SinusitisPhase 2NCT00232154
A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To
A Phase 2 study testing Zithromax™ (azithromycin) 500mg tablets, Endoscopic Sinus Surgery and Blood sampling for hematology in people with Sinusitis, run by Pfizer at 18 sites in United States.
Trial summary
To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets for up to 3 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Zithromax™ (azithromycin) 500mg tablets, Endoscopic Sinus Surgery and Blood sampling for hematology
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 72 participants
- Where
- 18 sitesUnited States
- Study dates
- Nov 2005to Jun 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects considered by the Principal Investigator as an appropriate candidate for endoscopic sinus surgery, e.g., for the removal of the thickened and diseased mucosal tissue that blocks the ostiomeatal complex (OMC).
Who cannot join
- Known or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, azithromycin or telithromycin.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Pfizer Investigational Site
Alabaster, Alabama, 35007
Pfizer Investigational Site
Augusta, Georgia, 30912
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35242
Pfizer Investigational Site
Carrollton, Kentucky, 41008
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Elgin, Illinois, 60120
Pfizer Investigational Site
Elgin, Illinois, 60123
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Hoover, Alabama, 35216
Pfizer Investigational Site
Hoover, Alabama, 35244
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
La Grange, Kentucky, 40031
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Miami, Florida, 33136-1002
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Open-Label Study Of Azithromycin Pharmacokinetics In Sinus Mucosal Tissue And Plasma In Subjects With Chronic Rhinosinusitis Following A Single 2g Dose Of Azithromycin Extended Release For Oral Suspension Or Azithromycin 500mg Tablet Formulation Once Daily For A Maximum Of Three Days
To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets for up to 3 days.
- Conditions
- Sinusitis
- Being tested
- Zithromax™ (azithromycin) 500mg tablets, Endoscopic Sinus Surgery, Blood sampling for hematology, Blood sampling for plasma chemistry profile, Serum pregnancy test (for women of child-bearing potential)
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zithromax™ (azithromycin) 500mg tabletsDrug
Endoscopic Sinus SurgeryProcedure or surgery
Blood sampling for hematologyProcedure or surgery
Blood sampling for plasma chemistry profileProcedure or surgery
Serum pregnancy test (for women of child-bearing potential)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet
Secondary outcomes (1)
To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232154
- Sponsor's protocol ID
- A0661151
- Status last verified
- Apr 2011
- First submitted
- 30 Sep 2005
- Last updated
- 21 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Of Azithromycin Pharmacokinetics In Sinus Mucosal Tissue And Plasma In Subjects With Chronic Rhinosinusitis Following A Single 2g Dose Of Azithromycin Extended Release For Oral Suspension Or Azithromycin 500mg Tablet Formulation Once Daily For A Maximum Of Three Days
- ClinicalTrials.gov ID
- NCT00232154
- Acronym / sponsor ID
- A0661151
- Conditions
- Sinusitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 4 Oct 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.
To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets for up to 3 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects considered by the Principal Investigator as an appropriate candidate for endoscopic sinus surgery, e.g., for the removal of the thickened and diseased mucosal tissue that blocks the ostiomeatal complex (OMC).
Key exclusion criteria (1 listed)
- Known or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, azithromycin or telithromycin.
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 |
|---|---|---|
| Zithromax™ (azithromycin) 500mg tablets | Drug | – |
| Endoscopic Sinus Surgery | Procedure or surgery | – |
| Blood sampling for hematology | Procedure or surgery | – |
| Blood sampling for plasma chemistry profile | Procedure or surgery | – |
| Serum pregnancy test (for women of child-bearing potential) | Procedure or surgery | – |
Primary outcome
To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet
1 secondary outcome
To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.
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 21 Apr 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Sinusitis
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Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
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ACUTE SINUSITIS, Sinusitis
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.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zithromax™ (azithromycin) 500mg tablets, Endoscopic Sinus Surgery and Blood sampling for hematology in people with Sinusitis, run by Pfizer at 18 sites 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 1 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 21 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet. 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 21 Apr 2011.