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Dymista Allergen Chamber - Onset of Action Study

NCT04652245 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2023-03-23

Study results available
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Summary

This study is to assess the onset of action of fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU).

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3

Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 3

DRUG

Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5

Single dose, one spray in each nostril of Placebo nasal spray at Visit 5

DRUG

Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5

Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 5

DRUG

Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3

Single dose, one spray in each nostril of Placebo nasal spray, at Visit 3

Sponsors & Collaborators

  • MEDA Pharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Peter Couroux, Dr. · Cliantha Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2021-12-04
Completion
2021-12-13
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652245 on ClinicalTrials.gov