Comparison of Elonide and Nasonex nasal spray for the treatment of perennial allergic rhinitis

Phase 2

Active, not recruiting

• Conditions: Perennial Allergic Rhinitis, Allergic Rhinitis, SPT positive, indoor allergen; mometasone furoate, intranasal spray, perennial allergic rhinitis, PAR, dust mite, cockroach&#44

• Registration Number: TCTR20180828010
• Lead Sponsor: HOE Pharmaceuticals Sdn Bhd, Malaysia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-28
• Study Completion: 2019-09-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Moderate to severe symptoms with history nasal allergy at least 12 months, 2 or more symptoms: rhinorrhea, sneezing, itching, nasal obstruction, confirmed by skin prick test positive with a wheal diameter 3 mm to indoor allergen (mite, cockroach, mold)

Exclusion Criteria

Pregnancy, Upper and lower respiratory tract infection in 2 weeks prior to the study, Other nasal conditions causing nasal obstruction such as severe deviated nasal septum, nasal polyp, Using intranasal or oral steroids within 4 weeks before first visit, Using antihistamine, antileukotrienes within 2 weeks before first visit, Using decongestant within 1 day before first visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-inferior efficacy of Elonide nasal spray and Nasonex nasal spray 5 weeks Total nasal symptom score (TNSS),Non-inferior efficacy of Elonide nasal spray and Nasonex nasal spray 5 weeks Anterior rhinomanometry and Acousticrhinometry

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AE) baseline, Wk1, Wk3, Wk5 AE Report Form follow through TH-FDA guideline