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Antihistamine

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

Phase 4
Waitlist Available
Led By Peter Couroux, Dr.
Research Sponsored by MEDA Pharma GmbH & Co. KG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 4 hours post application
Awards & highlights

Study Summary

This study is evaluating whether a drug combination can be used to treat nasal symptoms of seasonal allergic rhinitis.

Eligible Conditions
  • Hay Fever

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 4 hours post application
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 4 hours post application for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient-assessed Instantaneous Total Nasal Symptom Score (TNSS) From Baseline Compared to Placebo
Secondary outcome measures
Change in Patient-assessed Instantaneous Total Ocular Symptom Score (TOSS) From Baseline Compared to Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment B (Placebo) and Treatment A (Dymista), separated by at least 14 days of wash-out periodExperimental Treatment2 Interventions
Placebo nasal spray and Fixed drug combination of Azelastine hydrochloride 137 μg / Fluticasone propionate 50 μg nasal spray
Group II: Treatment A (Dymista) and Treatment B (Placebo), separated by at least 14 days of wash-out periodExperimental Treatment2 Interventions
Fixed drug combination of Azelastine hydrochloride 137 μg / Fluticasone propionate 50 μg nasal spray and Placebo nasal spray
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3
2020
Completed Phase 4
~220
Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5
2020
Completed Phase 4
~220
Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5
2020
Completed Phase 4
~220
Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3
2020
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

MEDA Pharma GmbH & Co. KGLead Sponsor
29 Previous Clinical Trials
7,950 Total Patients Enrolled
Peter Couroux, Dr.Principal InvestigatorCliantha Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dymista Allergen Chamber - Onset of Action Study
2020. "Dymista Allergen Chamber - Onset of Action Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04652245.
~49 spots leftby May 2025
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