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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEndeavor Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults 18 years and older seeking treatment for chronic rhinitis and willing to undergo six months of topical therapy.

Diagnosis of Chronic Rhinitis.

Disqualifiers

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

Use of oral antihistamines or oral steroids, unless patient undergoes a 4 week washout period.

Smokers (tobacco, marijuana, vaping, etc.).

Known or suspected pregnancy, or lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    Participants will follow this medication regimen for 6 months.

  • Mometasone Nasal Irrigation (1 mg capsule)

    Drug

    Participants will follow this medication regimen for 6 months.

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

    Drug

    Participants will follow this medication regimen for 6 months.

Treatment groups

81 Participants
are divided into 3 treatment groups
Group A: Azelastine and Mometasone Nasal SprayActive comparator 1 intervention
Group B: Mometasone Nasal IrrigationExperimental treatment 1 intervention
Group C: Azelastine and Mometasone Nasal IrrigationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Sino-Nasal Outcome Test (SNOT-22) scores will be measured at baseline, 1 month, 3 months, and 6 months. Scores will be compared between three arms. The Sino-Nasal Outcome Test is a self-administered questionnaire that is used to assess nasal symptoms using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 consists of 22 questions, rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores indicating worse symptoms.

Time frame
Baseline, 1 month, 3 months, 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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