Pharmacokinetics, pharmacodynamics, safety and tolerability of glycopyrronium (bromide) in children
Research type
Research Study
Full title
A Phase II, double-blind, randomized, multiple dose, cross over, three-treatment, three-period, six sequence placebo controlled trial to evaluate efficacy, pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of glycopyrronium (bromide) in children from 6 to less than 12 years of age with asthma
IRAS ID
1005061
Contact name
Cristiana Balcu
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-004972-32
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to examine the effect of the inhaled study treatment on breathing and to see how much of the drug is absorbed by the body. The outcome of this study will be used to determine the dose of glycopyrronium that may be combined later with two other drugs (indacaterol and mometasone) as a fixed-dose combination treatment (QVM149) delivered by a Breezhaler® inhaler. Once the optimal safe and effective dose of glycopyrronium is determined, the combination drug (QVM149) may be studied in a larger trial that will study how effective it is at treating children ≥ 6 years old and < 12 years old with moderate to severe asthma.
REC name
HSC REC B
REC reference
22/NI/0122
Date of REC Opinion
23 Sep 2022
REC opinion
Further Information Favourable Opinion