Trial intelligence / Profile preview

RAISe: Mometasone for Chronic Rhinosinusitis and Asthma in Children

NCT03011632Phase 4

Key facts

Status: Completed
Start: Jan 2017
Primary completion: Aug 2019
Countries: 1
Sponsor: Medical University of Lodz
Modality: Nanoparticles, Small Molecules

Drugs: Mometasone furoate nano-nasal spray
Conditions: chronic rhinosinusitis (CRS)asthma

Overview

Phase 4, randomised, double-blind trial of Mometasone furoate nano-nasal spray in chronic rhinosinusitis (CRS) and asthma (2 arms), sponsored by Medical University of Lodz. Primary endpoints: Childhood Asthma Control Test at 12 months and Sinusitis Symptom Score at 12 months. Started Jan 2017; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Mometasone Nasal
Intranasal mometasone once daily for 3 months plus saline nebulization.
Placebo Mometasone
Placebo nasal spray once daily for 3 months plus saline nebulization.

Who it enrols

Children with chronic rhinosinusitis and/or asthma, including a healthy control group. Excludes those with obesity, tobacco smoke exposure, immunodeficiency, or severe tonsil hypertrophy.

Endpoints

Primary

Childhood Asthma Control Test12 months
Sinusitis Symptom Score12 months

Secondary

Spirometry12 months
Nasal fraction of exhaled nitric oxide12 months
Glucose concentration12 months
Immunophenotyping12 months
quantitative polymerase chain reaction12 months

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