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Efficacy of As-needed versus Regular Use of MP-AzeFlu in Moderate-to-severe Allergic Rhinitis: A randomized controlled non-inferiority trial

Efficacy of As-needed versus Regular Use of MP-AzeFlu in Moderate-to-severe Allergic Rhinitis: A randomized controlled non-inferiority trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230729001
Enrollment
60
Registered
2023-07-29
Start date
2023-10-24
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

Efficacy of As-needed versus Regular Use of MP-AzeFlu in Moderate-to-severe Allergic Rhinitis: A randomized controlled trial MPAzeFlu Azelastine Hydrochloride and Fluticasone Proprionate rTNSS RCQ36 GRADE Rhinomanometry Moderate-to-severe Allergic Rhinitis

Interventions

2 week of regular used MPAzeFlu then 4 week of as needed used of MPAzeFlu,2 week of regular used MPAzeFlu then 4 week of regular used of MPAzeFlu
Experimental Drug,Experimental Drug
AsneededMPAzeFlu,RegularusedofMPAzeFlu

Sponsors

Department of Otolaryngology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - >18 years old - baseline VAS score > 5 - not have used oral or intranasal antihistamines, anti-leukotrienes, inhaled or intranasal corticosteroids, or oral and intranasal decongestants within two weeks prior to the study.

Exclusion criteria

Exclusion criteria: rhinosinusitis, nasal polyps, or significant septal deviation. Those who have used oral corticosteroids within the past 30 days or have a history of current or prior immunotherapy are also ineligible. Additionally, patients with known allergies to MP-AzeFlu, as well as pregnant or breastfeeding individuals, are excluded.

Design outcomes

Primary

MeasureTime frame
mean difference of TNSS in between as-needed used and regular used 6 weeks data record

Secondary

MeasureTime frame
mean difference of individual nasal symptom scores in between as-needed used and regular used 6 weeks Data record,mean difference of VAS in between as-needed used and regular used 6 weeks data record,mean difference of RCQ-36 between as-needed use and regular use 6 weeks data record,mean difference of PNIF between as-needed use and regular use 6 weeks data record

Countries

Thailand

Contacts

Public ContactSaroj Suriwongse

Faculty of medicine ramathibodi hospital, mahidol university

tuner941@gmail.com0864096866

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026