Trial · NCT01794741

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

NCT01794741, Phase 3, Completed, Meda Pharmaceuticals; results first posted 2015-03-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis. Trials, record NCT01794741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01794741

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis
NCT number: NCT01794741
Status: Completed
Phases: Phase 3
Enrollment: 405 participants, actual
Lead sponsor: Meda Pharmaceuticals
Conditions: Allergic Rhinitis
Interventions: Dymista Nasal Spray, Fluticasone propionate nasal spray
First posted: 2013-02-20
Last updated: 2015-03-31
Results first posted: 2015-03-31

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Adverse Events Report	3 months of treatment	reports of treatment emergent adverse events

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Adverse Events Report	3 months of treatment		event	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Adverse Events Report	Dymista Nasal Spray		124		event
Adverse Events Report	Fluticasone Nasal Spray		37		event

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dymista Nasal Spray	304
Overall Study	STARTED	Fluticasone Propionate Nasal Spray	101
Overall Study	COMPLETED	Dymista Nasal Spray	285
Overall Study	COMPLETED	Fluticasone Propionate Nasal Spray	92
Overall Study	NOT COMPLETED	Dymista Nasal Spray	19
Overall Study	NOT COMPLETED	Fluticasone Propionate Nasal Spray	9

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	epistaxis	Respiratory, thoracic and mediastinal disorders	Dymista Nasal Spray	30	304
other	epistaxis	Respiratory, thoracic and mediastinal disorders	Fluticasone Propionate Nasal Spray	9	101
other	headache	General disorders	Dymista Nasal Spray	20	304
other	headache	General disorders	Fluticasone Propionate Nasal Spray	3	101
other	cough	Respiratory, thoracic and mediastinal disorders	Dymista Nasal Spray	11	304
other	cough	Respiratory, thoracic and mediastinal disorders	Fluticasone Propionate Nasal Spray	3	101
other	pyrexia	General disorders	Dymista Nasal Spray	10	304
other	pyrexia	General disorders	Fluticasone Propionate Nasal Spray	2	101
other	oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Dymista Nasal Spray	9	304
other	oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Fluticasone Propionate Nasal Spray	0	101

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dymista Nasal Spray
Total, all-cause mortality	Fluticasone Propionate Nasal Spray
Total, other adverse events	Dymista Nasal Spray	114	304
Total, other adverse events	Fluticasone Propionate Nasal Spray	25	101
Total, serious adverse events	Dymista Nasal Spray	1	304
Total, serious adverse events	Fluticasone Propionate Nasal Spray	0	101

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29490769	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Dymista Nasal Spray vs Fluticasone Propionate Nasal Spray: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01794741

GET https://conductscience.org/api/trials/v1/NCT01794741/registered

API reference For AI assistants