CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Mometasone furoate +2 moredrug
Likely dose
Mometasone furoate 100 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04589663
NCT04589663Phase 2Completed
CompareCT.gov

An Open-label, Two-period, Single-sequence, Crossover Study to Compare the Systemic Exposure of a Single Inhaled Dose of Mometasone Furoate (MF) When Administered Alone Via the MF Twisthaler® (TH) to a Single Inhaled Dose of QMF149 Indacaterol Acetate/MF Fixed Dose Combination When Administered Via the Concept 1 (C1) Breezhaler® Device in ≥ 6 to < 12 Year Old Asthma Patients

Novartis Pharmaceuticals·interventional·Posted Oct 19, 2020·Updated Oct 13, 2023

In Brief

A Phase 2 clinical trial evaluating Mometasone furoate, QMF149, and 1 other intervention for Asthma. Completed, enrolled 24 participants across 3 sites in 2 countries.

Detailed Summary

This clinical study was designed to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed dose combination (QMF149) via the Concept 1 (C1) device in pediatric asthma patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesHungary, South Africa
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedOct 19, 2020
Enrollment StartJun 7, 2021
Primary CompletionApr 11, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.7 years ago

Interventions

Mometasone furoatedrug

Single inhaled dose of 100 µg mometasone furoate (MF) administered via Twisthaler® on Day 1

QMF149drug

Single inhaled dose of QMF149 (75/40 µg indacaterol acetate/MF fixed dose combination) administered via Concept 1 device on Day 6-9

Standard of Care (Soc)drug

Asthma therapy: budesonide and salbutamol being the most frequently used (excluding MF and indacaterol acetate)