The Effcacy of Intranasal Budesonide and Leukotriene ModifierTherapy for Mild-moderate Pediatric Obstructive Sleep Apnean Hypopnea Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002963

Enrollment

Unknown

Registered

2012-09-19

Start date

2012-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obstructive Sleep Apnean Hypopnea Syndrome

Interventions

Montelukast:Montelukast Sodiuma 4mg or 5mg PO QN

Rhinocort:Rhinocort per puff per nostril to both nostrils b.i.d

Montelukast and Rhinocort:Rhinocort per puff per nostril to both nostrils b.i.d

Eligibility

Sex/Gender

All

Age

2 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Aged 2 to 14 years old; 2. BMI between 5-84% ile; 3. comply with mild - moderate OSAHS diagnostic criteria: (1) snoring and mouth breathing, and lie prone to sleep at night, bed-wetting; rhinitis, especially allergic rhinitis, clinical evidence of adenoid hypertrophy or tonsil hypertrophy; (2) OAI > 1 or AHI > 1.5, and the lowest blood oxygen saturation < 92%; AHI value between 1 and 20 or OAI value between 1 and 10.

Exclusion criteria

Exclusion criteria: 1. there are the special disease which cause pediatric OSAHS: (1) the nose: nasal cavity mass, nasal septum deviation, perforated nasal septum, and choanal atresia; (2) the nasopharynx and oropharynx: tongue body hypertrophy, obesity, pharyngeal and nasopharyngeal mass, pharyngeal obstruction after operation; (3) laryngeal and tracheal: congenital ]laryngomalacia, laryngeal web, throat cyst, laryngotracheal neoplasm, tracheostenosis; (4) cranial facial deformity: mid facial hypoplasia(Down Syndrome, Grouzon syndrome, achondroplasia); mandibular hypoplasia; (5) the factors influencing the neural regulation: the whole hypomyotonia (Down Syndrome, neuromuscular diseases), application of sedative drugs; 2. oral and intravenous hormones or antibiotics used nearly 4 weeks; 3. oral Montelukast Sodiuma nearly week; 4. Adenoidectomy and (or) Tonsillectomy history; 5. be allergic to the Montelukast Sodiuma and Rhinocort.

Design outcomes

Primary

Measure	Time frame
Overnight PSG Parameters;The level of urine LTE4;	—

Secondary

Measure	Time frame
A/N ratio;The score of OSA screening questionarie;	—

Countries

China

Contacts

Public ContactAihuan Chen

chaih163@163.com+86 020 83062032

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026