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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180828010
Enrollment
70
Registered
2018-08-28
Start date
2018-09-17
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

Perennial Allergic Rhinitis&#44

Interventions

50 mcg/puff&#44
use 2 puffs per nostril once daily from day 1 to day 35 continuously. (Arm 1 are randomized to experimental drug (Elonide NS as generic drug),50 mcg/puff&#44
use 2 puffs per nostril once daily from day 1 to day 35 continuously. (Arm 2 are randomized to active comparator drug (Nasonex NS as innovator drug)
Experimental Drug,Active Comparator Drug
Mometasone furoate nasal spray (generic),Mometasone furoate nasal spray (innovator)

Sponsors

HOE Pharmaceuticals Sdn Bhd, Malaysia
Lead Sponsor
Zuellig Pharma Ltd. Bangkok&#44
Collaborator
Thailand
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Non-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

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

Countries

Thailand

Contacts

Public ContactSukhumarn Chaisawat

Faculty of Medicine, Chulalongkorn University

skmuey168@gmail.com0954615932

Outcome results

None listed

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