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Antihistamine

Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis

Phase 1
Waitlist Available
Research Sponsored by Sandoz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment that combines two medications, mometasone furoate and azelastine hydrochloride. It targets adolescents and young adults who suffer from seasonal allergies. The treatment aims to reduce swelling and stop allergic reactions more effectively than using each medication alone.

Eligible Conditions
  • Hay Fever

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time 0 hours (prior to dosing), up to 48 or 72 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time 0 hours (prior to dosing), up to 48 or 72 hours post dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUCinf
AUCt
Cmax
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + AzelastineExperimental Treatment3 Interventions
Group II: Mometasone + Azelastine, then Mometasone Furoate, then Azelastine HydrochlorideExperimental Treatment3 Interventions
Group III: Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone FuroateExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mometasone Furoate
2005
Completed Phase 4
~190
Azelastine Hydrochloride
2021
Completed Phase 3
~210

Find a Location

Who is running the clinical trial?

SandozLead Sponsor
143 Previous Clinical Trials
26,237 Total Patients Enrolled

Media Library

Azelastine Hydrochloride (Antihistamine) Clinical Trial Eligibility Overview. Trial Name: NCT05887843 — Phase 1
Hay Fever Research Study Groups: Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride, Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine, Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate
Hay Fever Clinical Trial 2023: Azelastine Hydrochloride Highlights & Side Effects. Trial Name: NCT05887843 — Phase 1
Azelastine Hydrochloride (Antihistamine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05887843 — Phase 1
~15 spots leftby Dec 2025
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