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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

Asthma Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

This study was an open-label, two-period, single-sequence crossover study that consisted of four distinct study periods: - Screening: Participants underwent a screening period of up to 14 days where were assessed for eligibility. - First Treatment: On the first treatment visit (Day 1) participants received a single inhaled dose of 100 μg MF administered via the TH device followed by a 4-7-day washout period. - Second Treatment: On the second treatment visit (Day 6-9) participants received a single inhaled dose of 75/40 μg indacaterol acetate/MF fixed dose combination (FDC) (QMF149) via C1 (Breezhaler®) device. Participants were allowed to use rescue medication (as needed) and potentially their Standard of Care (SoC) asthma therapy (excluding MF and indacaterol acetate). - Safety Follow-up: Upon completion of the treatment period, participants were followed up for safety assessments for 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04589663
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date June 7, 2021
Completion date April 11, 2022
View Details
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