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MAZ-101 in persistent allergic rhinitis
NCT05684380Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2024
- Primary completion
- Nov 2024
- Sponsor
- EMS
- Modality
- Orthosteric Ligands
- Drugs
- mometasoneazelastine
- Conditions
- allergic rhinitis (AR)
01
Overview
Phase 3, randomised, double-blind trial of mometasone and azelastine in allergic rhinitis (AR) (2 arms), sponsored by EMS. Primary endpoint: Reflective Total Nasal Symptom Score at 28 days. Planned start Sep 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
MAZ-101
Mometasone furoate + Azelastine hydrochloride (Experimental)
DYMISTA
Fluticasone propionate + Azelastine hydrochloride (Active Comparator)
03
Who it enrols
Patients aged 12+ with moderate-severe persistent allergic rhinitis for at least 1 year, demonstrating significant nasal symptoms (TNSS >= 8) during screening and lead-in. Excludes patients with asthma, nasal polyps, severe cardiovascular or ocular conditions, or those using interfering medications.
04
Endpoints
Primary
Reflective Total Nasal Symptom Score
Secondary
Reflective Total Ocular Symptom Score
Reflective Total Nasal and Ocular Symptom Score
Reflective Individual Nasal Symptom Scores
Reflective Individual Ocular Symptom Scores
Rhinoconjunctivitis Quality of Life Questionnaire
Number of days without nasal symptoms
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