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Antihistamine

Azelastine + Mometasone Irrigation/Spray for Chronic Rhinitis

Phase 4

Recruiting

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Chronic Rhinitis.

Be older than 18 years old

Must not have

The patient has diagnosis(es) other than chronic rhinitis that can account for his/her symptoms (septal deviation, nasal valve collapse, chronic sinusitis).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 months, 6 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to find the best combo of drugs & delivery methods to treat chronic rhinitis. It'll compare 3 med regimens: irrigation & sprays of saline, azelastine & mometasone.

Who is the study for?

Adults over 18 with chronic rhinitis who haven't had surgery for it can join this trial. They must be willing to try topical treatments for six months. People allergic to the drugs being tested, pregnant or breastfeeding women, smokers, and those on oral antihistamines or steroids (unless they stop these medications for four weeks) cannot participate.

What is being tested?

The study is testing if high volume nasal irrigation with a combination of Azelastine and Mometasone is more effective than standard nasal sprays in treating chronic rhinitis. Participants will follow one of three treatment plans involving different combinations and delivery methods of these medications over six months.

What are the potential side effects?

Possible side effects include irritation inside the nose, sneezing, nosebleeds, headache, bitter taste in mouth after use of azelastine spray/irrigation; mometasone may cause similar nasal irritation as well as throat irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic rhinitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have conditions like a deviated septum or sinusitis causing my symptoms, not just chronic rhinitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Mometasone Nasal IrrigationExperimental Treatment1 Intervention

The study intervention will be mometasone (1 mg/capsule). Participants will be required to dissolve the contents of the capsule into a 240 mL sinus rinse bottle along with the salt packet to create the rinse solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the rinse solution for each side.

Group II: Azelastine and Mometasone Nasal IrrigationExperimental Treatment1 Intervention

The study intervention will be azelastine (1mg) and mometasone (1 mg). The azelastine and mometasone will be provided in one capsule identical to the mometasone capsule. Participants will be required to dissolve the contents of the capsule into a 240 mL sinus rinse bottle along with the salt packet to create the rinse solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the rinse solution for each side.

Group III: Azelastine and Mometasone Nasal SprayActive Control1 Intervention

The study intervention will be saline irrigation (240 mL) followed by azelastine spray (137 mcg/spray) and mometasone spray (50 mcg/spray). Participants will have to dissolve the salt packet in a 240 mL sinus rinse bottle to create the saline solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the saline solution for each side followed by 2 sprays per nostril of both of the nasal sprays.

0 / 2Eligibility criteria met