Azelastine + Mometasone Irrigation/Spray for Chronic Rhinitis

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Endeavor Health

Must be taking: Azelastine, Mometasone

Must not be taking: Oral antihistamines, Oral steroids

Disqualifiers: Smokers, Pregnancy, Allergy to drugs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different delivery methods for two medications, azelastine (an antihistamine) and mometasone (a corticosteroid), for individuals with chronic rhinitis (persistent nasal inflammation). Researchers aim to determine if a high-volume, high-pressure nasal rinse is more effective than the usual low-pressure sprays. Participants will join one of three groups, each trying a different combination of medication delivery methods. Individuals with chronic rhinitis who seek a new treatment option and have not undergone surgery may be suitable candidates. As a Phase 4 trial, this research focuses on understanding how these FDA-approved treatments can benefit more patients.

Will I have to stop taking my current medications?

If you are taking oral antihistamines or oral steroids, you will need to stop them for a 4-week period before joining the trial. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

What is the safety track record for these treatments?

Research shows that azelastine and mometasone, used in nasal sprays and rinses, are generally safe for patients. Past studies found azelastine nasal spray to be safe, with only mild side effects like a bitter taste or slight drowsiness.

Mometasone, another important ingredient, is also considered safe. Studies have shown it to be effective and safe for regular use in treating conditions like chronic rhinitis, with users reporting few side effects.

Using azelastine and mometasone together in nasal rinses is similar to using them separately, and no major safety issues have emerged. Both drugs have FDA approval for treating chronic rhinitis, indicating a reliable safety record.

For those considering joining the trial, these treatments have been well-researched and are generally safe based on past studies. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for chronic rhinitis because they offer innovative methods of delivering medication directly to the affected areas. The azelastine and mometasone nasal spray combines two effective medications in a convenient spray form, which could enhance ease of use compared to separate applications. The azelastine and mometasone nasal irrigation introduces a novel approach by dissolving both medications into a saline rinse, potentially offering a more comprehensive treatment by flushing out allergens and applying medication simultaneously. Both methods target inflammation and allergy symptoms directly in the nasal passages, which might provide faster and more effective relief compared to standard oral antihistamines or nasal sprays used separately.

What evidence suggests that this trial's treatments could be effective for chronic rhinitis?

Research shows that using azelastine nasal spray twice daily can quickly relieve nasal symptoms like stuffiness and post-nasal drip. This trial will test one arm with a combination of azelastine and mometasone nasal spray, as studies have found that this combination works better than mometasone alone. Another arm will evaluate azelastine and mometasone nasal irrigation, as using a large volume of liquid in nasal rinses is more effective at relieving symptoms than regular nasal sprays, especially for long-term nasal issues. Mometasone nasal rinses, tested in a separate arm, have been shown to help with long-term nasal and sinus problems. Overall, both azelastine and mometasone are well-regarded for managing nasal symptoms, and using them in a rinse might enhance their effectiveness. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with chronic rhinitis.

I am an adult with chronic rhinitis and open to six months of topical treatment.

Exclusion Criteria

I haven't taken oral antihistamines or steroids in the last 4 weeks.

Allergy to study drugs.

Other medical conditions that the investigator believed would confound the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three medication regimens for chronic rhinitis over six months

24 weeks

3 visits (in-person) at 4, 12, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Azelastine
• Mometasone
• Nasal Irrigation
• Nasal Spray

Trial Overview 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.

How Is the Trial Designed?

Group I: Mometasone Nasal Irrigation Experimental Treatment 1 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 Irrigation Experimental Treatment 1 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 Spray Active Control 1 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.

Azelastine is already approved in United States, European Union for the following indications:

Approved in United States as Azelastine Hydrochloride for:

• Seasonal allergic rhinitis
• Perennial allergic rhinitis
• Nonallergic rhinitis

Approved in European Union as Azelastine Hydrochloride for:

• Seasonal allergic rhinitis
• Perennial allergic rhinitis

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Published Research Related to This Trial

Azelastine nasal spray effectively controlled symptoms of various types of rhinitis, with 78% to 90% of patients reporting symptom control after 2 weeks of treatment, particularly benefiting those with seasonal allergic rhinitis.

The treatment was well tolerated, with a low discontinuation rate of 2.3% due to adverse events, indicating its safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label evaluation of azelastine nasal spray in patients with seasonal allergic rhinitis and nonallergic vasomotor rhinitis. Lieberman, P., Kaliner, MA., Wheeler, WJ.[2015]

In a study of 16 patients, intranasal azelastine significantly relieved symptoms of seasonal allergic rhinitis compared to placebo, with notable improvements in sneezing and nasal itching.

In a larger comparison with 36 patients, azelastine showed similar efficacy to budesonide after two weeks, but uniquely alleviated ocular symptoms, and had a safety profile comparable to placebo with no significant increase in adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of azelastine nasal spray in patients with allergic rhinitis compared to placebo and budesonide. Dorow, P., Aurich, R., Petzold, U.[2012]

In a study involving 211 children under 13 years old, azelastine nasal spray significantly reduced symptoms of allergic rhinitis, with 98% of patients showing improvement in their overall symptom scores after treatment.

The treatment was well-tolerated, with 90% of patients reporting no adverse events, and 97% of physicians rating the overall tolerance as 'very good or good', confirming azelastine's safety and efficacy for managing allergic rhinitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the drug monitoring programme of azelastine hydrochloride nasal spray in the treatment of allergic rhinitis in children under 13 years of age. Wober, W., Diez Crespo, CD., Bähre, M.[2012]

In a study of 53 patients with otitis media with effusion (OME) and allergic rhinitis, those treated with azelastine hydrochloride (AZ) and S-carboxymethyl cysteine (SCMC) showed significant improvements in nasal symptoms over 8 weeks compared to those receiving SCMC alone.

While AZ did not directly improve ear symptoms associated with OME, it may have an indirect benefit by alleviating allergic rhinitis symptoms, suggesting a potential role in managing OME in allergic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of an antiallergic drug on otitis media with effusion in association with allergic rhinitis. Suzuki, M., Kawauchi, H., Mogi, G.[2019]

Azelastine hydrochloride nasal spray is the only prescription intranasal antihistamine in the USA approved for treating both seasonal allergic rhinitis and nonallergic vasomotor rhinitis, providing a targeted option for symptom relief.

With around 20 years of clinical use, azelastine has shown a favorable safety profile, making it a reliable choice for patients suffering from rhinitis-related discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the pharmacology, clinical efficacy, and safety of azelastine hydrochloride. La Force, C.[2010]

Azelastine nasal spray is an effective and rapid-acting treatment for seasonal allergic rhinitis (SAR) and nonallergic vasomotor rhinitis (VMR), showing significant improvement in nasal symptoms such as congestion and postnasal drip.

When used in combination with fluticasone propionate nasal spray, azelastine provides greater symptom relief than either medication alone, making it a beneficial option for patients with moderate-to-severe rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azelastine hydrochloride: a review of pharmacology, pharmacokinetics, clinical efficacy and tolerability. Bernstein, JA.[2012]

The new formulation of intranasal azelastine (Astepro) is safe and well tolerated over long-term use, showing a similar safety profile to the original formulation in a 1-year study with 862 patients.

Both formulations had comparable pharmacokinetic profiles and similar rates of treatment-emergent adverse events, indicating that the new formulation does not increase the risk of nasal irritation or other serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characteristics and safety and tolerability of a reformulated azelastine hydrochloride nasal spray in patients with chronic rhinitis. Berger, WE.[2019]

Azelastine nasal solution significantly improved symptoms of seasonal allergic rhinitis in a study of 247 patients aged 12 and older, with over 50% improvement in symptom severity scores compared to placebo.

The treatment was well-tolerated, with few adverse effects reported, none of which were serious, indicating a favorable safety profile for azelastine as an antiallergy medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of azelastine nasal solution in seasonal allergic rhinitis. Storms, WW., Pearlman, DS., Chervinsky, P., et al.[2012]

Azelastine hydrochloride, an H(1) antagonist, significantly relaxes tracheal smooth muscle contractions induced by methacholine, suggesting it may help alleviate respiratory symptoms in patients with rhinitis.

At high concentrations, azelastine appears to inhibit parasympathetic function in the trachea, which could potentially reduce asthma attacks in patients suffering from both rhinitis and asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azelastine nasal spray inhibiting parasympathetic function of tracheal smooth muscle. Wang, HW., Chou, YL., Chu, YH.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2621402/

Effectiveness of twice daily azelastine nasal spray in ... Azelastine nasal spray has a rapid onset of action, and improves nasal symptoms associated with rhinitis such as nasal congestion and post-nasal drip.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1939455124001534

In perennial allergic rhinitis, RQLQ is improved similarly by ... Some double-blind, placebo-controlled trials have shown that Azelastine (Aze) high dose (0.15%) was effective in seasonal (SAR) and perennial allergic ...

3. clinicaltrial.be clinicaltrial.be/en/details/84459?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Efficacy of Azelastine and Mometasone Irrigation in Compa... The purpose of this research is to determine whether patients with chronic rhinitis treated with mometasone and azelastine irrigations will ...

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The impact of nasal use of azelastine and mometasone ... Mometasone furoate, which has been used in clinical practice for many years, was reported to be a safe molecule and provides better control of nasal symptoms ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05626621

Efficacy of Azelastine and Mometasone Irrigation in ... The purpose of this research is to determine whether patients with chronic rhinitis treated with mometasone and azelastine irrigations will show significant ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/213872Orig1s000IntegratedR.pdf

213872Orig1s000 - accessdata.fda.gov azelastine nasal spray) or mometasone furoate (Nasonex). A listing of the studies that provided safety data in the SAR and PAR studies are provided in Table ...

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A Study to Evaluate the Safety and Tolerability of a Nasal ... The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride ) is as safe as mometasone furoate (nasonex) alone. Official ...