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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

NCT05887843 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-09-28

No results posted yet for this study

Summary

This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Mometasone + Azelastine

Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril

DRUG

Mometasone Furoate

Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril

DRUG

Azelastine Hydrochloride

Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2023-09-08
Completion
2023-09-08

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT05887843 on ClinicalTrials.gov