The effect of different dose of intranasal steroid with leukotriene inhibitor in snoring children with adenotonsilar hypertrophy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251212007

Enrollment

Registered

2025-12-12

Start date

2026-01-01

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

snoring, obstructive sleep apnea, sleep quality Adenotonsilar hypertrophy, OSA, child, intranasal steroid, montelukast

Interventions

-Randomized patient with diagnosis of adenotonsilar hypertrophy for 1 by 1 -using the fluticasone furoate 110 mcg/day with standard dose of montelukast at enrollment then continuous and follow up for

Experimental Drug,Experimental Drug

High-dose INS,Low-dose INS

Eligibility

Sex/Gender

All

Age

2 Years to 8 Years

Inclusion criteria

Inclusion criteria: children 2-8 years old with diagnosis of snoring form adenotonsilar hypertrophy

Exclusion criteria

Exclusion criteria: 1. Previouly received intranasal steroid or leukotriene inhibitor within 1 month. 2. Obesity (weight for height > 140 %) 3. Underlying diease of craniofacial anomaly 4. Previously received systemic steroid within 1 month 5. Steroid or montelukast drug allergy

Design outcomes

Primary

Measure	Time frame
obstructive sleep apnea score at enroll and during follow up at 4,8,12 weeks osa-18 score	—

Secondary

Measure	Time frame
sleep quality at enroll and during follow up at 4,8,12 weeks Pittsburgh Sleep Quality Index	—

Countries

Thailand

Contacts

Public ContactChutima Phuaksaman

Naresuan University

chutimaph@nu.ac.th0851888128

Outcome results

None listed

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