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NCT02402465 · ClinicalTrials.gov registry record · Phase 4
Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis
A Phase 4 study of Allergic Rhinitis, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT02402465: Completed Phase 4 study of Allergic Rhinitis, sponsored by University of Chicago.
NCT02402465 is a Phase 4 study of Allergic Rhinitis that has completed, run by University of Chicago. The registered enrollment target is 22 participants, below the 104-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02402465, a Phase 4 study of Allergic Rhinitis, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (albumin amount in lavage after 1st allergen exposure - amount after sham) + (amount in lavage after 2nd exposure - sham amount).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate
- DRUG Fluticasone/Azelastine nasal spray
- PROCEDURE Nasal Allergen Challenge
Study Locations (1)
Illinois
- The University of Chicago Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-02 |
| Est. Completion | 2020-02 |
| Phase | Phase 4 |
What the finished NCT02402465 record still lists
NCT02402465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 104-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Allergic Rhinitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02402465 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02402465 about?
NCT02402465 is a clinical study titled "Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis". 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 t...
What is the current status of trial NCT02402465?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2015-02. Estimated completion is 2020-02.
What conditions does trial NCT02402465 study?
This clinical trial studies the following conditions: Allergic Rhinitis.
What interventions are being tested in trial NCT02402465?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate (DRUG), Fluticasone/Azelastine nasal spray (DRUG), Nasal Allergen Challenge (PROCEDURE).
Who is sponsoring clinical trial NCT02402465?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02402465 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02402465's enrollment target sits among peer trials
22 18th of 23 higher than 4 of 23 other Allergic Rhinitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Allergic Rhinitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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