Trial intelligence / Profile preview

Inhaled Mometasone in Sickle Cell Disease

NCT03758950Phase 2

Key facts

Status: Completed
Start: Nov 2018
Primary completion: May 2023
Countries: 1
Modality: Orthosteric Ligands

Drugs: mometasone
Conditions: sickle cell disease (SCD)

Overview

Phase 2, randomised, triple-blind trial in sickle cell disease (SCD) comparing Mometasone with Placebo (2 arms). Primary endpoint: Soluble Vascular Cell Adhesion Molecule level at 1 year. Started Nov 2018; status: completed.

Design

2 arms

Study design: RandomizedTriple-blind

Mometasone
Inhaled Mometasone Furoate 220 mcg DPI once daily
Placebo
Once daily inhaled placebo

Who it enrols

Adults with severe SCD phenotypes and episodic cough/wheeze but no asthma, medically optimized on hydroxyurea.

Endpoints

Primary

Soluble Vascular Cell Adhesion Molecule level1 year

Secondary

Reticulocyte Count level1 year
Plasma Free Hemoglobin level1 year
Lactate Dehydrogenase level1 year
Bilirubin (Direct and Indirect) level1 year
Hemoglobin level1 year
Leukocyte Count level1 year
Platelet Count level1 year
Exhaled Nitric Oxide1 year

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