Trial Outcomes & Findings for Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients (NCT NCT02246920)

Last Updated: 2023-06-08

Results Overview

Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing. The primary analysis for determining the therapeutic equivalence of the Test and Reference treatments will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period. The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence. The Modified Intent to Treat Population (mITT) will be used for Superiority Analysis.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1474 participants

Primary outcome timeframe

2 week treatment period: Day 0-14

Results posted on

2023-06-08

Participant Flow

1474 subjects with SAR were enrolled into placebo run-in for the study.

Subjects were required to enter a 7 day placebo phase prior to randomization. 296 subjects were discovered to be placebo responders and were discontinued from the trial.

Participant milestones

Participant milestones
Measure	Investigational Test Product Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Reference Listed Drug Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Placebo Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Overall Study STARTED	484	460	234
Overall Study COMPLETED	477	453	231
Overall Study NOT COMPLETED	7	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Test Product Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Reference Listed Drug Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Placebo Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Overall Study Adverse Event	3	1	1
Overall Study Lost to Follow-up	2	1	0
Overall Study Protocol Violation	2	5	1
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Test Product n=484 Participants Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Reference Listed Drug n=460 Participants Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Placebo n=234 Participants Saline Placebo Nasal Spray; 4 total sprays/day for 14 days	Total n=1178 Participants Total of all reporting groups
Age, Continuous	39.3 years n=5 Participants	39.4 years n=7 Participants	39.1 years n=5 Participants	39.3 years n=4 Participants
Sex: Female, Male Female	292 Participants n=5 Participants	274 Participants n=7 Participants	154 Participants n=5 Participants	720 Participants n=4 Participants
Sex: Female, Male Male	192 Participants n=5 Participants	186 Participants n=7 Participants	80 Participants n=5 Participants	458 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Black or African American	114 Participants n=5 Participants	108 Participants n=7 Participants	64 Participants n=5 Participants	286 Participants n=4 Participants
Race (NIH/OMB) White	357 Participants n=5 Participants	339 Participants n=7 Participants	160 Participants n=5 Participants	856 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: 2 week treatment period: Day 0-14

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	Investigational Test Product n=479 Participants Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Reference Listed Drug n=458 Participants Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Placebo n=233 Participants Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.	-1.77 score on a scale Standard Error 0.11	-1.57 score on a scale Standard Error 0.10	-1.26 score on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: 2 week treatment period: Day 0 to Day 14

Population: Per Protocol Population

Secondary efficacy analysis will evaluate the mean change from baseline in average iTNSS over the 2 week randomization treatment period. The Per-Protocol Population (PPP) will be used for the analysis of bioequivalence. Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing.

Outcome measures

Outcome measures
Measure	Investigational Test Product n=479 Participants Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Reference Listed Drug n=458 Participants Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Placebo n=233 Participants Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14.	-1.70 score on a scale Standard Error 0.11	-1.53 score on a scale Standard Error 0.11	-1.15 score on a scale Standard Error 0.15

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 week treatment period: Day 0 to Day 14

Population: Modified Intent to Treat

The primary analysis for determining the superiority of each active treatment over placebo will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period. The modified Intent-to-Treat Population (mITT) will be used for the primary analysis of superiority. Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing.

Outcome measures

Outcome measures
Measure	Investigational Test Product n=479 Participants Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Reference Listed Drug n=458 Participants Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Placebo n=233 Participants Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Superiority to Placebo	-1.77 score on a scale Standard Error 0.11	-1.57 score on a scale Standard Error 0.10	-1.26 score on a scale Standard Error 0.15

Adverse Events

Investigational Test Product

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Listed Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Investigational Test Product n=484 participants at risk Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Reference Listed Drug n=460 participants at risk Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days	Placebo n=234 participants at risk Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Injury, poisoning and procedural complications Concussion	0.21% 1/484 • Number of events 1 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.	0.00% 0/460 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.	0.00% 0/234 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.
Injury, poisoning and procedural complications Rib Fracture	0.21% 1/484 • Number of events 1 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.	0.00% 0/460 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.	0.00% 0/234 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.
Psychiatric disorders Conversion disorder	0.21% 1/484 • Number of events 1 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.	0.00% 0/460 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.	0.00% 0/234 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.21% 1/484 • Number of events 1 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.	0.00% 0/460 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.	0.00% 0/234 • Adverse Events were collected from the time of ICF signature through the end of the study. Total duration 4-6 weeks Subjects were queried on health status and any changes at each visit.

Other adverse events

Adverse event data not reported

Additional Information

Director, PD/CE Studies

Teva Pharmaceuticals USA

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI may not publish the results of this generic (ANDA) trial without sponsor review and approval.
Publication restrictions are in place

Restriction type: OTHER