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A STUDY TO FIND OUT THE EFFECT OF INJECTION OMALIZUMAB AS COMPARED TO NASAL CORTICOSTEROIDS AND ANTIHISTAMINICS ON ADENOID HYPERTROPHY IN PEDIATRIC PATIENTS

A RANDOMISED CONTROLLED PILOT STUDY TO EVALUATE THE EFFECT OF SYSTEMIC OMALIZUMAB AS COMPARED TO THAT OF NASAL CORTICOSTEROIDS AND ANTIHISTAMINICS ON ADENOID HYPERTROPHY IN SYMPTOMATIC PEDIATRIC PATIENTS - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073324
Enrollment
40
Registered
2024-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: J352- Hypertrophy of adenoids

Interventions

Intervention1: Omalizumab: Inj Omalizumab subcutaneously 4 weekly for 3 doses dose based on body weight and serum IgE levels Control Intervention1: Nasal corticosteroid and oral antihistaminics: Aqueo

Sponsors

AIIMS DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 5 to 14 years Symptomatic adenoid hypertrophy with at least one of these symptoms like mouth breathing or snoring or nasal obstruction or OSA or OME or recurrent ASOM or sinusitis and grade 3 or 4 adenoid hypertrophy Serum IgE levels more than 50 IU per mL with or without allergic symptoms like excessive sneezing or rhinorrhea or atopy or itching

Exclusion criteria

Exclusion criteria: Obstructive sleep apnoea with Pulmonary hypertension or cor pulmonale Lysosomal storage disorders or any other diseases which mandate urgent need for surgical intervention for adenoid hypertrophy Adenoid hypertrophy and serous otitis media resulting in sensorineural hearing loss

Design outcomes

Primary

MeasureTime frame
Evaluation of the effect of nasal steroids and oral antihistaminics vs parenteral omalizumab on the nasopharyngoscopic findings in pediatric patients with symptomatic adenoid hypertrophyTimepoint: Baseline, 3 months and 6 months

Secondary

MeasureTime frame
Evaluation of the effect of nasal steroids and oralantihistaminics vs parenteral omalizumab on symptomatology.Timepoint: 3 months

Countries

India

Contacts

Public ContactDR MANPREET

AIIMS NEW DELHI

sagardrprem@gmail.com9868078734

Outcome results

None listed

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