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Intranasal Steroid and Antihistamine Combination

Dymista (fluticasone/azelastine) for Allergy or Hay Fever

Phase 4
Waitlist Available
Research Sponsored by University of Chicago
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 levels of ecp in the first nasal lavage of the challenge.there will be 3 consecutive challenges separated by 24 hrs and ecp will be measured in the first lavage of each challenge
Awards & highlights

Study Summary

Dymista, a combined product containing the antihistamine azelastine and the intranasal steroid fluticasone, provides superior clinical efficacy to both fluticasone propionate and azelastine hydrochloride in the treatment of seasonal allergic rhinitis. The superiority of efficacy not only occurs at the initiation of treatment, but persists for its duration. The mechanism underlying the superior efficacy of Dymista is not known. This trial focuses on examining the effects of Dymista on the dynamics of the allergic response in man using nasal provocation with antigen. The investigators will study the relationship between symptoms, physiology, cells and mediators.

Eligible Conditions
  • Allergy or Hay Fever

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~levels of ecp in the first nasal lavage of the challenge.there will be 3 consecutive challenges separated by 24 hrs and ecp will be measured in the first lavage of each challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and levels of ecp in the first nasal lavage of the challenge.there will be 3 consecutive challenges separated by 24 hrs and ecp will be measured in the first lavage of each challenge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Albumin level in nasal lavage
Secondary outcome measures
Sneezes after allergen challenge
Other outcome measures
Eosinophil cationic protein (ECP)
Eosinophils
Histamine
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Fluticasone propionateExperimental Treatment2 Interventions
Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista
Group II: Dymista (fluticasone/azelastine)Experimental Treatment2 Interventions
Dymista is also provided as a nasal spray in bottles similar to the other two agents
Group III: PlaceboPlacebo Group2 Interventions
Placebo nasal spray that is similar to Dymista in all respects except the active ingredient
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nasal Allergen Challenge
2015
Completed Early Phase 1
~30
Fluticasone propionate
FDA approved

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,757 Total Patients Enrolled

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
Evaluating Factors Involved in Dymista's Superior Clinical Efficacy to Fluticasone Propionate in the Treatment of Seasonal Allergic Rhinitis
2015. "Evaluating Factors Involved in Dymista's Superior Clinical Efficacy to Fluticasone Propionate in the Treatment of Seasonal Allergic Rhinitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02402465.
~2 spots leftby Apr 2025
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