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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03591068
Other study ID # OPN-FLU-NP-3104
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 7, 2018
Est. completion date February 22, 2019

Study information

Verified date July 2020
Source Optinose US Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.


Description:

The primary objective of this study is to evaluate the efficacy and safety of OPN-375 186 μg twice a day in adults with Bilateral Nasal Polyps using Nasoendoscopic video. The secondary objectives of this study are to evaluate the safety of OPN-375 via adverse event reports, vital signs, and nasal examination. In addition, to measure any change in subject symptoms and functioning from Baseline to 12 and 24 weeks during the study, using the Sinonasal Outcome Test -22 (SNOT-22), Patient's Global Impression of Change (PGIC), and measurement of nasal polyps by independent, blinded reader, and any changes throughout the study.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fluticasone Propionate
OPN-375 186 µg BID, Delivered via exhalation delivery system

Locations

Country Name City State
United States University of Colorado SOM, Department of Otolaryngology Aurora Colorado
United States University of Texas Health Science Center at Houston, McGovern Medical School, Dept. of Otolaryngology, Head and Neck Surgery Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Optinose US Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video : Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Week 24
Secondary Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests 24 Weeks, up to 30 days after last dose
Secondary Assessment for Safety Through Nasal Examination Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum. If present, the nostril location is also recorded, along with severity, and if there is any relation to an injury or trauma 24 Weeks, up to 30 days after last dose
Secondary Assessment for Safety From Recording Vital Sign - Blood Pressure Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg) Baseline, Week 12, Week 24
Secondary Assessment for Safety From Recording Vital Sign - Pulse measure pulse in beats per minute (bpm) Baseline, Week 12, Week 24
Secondary Assessment for Safety From the Collection of Information for Concomitant Medications Usage 24 Weeks, up to 30 days after last dose
Secondary Total Polyp Grading Score (Sum of Scores From Both Nasal Cavities) Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Week 24
Secondary Number of Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Week 24
Secondary Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Week 24
Secondary Sinonasal Outcome Test 22 (SNOT-22) Total Score SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. The total score can range from 0-110, 0 being the best and 110 being the worst.
0: No problem
Very mild problem
Mild or slight problem
Moderate problem
Severe problem
Problem as bad as can be
Week 24
Secondary Sniffin' Sticks N-butanol Test The Sniffin' Sticks n-butanol (Extended test) are used to investigate human olfactory performance by use of odor pens. the Extended Test consists of 3 different subtests: Threshold, Discrimination and Identification. the Threshold test is used to ascertain the patient's olfactory threshold. the Discrimination test requires the patient to differentiate smells. The Identification test requires the patient to identify everyday smells by means of a card with different choices. The result of this test is expressed as the sum of the results of the 3 subtests, the so called TDI score (threshold, discrimination, identification). A score of more than 30 rates as normal, a score of 30 or less indicates hyposmia and a score of 15 and below point to functional anosmia in form of complete loss of the sense of smell or an extremely weakened smell ability. Week 24
Secondary Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved The Patient Global Impression of Change (PGIC), is a questionnaire where the patient rates the change in their symptoms. Score range is from 1 (very much improved) to 7 (very much worse) Week 24
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