Trial Outcomes & Findings for 3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis (NCT NCT01794741)

NCT ID: NCT01794741

Last Updated: 2015-03-31

Results Overview

reports of treatment emergent adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 405 participants
• Primary outcome timeframe: 3 months of treatment
• Results posted on: 2015-03-31

Participant Flow

Participant milestones

Measure	Dymista Nasal Spray azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months Dymista Nasal Spray	Fluticasone Propionate Nasal Spray fluticasone propionate nasal spray 50mcg per spray per nostril twice a day Fluticasone propionate nasal spray
Overall Study STARTED	304	101
Overall Study COMPLETED	285	92
Overall Study NOT COMPLETED	19	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis

Baseline characteristics by cohort

Measure	Dymista Nasal Spray n=304 Participants azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months Dymista Nasal Spray	Fluticasone Propionate Nasal Spray n=101 Participants fluticasone propionate nasal spray 50mcg per spray per nostril twice a day Fluticasone propionate nasal spray	Total n=405 Participants Total of all reporting groups
Age, Categorical <=18 years	304 Participants n=5 Participants	101 Participants n=7 Participants	405 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	8.1 years STANDARD_DEVIATION 2.07 • n=5 Participants	8.1 years STANDARD_DEVIATION 1.94 • n=7 Participants	8.1 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants	49 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Male	183 Participants n=5 Participants	52 Participants n=7 Participants	235 Participants n=5 Participants
Region of Enrollment United States	304 participants n=5 Participants	101 participants n=7 Participants	405 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months of treatment

reports of treatment emergent adverse events

Outcome measures

Measure	Dymista Nasal Spray n=302 Participants	Fluticasone Nasal Spray n=98 Participants
Adverse Events Report	124 event	37 event

Adverse Events

Dymista Nasal Spray

Serious events: 1 serious events

Other events: 114 other events

Deaths: 0 deaths

Fluticasone Propionate Nasal Spray

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dymista Nasal Spray n=304 participants at risk azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months Dymista Nasal Spray	Fluticasone Propionate Nasal Spray n=101 participants at risk fluticasone propionate nasal spray 50mcg per spray per nostril twice a day Fluticasone propionate nasal spray
Gastrointestinal disorders gastroenteritis elevated LFT	0.33% 1/304 • Number of events 1	0.00% 0/101

Other adverse events

Measure	Dymista Nasal Spray n=304 participants at risk azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months Dymista Nasal Spray	Fluticasone Propionate Nasal Spray n=101 participants at risk fluticasone propionate nasal spray 50mcg per spray per nostril twice a day Fluticasone propionate nasal spray
Respiratory, thoracic and mediastinal disorders epistaxis	9.9% 30/304	8.9% 9/101
General disorders headache	6.6% 20/304	3.0% 3/101
Respiratory, thoracic and mediastinal disorders cough	3.6% 11/304	3.0% 3/101
General disorders pyrexia	3.3% 10/304	2.0% 2/101
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	3.0% 9/304	0.00% 0/101
Ear and labyrinth disorders otitis media	3.0% 9/304	3.0% 3/101
Gastrointestinal disorders vomiting	3.0% 9/304	2.0% 2/101
Gastrointestinal disorders abdominal pain upper	2.6% 8/304	2.0% 2/101
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	2.6% 8/304	0.99% 1/101

Additional Information

Dr Nancy Ruiz, MD

Meda Pharmaceuticals

Phone: 732 564 2390

Email: nancy.ruiz@meda.us

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