Chronic SinusitisPhase 3NCT00425620
Amphotericin B Suspension in Refractory Chronic Sinusitis
A Phase 3 study testing SinuNase in people with Chronic Sinusitis, run by Accentia Biopharmaceuticals at 68 sites in United States.
Trial summary
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- SinuNase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 68 sitesUnited States
- Study dates
- Dec 2006to Oct 2007
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of refractory, postsurgical chronic sinusitis
- Has a documented history of chronic sinusitis symptoms for more than 12 weeks
- A CT scan showing a certain level of mucosal thickening in at least 1 maxillary sinus
- An endoscopy documenting the presence of inflammation and absence of stage 4 polyps
- Ability to comply with the study requirements including the ability to administer a nasal lavage twice daily for 4 months
- Females of childbearing potential must use adequate birth control methods and not plan to get pregnant during the course of the study.
- Ability to read or speak English
Who cannot join
- Has a hypersensitivity to Amphotericin B or the compounds of any study medications
- Is an immunosuppressed patient or is receiving disease modifying agents
- Has an acute upper or lower respiratory illness
- Has an acute exacerbation of chronic sinusitis within 1 month prior to randomization
- Has used systemic antibiotic therapy for reasons other than acute sinusitis within 3 weeks prior to randomization
- Has used any antibiotic therapy for acute complication of chronic sinusitis within 1 month prior to randomization
Show all 20Show fewer
- Has orbital or central nervous system complications
- Has acute asthma at study initiation
- Began using nasal corticosteroids or had a dosage change within 3 months prior to randomization
- Has taken a dose of oral or intravenous steroids to treat any condition other than asthma within 1 month prior to randomization
- Has used any systemic antifungal therapy within 3 months prior to randomization
- Has used intranasal antifungal therapy for chronic sinusitis within 3 months prior to randomization
- Currently has a clinically significant deviated nasal septum that has not been remedied by surgery
- Has an anatomical abnormality which would significantly obstruct the nasal passages
- Has cystic fibrosis
- Is pregnant
- Has stage 4 polyposis
- Has any significant medical condition that in a doctor's opinion could affect the patient's participation in the trial
- Has used any investigational product within 1 month of study initiation
- Has a history of cancer other than treated squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to study initiation
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
United States68 sites
Allergy Partners of Western North Carolina
Asheville, North Carolina, 28801
Kern Allergy Medical Clinic
Bakersfield, California, 93301
Paul A. Shapero, MD
Bangor, Maine, 04401
Parkway Medical Center
Birmingham, Alabama, 35215
Alabama ENT Associates
Birmingham, Alabama, 35244
Odyssey Research
Bismarck, North Dakota, 58501
Massachusetts General Hospital
Boston, Massachusetts, 02114
Allergy & Asthma Consultants of Montana
Bozeman, Montana, 59718
Connecticut Sinus Center
Bridgeport, Connecticut, 06606
David Sherris, M.D.
Buffalo, New York, 14216
First Allergy & Clinical Research Center
Centennial, Colorado, 80112
Charlotte Eye, Ear, Nose & Throat Associates, P.A.
Charlotte, North Carolina, 28210
The Asthma Institute, PLLC
Chattanooga, Tennessee, 37421
Rush University Medical Center
Chicago, Illinois, 60612
Chest Medicine Consultants
Chicago, Illinois, 60657
Hightop Medical Research Center
Cincinnati, Ohio, 45224
Colorado Otolaryngology Associates, PC
Colorado Springs, Colorado, 80909
Allergy Center at Brookstone
Columbus, Georgia, 31904
Optimed Research
Columbus, Ohio, 43235
Texas Medical and Surgical Associates
Dallas, Texas, 75231
Central Jersey Health Care
Elizabeth, New Jersey, 07202
Center for Specialty Care
Fargo, North Dakota, 58104
Hurley Medical Center
Flint, Michigan, 48503
University Of North Texas Health Science Center
Fort Worth, Texas, 76107-2699
SARC Research Center
Fresno, California, 93720
Allergy & Asthma Care Center
Gainesville, Georgia, 30501
Northeast Georgia Research Center
Gainesville, Georgia, 30501
Clinical Research Advantage
Gilbert, Arizona, 85234
ADAC Research
Greenville, South Carolina, 29607
Allergy & Asthma Associates
Houston, Texas, 77054
Health Sciences Research Center
Ithaca, New York, 14850
Jackson Clinic
Jackson, Tennessee, 38301
Jefferson City Medical Group
Jefferson City, Missouri, 65109
NEA Clinic
Jonesboro, Arkansas, 72401
California Allergy & Asthma Medical Group, Inc.
Los Angeles, California, 90025
Commonwealth ENT, Head and Neck Center
Louisville, Kentucky, 40207
Northwest ENT Associates
Marietta, Georgia, 30060
Monroe Medical Foundation
Monroe, Wisconsin, 53566
Vanderbilt University ASAP Research
Nashville, Tennessee, 37203-1424
Wellington Tichenor, MD
New York, New York, 10021
DiGiovanna Family Care Center
North Massapequa, New York, 11758
COR Clinical Research
Oklahoma City, Oklahoma, 73103
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
Orange, California, 92868
Sterling ENT / Carolina Research
Orangeburg, South Carolina, 29118-4900
Kansas City Allergy & Asthma
Overland Park, Kansas, 66210
Allergy and Asthma Research of NJ, Inc.
Philadelphia, Pennsylvania, 19115
Clinical Research Institute
Plymouth, Minnesota, 55441
Virginia Adult & Pediatric Allergy & Asthma, P.C.
Richmond, Virginia, 23229
Asthma And Allergy Center Of Chicago
River Forest, Illinois, 60305
Integrated Research Group Inc.
Riverside, California, 92506
AAIR Research Center
Rochester, New York, 14618
Allergy Medical Group of the North Area
Roseville, California, 95678
Sacramento ENT
Sacramento, California, 95816
San Antonio Ear, Nose & Throat Research
San Antonio, Texas, 78229
Live Oak Allergy & Asthma Clinic
San Antonio, Texas, 78233
South Bend Clinic
South Bend, Indiana, 46617
St. Louis University
St Louis, Missouri, 63110
Midwest Clinical Research, LLC
St Louis, Missouri, 63141
Bay Front Medical Center
St. Petersburg, Florida, 33701
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Liberty Research Center
Tacoma, Washington, 98405
King's Daughters Clinic
Temple, Texas, 76502
Center for Allergy & Asthma of Bronx & Westchester
The Bronx, New York, 10465
Grand Traverse Allergy
Traverse City, Michigan, 49684
Allergy & Asthma Clinical Research, Inc.
Walnut Creek, California, 94598
Pravin K. Muniyappa, MD, Inc.
West Hills, California, 91307
Institute of Allergy & Asthma
Wheaton, Maryland, 20902
Dr. Ann Bogard Private Practice
Winston-Salem, North Carolina, 27103-4146
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.
- Conditions
- Chronic Sinusitis
- Being tested
- SinuNase
- Keywords
- Chronic Sinusitis, Chronic Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinuNaseDrug
Also called Amphotericin B Suspension
Lavage
| Study group | Role | What they receive |
|---|---|---|
| Amphotericin B | Experimental | Not described Receives: Drug: SinuNase |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startDec 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accentia Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Angelos M Stergiou, MD, Study director, Accentia Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425620
- Sponsor's protocol ID
- ACC-05-01
- Status last verified
- Nov 2007
- First submitted
- 19 Jan 2007
- Last updated
- 30 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)
- ClinicalTrials.gov ID
- NCT00425620
- Acronym / sponsor ID
- ACC-05-01
- Conditions
- Chronic Sinusitis
- Keywords
- Chronic Sinusitis, Chronic Rhinosinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Accentia BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Jan 2007 (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 primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amphotericin B | Experimental | Drug: SinuNase |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a diagnosis of refractory, postsurgical chronic sinusitis
- Has a documented history of chronic sinusitis symptoms for more than 12 weeks
- A CT scan showing a certain level of mucosal thickening in at least 1 maxillary sinus
- An endoscopy documenting the presence of inflammation and absence of stage 4 polyps
- Ability to comply with the study requirements including the ability to administer a nasal lavage twice daily for 4 months
Key exclusion criteria (20 listed)
- Has a hypersensitivity to Amphotericin B or the compounds of any study medications
- Is an immunosuppressed patient or is receiving disease modifying agents
- Has an acute upper or lower respiratory illness
- Has an acute exacerbation of chronic sinusitis within 1 month prior to randomization
- Has used systemic antibiotic therapy for reasons other than acute sinusitis within 3 weeks prior to randomization
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 |
|---|---|---|
| SinuNaseAlso: Amphotericin B SuspensionLavage | Drug | Amphotericin B |
Primary outcome
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.
Time frame: Four months
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 30 Nov 2007.
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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.
Angelos M Stergiou, MD study director
Accentia Biopharmaceuticals
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SinuNase in people with Chronic Sinusitis, run by Accentia Biopharmaceuticals at 68 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 7 inclusion and 20 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 30 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 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 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?
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS. (time frame: Four months). 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 30 Nov 2007.