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Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis

NCT05626621 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-07-28

No results posted yet for this study

Summary

The goal of this clinical trial is to determine the best combination of drugs and drug delivery routes to treat surgically naive chronic rhinitis patients. The main question it aims to answer is:

Do high volume, high pressure delivery mechanisms in nasal irrigation improve the efficacy of azelastine combined with nasal steroid mometasone as compared to the standard low pressure, low volume delivery mechanisms in nasal sprays?

Subjects will complete six months of one of three medication regimens:

1. Saline irrigation followed by azelastine spray and mometasone spray
2. Mometasone saline irrigation
3. Azelastine saline irrigation combined with mometasone saline irrigation.

Conditions

  • Chronic Rhinitis

Interventions

DRUG

Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray

Participants will follow this medication regimen for 6 months.

DRUG

Mometasone Nasal Irrigation (1 mg capsule)

Participants will follow this medication regimen for 6 months.

DRUG

Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation

Participants will follow this medication regimen for 6 months.

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2025-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05626621 on ClinicalTrials.gov