significant liver or renal disease
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 |
|---|---|---|
| Biaxin ( clarithromycin) | Drug | – |
Primary outcome
Pulmonary Function Testing - FEV1
Quality of Life
2 secondary outcomes
decrease in neutrophil-dominated airway inflammation
decrease in Pseudomonas alginate production in vitro and in the airway
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 13 Aug 2018.
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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.
Bruce K Rubin, MEngr,MD,MBA principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biaxin ( clarithromycin) in people with Cystic Fibrosis, run by Wake Forest University at 1 site in United States.
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 5 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Pulmonary Function Testing - FEV1. The study lists 2 primary outcomes in all. 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 13 Aug 2018.