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Effectiveness of Monteleukast in treatment of Adenoid Hypertrophy in Children

Evaluating effects of montelukast added to nasal mometasone in comparison to placebo in the treatment of children with adenoid hypertrophy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180718040520N1
Enrollment
120
Registered
2020-03-24
Start date
2018-04-21
Completion date
Unknown
Last updated
2020-04-21

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

Conditions

Adenoid Hypertrophy. Hypertrophy of adenoids

Interventions

Intervention 1: Intervention group: monteleukast tab daily 5 mg for 2 months plus nasal mometason daily. Patients are followed in clinic or on phone in two sessions.drug is produced in Abidi Pharmac

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: hypertrophy of adenoids confirmed clinically and radiologically Current use of nasal Mometason No contraindication for corticosteroids or monteleukast No previous adenoidectomy Patients and parents consent age 2 to 14 years

Exclusion criteria

Exclusion criteria: Allergic to nasal corticosteroids or antileukotriens Craniofacial, neuromuscular disorders or syndromes Acute upper respiratory tract infection Use of corticosteroids or antibiotics within last 2 weeks drug reactions requiring medication change patients who require surgical treatment while participating patient or parent refusal

Design outcomes

Primary

MeasureTime frame
Mouth breathing. Timepoint: before intervention and 1 months after and 2 months after intervention. Method of measurement: questionnaire.;Nasal Voice. Timepoint: before intervention and 1 months after and 2 months after intervention. Method of measurement: questionnaire.;Snoring. Timepoint: before intervention and 1 months after and 2 months after intervention. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBahar Pourroshani

Tehran University of Medical Sciences

bahar.pourroshani@gmail.com+98 21 8819 2716

Outcome results

None listed

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