- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01623323
Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
A 3-Month Open-Label Multicenter Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85032
- Precision Trials
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Colorado
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Colorado Springs, Colorado, United States, 80909
- Colorado ENT and Allergy
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Florida
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Largo, Florida, United States, 33778
- Sher Allergy
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Georgia
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Decatur, Georgia, United States, 30030
- ENT of Georgia
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Louisiana
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New Orleans, Louisiana, United States, 70115
- Best Clinical Trials
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Maryland
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Wheaton, Maryland, United States, 20902
- Institute for Asthma and Allergy
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Montana
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Bozeman, Montana, United States, 59718
- Clinical Research Group of Montana
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New York
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New Windsor, New York, United States, 12553
- ENT and Allergy Associates
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West Nyack, New York, United States, 10994
- ENT and Allergy Associates
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Vital Prospects Clinical Research Institute
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Oregon
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Portland, Oregon, United States, 97202
- Allergy Associates Research Center
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Texas
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Live Oak, Texas, United States, 78233
- Live Oak Allergy and Asthma Clinic
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San Antonio, Texas, United States, 78256
- Texas Quest Medical Research
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Utah
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Draper, Utah, United States, 84020
- Focus Clinical Research
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Salt Lake City, Utah, United States, 84102
- InterMountain Ear Nose and Throat
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St George, Utah, United States, 84790
- Chrysalis Clinical Research
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West Jordan, Utah, United States, 84088
- Advanced Clinical Research
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Washington
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Spokane, Washington, United States, 99204
- Premier Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men or women aged 18 years and older
Women must
- be practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [eg, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], or male partner sterilization) before entry and throughout the study, or
- be surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation at least 1 year before screening) or otherwise be incapable of pregnancy, or
- be postmenopausal (spontaneous amenorrhea for at least 1 year).
- Women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at the screening visit
- Have either:
a history of chronic sinusitis with bilateral nasal polyposis determined by nasoendoscopy at screening visit OR a history of chronic sinusitis (without polyps) for equal to or greater than 12 weeks and currently experiencing 2 or more of the following symptoms, one of which MUST be either nasal blockage/congestion or nasal discharge (anterior and/or posterior nasal discharge):
- nasal blockage/congestion
- nasal discharge (anterior and/or posterior nasal discharge)
- facial pain or pressure
reduction or loss of smell
- Subjects with comorbid asthma or COPD must be stable with no exacerbations (eg, no emergency room visits, hospitalizations, or oral or parenteral steroid use) within the 3 months before the screening visit. Inhaled corticosteroid use must be limited to stable doses of no more than 1,000 μg/day of beclomethasone (or equivalent; See Attachment 1) for at least 3 months before screening with plans to continue use throughout the study.
- Must be able to cease treatment with intranasal steroids and inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at the screening visit
- Must be able to use the OptiNose device correctly; all subjects will be required to demonstrate correct use of the placebo device at the screening visit, see Section 12.1, Visit 1, screening procedures.
- Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Subjects must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Women who are pregnant or lactating
- Inability to have each nasal cavity examined for any reason, including nasal septum deviation
- Nasal septum perforation
- Has had more than 1 episode of epistaxis with frank bleeding in the month before the screening visit
- Have evidence of significant baseline mucosal injury, ulceration or erosion (eg, exposed cartilage, perforation) on baseline nasal examination/nasoendoscopy
- History of sinus or nasal surgery within 6 months before the screening visit
- Current, ongoing rhinitis medicamentosa (rebound rhinitis)
- Have significant oral structural abnormalities, eg, a cleft palate
- Diagnosis of cystic fibrosis
- History of Churg-Strauss syndrome or dyskinetic ciliary syndromes
- Purulent nasal infection, acute sinusitis, or upper respiratory tract infection within 2 weeks before the screening visit. Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution
- Planned sinonasal surgery during the period of the study
- Allergy, hypersensitivity, or contraindication to corticosteroids or steroids
- Allergy or hypersensitivity to any excipients in study drug
- Exposure to any glucocorticoid treatment with potential for systemic effects (eg, oral, parenteral, intra-articular, or epidural steroids, high dose topical steroids) within 1 month before the screening visit; except as noted in inclusion criteria for subjects with comorbid asthma or COPD
- Have nasal candidiasis
- Have taken a potent CYP3A4 inhibitor within 14 days before the screening visit; examples of these medications can be found in Section 11.6, Concomitant Medication.
- History or current diagnosis of any form of glaucoma or ocular hypertension (ie, intraocular pressure >21 mmHg)
- History of intraocular pressure elevation on any form of steroid therapy
- History or current diagnosis of the presence (in either eye) of a cataract
- Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study
- A recent (within 1 year of the screening visit) clinically significant history of drug or alcohol use, abuse, or dependence that, in the opinion of the investigator could interfere with the subject's participation or compliance in the study
- Positive urine drug screen at screening visit for drugs of abuse (see Section 14.5), with the exception of prescribed medications for legitimate medical conditions
- Have participated in a previous clinical trial of OPTINOSE FLUTICASONE
- Have participated in an investigational drug clinical trial within 30 days of the screening visit
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Fluticasone
|
Fluticasone Propionate 400 μg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Baseline to 3 months or End of Study
|
Adverse Events were collected via spontaneous subject report and through physician examination.
The display of adverse events is by subject.
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Baseline to 3 months or End of Study
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Disease Attributes
- Otorhinolaryngologic Diseases
- Pathological Conditions, Anatomical
- Paranasal Sinus Diseases
- Nose Diseases
- Sinusitis
- Chronic Disease
- Nasal Polyps
- Polyps
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
- Xhance
Other Study ID Numbers
- OPN-FLU-CS-3204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Sinusitis With or Without Nasal Polyps
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Ohio State UniversityActive, not recruitingChronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsUnited States
-
GB001, Inc, a wholly owned subsidiary of Gossamer...CompletedChronic Rhinosinusitis Without Nasal Polyps (CRSsNP) | Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)United States, Czechia, Ukraine
-
St. Paul's Sinus CentreRecruitingAsthma | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsCanada
-
Christiane HaaseActive, not recruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsDenmark
-
PfizerBiohaven Pharmaceutical Holding Company Ltd.Active, not recruitingChronic Rhinosinusitis (CRS) With and Without Nasal PolypsUnited States
-
SanofiRegeneron PharmaceuticalsCompletedChronic Sinusitis | Sinusitis | Chronic Rhinosinusitis Without Nasal Polyps | Sinus Disorder | Respiratory DisorderBelgium, Spain, Argentina, Ukraine, Portugal, China, United States, Canada, Chile, Hungary, Korea, Republic of, Russian Federation, Sweden
-
St. Paul's Hospital, CanadaUnknownChronic Rhinosinusitis With Nasal Polyps | Allergic Fungal Sinusitis
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Loma Linda UniversityWithdrawnChronic Rhinosinusitis Without Nasal Polyps (CRSsNP)United States
-
Northwestern UniversityTerminatedChronic Rhinosinusitis Without Nasal PolypsUnited States
-
Insmed IncorporatedRecruitingChronic Rhinosinusitis Without Nasal PolypsUnited States, Australia, Argentina, Canada
Clinical Trials on Fluticasone Propionate
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University of FloridaFood and Drug Administration (FDA)Completed
-
GlaxoSmithKlineCompleted
-
Teva Pharmaceuticals USATerminatedSeasonal Allergic RhinitisUnited States
-
PfizerCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedAsthmaUnited States, Argentina, Philippines, Canada, Brazil
-
Padagis LLCCompleted
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
Boehringer IngelheimCompletedAsthmaUnited States, Australia, Canada, Colombia, Korea, Republic of, Mexico, New Zealand, Peru, Philippines, Taiwan