Trial Outcomes & Findings for 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 (NCT NCT01623323)

NCT ID: NCT01623323

Last Updated: 2016-08-29

Results Overview

Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 705 participants
• Primary outcome timeframe: Baseline to 3 months or End of Study
• Results posted on: 2016-08-29

Participant Flow

Participant milestones

Measure	OPN-375 OPN-375 400 mcg/twice daily
Overall Study STARTED	705
Overall Study COMPLETED	601
Overall Study NOT COMPLETED	104

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	OPN-375 n=705 Participants OPN-375 400 mcg/twice daily
Age, Continuous	45.3 years STANDARD_DEVIATION 13.71 • n=5 Participants
Sex: Female, Male Female	403 Participants n=5 Participants
Sex: Female, Male Male	302 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	624 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	114 Participants n=5 Participants
Race (NIH/OMB) White	552 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	705 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months or End of Study

Population: All subject who received at least one dose of study medication

Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.

Outcome measures

Measure	OPN-375 n=705 Participants OPN-375 400 mcg/twice daily
Adverse Events	270 participants

Adverse Events

OPN-375

Serious events: 5 serious events

Other events: 180 other events

Deaths: 0 deaths

Serious adverse events

Measure	OPN-375 n=705 participants at risk OPN-375 400 mcg/twice daily
Hepatobiliary disorders acute cholecystitis	0.14% 1/705 • Number of events 1 • 3 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma	0.14% 1/705 • Number of events 1 • 3 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.14% 1/705 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.14% 1/705 • Number of events 1 • 3 months
Vascular disorders Hypotension	0.14% 1/705 • Number of events 1 • 3 months

Other adverse events

Measure	OPN-375 n=705 participants at risk OPN-375 400 mcg/twice daily
Respiratory, thoracic and mediastinal disorders epistaxis	14.5% 102/705 • 3 months
Respiratory, thoracic and mediastinal disorders Nasal Mucosal Disorder	10.2% 72/705 • 3 months
Respiratory, thoracic and mediastinal disorders Nasal Septal Disorder	5.5% 39/705 • 3 months

Additional Information

Jennifer Carothers

OptiNose

Phone: 908-432-3061

Email: jennifer.carothers@optinose.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60