Trial Outcomes & Findings for Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR) (NCT NCT01915823)

Results Overview

change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

348 participants

Primary outcome timeframe

15 days of treatment

Results posted on

2015-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily azelastine hydrochloride and fluticasone propionate	Dymista Vehicle Dose: vehicle only Regimen: 1 spray per nostril twice daily Dymista vehicle
Overall Study STARTED	173	175
Overall Study COMPLETED	171	173
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dymista n=173 Participants (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily azelastine hydrochloride and fluticasone propionate	Dymista Vehicle n=175 Participants Dose: vehicle only Regimen: 1 spray per nostril twice daily Dymista vehicle	Total n=348 Participants Total of all reporting groups
Age, Categorical <=18 years	173 Participants n=5 Participants	175 Participants n=7 Participants	348 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	8.5 years STANDARD_DEVIATION 2.11 • n=5 Participants	8.4 years STANDARD_DEVIATION 2.06 • n=7 Participants	8.4 years STANDARD_DEVIATION 2.08 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	85 Participants n=7 Participants	162 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	90 Participants n=7 Participants	186 Participants n=5 Participants
Region of Enrollment United States	173 participants n=5 Participants	175 participants n=7 Participants	348 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 days of treatment

change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.

Outcome measures

Outcome measures
Measure	Dymista n=152 Participants (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily azelastine hydrochloride and fluticasone propionate	Dymista Vehicle n=152 Participants Dose: vehicle only Regimen: 1 spray per nostril twice daily Dymista vehicle
Primary Efficacy	-3.83 units on a scale Standard Deviation 5.154	-2.77 units on a scale Standard Deviation 4.731

SECONDARY outcome

Timeframe: entire length of study (day 1 to day 22)

* Subject-reported adverse experiences (incidence, type, and severity of adverse events) * Nasal Examinations * Vital signs assessments

Outcome measures

Outcome measures
Measure	Dymista n=173 Participants (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily azelastine hydrochloride and fluticasone propionate	Dymista Vehicle n=175 Participants Dose: vehicle only Regimen: 1 spray per nostril twice daily Dymista vehicle
Safety	28 occurance	23 occurance

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1 to day 15 of treatment

Change from baseline to Visit 4 in the ITT ( intent to treat) Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) in subjects equal to or greater than 6 years old and less than12 years old compared to placebo.Scored on a 0 to 7 scale with 0 being not troubled at all and 7 being extremely troublesome. The higher the difference the better the result.

Outcome measures

Outcome measures
Measure	Dymista n=126 Participants (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily azelastine hydrochloride and fluticasone propionate	Dymista Vehicle n=135 Participants Dose: vehicle only Regimen: 1 spray per nostril twice daily Dymista vehicle
Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)	-.91 units on a scale Standard Deviation 1.22	-.66 units on a scale Standard Deviation 1.22

Adverse Events

Dymista

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Dymista Vehicle

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dymista n=173 participants at risk (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily azelastine hydrochloride and fluticasone propionate	Dymista Vehicle n=175 participants at risk Dose: vehicle only Regimen: 1 spray per nostril twice daily Dymista vehicle
Nervous system disorders dysgusia	4.0% 7/173	0.00% 0/175
Respiratory, thoracic and mediastinal disorders epistaxis	3.5% 6/173	3.4% 6/175

Additional Information

Dr.Nancy Ruiz,MD

Meda Pharmaceuticals

Phone: 7325642390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Meda Pharmaceuticals requests that it receive copies of any intended communication at least 15 working days for an abstract or oral presentation and 45 working days for a manuscript). This is to allow Meda Pharmaceuticals to review the communications for accuracy , to verify that confidential information is not being inadvertently divulged, to provide any relevant supplementary information, and to allow establishment of co-authorship.
Publication restrictions are in place

Restriction type: OTHER