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EFFICACY OF INCREASED VERSUS STANDARD DOSAGE OF AZELASTINE/FLUTICASONE PROPIONATE NASAL SPRAY (DYMISTA) IN REDUCING SYMPTOMS IN PATIENTS WITH PERSISTENT ALLERGIC RHINITIS: A RANDOMIZED CONTROLLED TRIAL

EFFICACY OF INCREASED VERSUS STANDARD DOSAGE OF AZELASTINE/FLUTICASONE PROPIONATE NASAL SPRAY (DYMISTA) IN REDUCING SYMPTOMS IN PATIENTS WITH PERSISTENT ALLERGIC RHINITIS: A RANDOMIZED CONTROLLED TRIAL

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250502001
Enrollment
60
Registered
2025-05-02
Start date
2024-09-10
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with persistent allergic rhinitis Allergic rhinits, intranasal corticosteroid

Interventions

MP-AzeFlu nasal spray, 2 sprays per nostril twice daily (morning and evening), with the option to use up to 4 additional sprays per day as needed for symptom relief.,MP-AzeFlu nasal spray, 1 spray per
Experimental Drug,Experimental Drug
Increased dosage of Mp-AzeFlu,Standard dosage of MP-AzeFlu

Sponsors

Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Allergic rhinitis patients following diagnostic criteria of ARIA guideline14 2. Age >= 18 years 3. Visual Analog Scale (VAS) score >= 5, with persistent symptoms (greater than 4 weeks) 4. Not currently using intranasal corticosteroid for 2 weeks, systemic corticosteroid for four weeks, oral antihistamine for one week, nasal decongestant for one week, and leukotriene receptor antagonists for one week. 5. Diagnosis of AR was confirmed by skin prick test. Seven common allergens in Thailand were tested for sensitization, comprising Dermatophagoides farinae, Dermatophagoides pteronyssinus, cockroach, dog hair, cat hair, careless weed, and paragrass (AllerVACtest10, Greater Pharma, Bangkok, Thailand).

Exclusion criteria

Exclusion criteria: 1. Diagnosis of acute or chronic rhinosinusitis 2. AR and asthma requiring immunotherapy 3. Neoplasm of nasal and sinus mucosa 4. Previous surgery for nasal polyp or nasal septum deviation 5. Pregnancy and lactation 6. Refusal to participate

Design outcomes

Primary

MeasureTime frame
Symptom improvement Assessed daily over 7 days Visual analog scale

Secondary

MeasureTime frame
Symptom improvement Assessed daily over 7 days Total nasal symptom score, itchy eye symtpom

Countries

Thailand

Contacts

Public ContactSasicha Siriprapanukul

Faculty of Medicine, Chulalongkorn University

unna.ssl@gmail.com0832941242

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026