Trial Outcomes & Findings for Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis (NCT NCT02230696)

Last Updated: 2021-10-22

Results Overview

The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

951 participants

Primary outcome timeframe

Day 1 through Day 14

Results posted on

2021-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Test Product Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo	Reference Product Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray Meda	Placebo Product Placebo nasal spray
Overall Study STARTED	381	376	194
Overall Study COMPLETED	366	365	190
Overall Study NOT COMPLETED	15	11	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Product n=381 Participants Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate	Reference Product n=376 Participants Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate	Placebo Product n=194 Participants Placebo nasal spray Placebo nasal spray	Total n=951 Participants Total of all reporting groups
Age, Continuous	37.5 years STANDARD_DEVIATION 12.87 • n=5 Participants	38.6 years STANDARD_DEVIATION 13.28 • n=7 Participants	38.4 years STANDARD_DEVIATION 13.07 • n=5 Participants	38.1 years STANDARD_DEVIATION 13.07 • n=4 Participants
Sex: Female, Male Female	250 Participants n=5 Participants	248 Participants n=7 Participants	123 Participants n=5 Participants	621 Participants n=4 Participants
Sex: Female, Male Male	131 Participants n=5 Participants	128 Participants n=7 Participants	71 Participants n=5 Participants	330 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	52 Participants n=5 Participants	59 Participants n=7 Participants	30 Participants n=5 Participants	141 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	329 Participants n=5 Participants	316 Participants n=7 Participants	164 Participants n=5 Participants	809 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	85 Participants n=5 Participants	81 Participants n=7 Participants	41 Participants n=5 Participants	207 Participants n=4 Participants
Race (NIH/OMB) White	283 Participants n=5 Participants	285 Participants n=7 Participants	148 Participants n=5 Participants	716 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 14

Population: Per protocol population

Outcome measures

Outcome measures
Measure	Test Product n=349 Participants Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo	Reference Product n=349 Participants Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda	Placebo Nasal Spray n=181 Participants Placebo nasal spray
Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS)	-2.95 score on a scale Standard Error .15	-3.13 score on a scale Standard Error .15	-1.98 score on a scale Standard Error .19

SECONDARY outcome

Timeframe: Day 1 through Day 14

Population: per-protocol population

The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.

Outcome measures

Outcome measures
Measure	Test Product n=349 Participants Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo	Reference Product n=349 Participants Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda	Placebo Nasal Spray n=181 Participants Placebo nasal spray
Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)	-2.81 score on a scale Standard Error 0.15	-2.96 score on a scale Standard Error 0.15	-1.88 score on a scale Standard Error .19

SECONDARY outcome

Timeframe: Day 1, up to four hours post the first dose

This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation. Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.

Outcome measures

Outcome measures
Measure	Test Product n=343 Participants Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo	Reference Product n=343 Participants Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda	Placebo Nasal Spray n=181 Participants Placebo nasal spray
Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose	-3.41 units on a scale Standard Error 0.15	-3.29 units on a scale Standard Error 0.15	-2.94 units on a scale Standard Error .20

Adverse Events

Test Product

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Product

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Product n=381 participants at risk Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate	Reference Product n=376 participants at risk Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate	Placebo Product n=194 participants at risk Placebo nasal spray Placebo nasal spray
Pregnancy, puerperium and perinatal conditions Fetal demise	0.00% 0/381 • 14 days	0.27% 1/376 • Number of events 1 • 14 days	0.00% 0/194 • 14 days
Musculoskeletal and connective tissue disorders cervical disc herniation	0.26% 1/381 • Number of events 1 • 14 days	0.00% 0/376 • 14 days	0.00% 0/194 • 14 days
Infections and infestations Infected cat bite	0.26% 1/381 • Number of events 1 • 14 days	0.00% 0/376 • 14 days	0.00% 0/194 • 14 days
Psychiatric disorders suicidal ideations	0.26% 1/381 • Number of events 1 • 14 days	0.00% 0/376 • 14 days	0.00% 0/194 • 14 days

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Schwartz

Perrigo

Phone: 718-960-9900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER