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Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma

NCT04589663 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-13

Study results available
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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.

Conditions

Interventions

DRUG

Mometasone furoate

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

DRUG

QMF149

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

DRUG

Standard of Care (Soc)

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2022-04-11
Completion
2022-04-11

Countries

  • Hungary
  • South Africa

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589663 on ClinicalTrials.gov