In breve
Clinical trials are investigating Indacaterol Acetate in children with asthma to see how well it works and how safe it is. The study compares QMF149, which includes Indacaterol Acetate, with budesonide and looks at lung function in children aged 6 to under 12 years.
Punti chiave
- Clinical trials are investigating Indacaterol Acetate in children with asthma. The main study is a Phase 3 interventional trial in boys and girls aged 6 to less than 12 years. It compares QMF149, which includes Indacaterol Acetate, with budesonide. The main endpoint is change in FEV1 at Week 12, which measures lung function. The trial is authorised and includes 194 participants.
Trial overview
This study is an interventional trial, which means researchers give one or more treatments and then compare the results. It is studying asthma in children and looking at whether QMF149, which includes Indacaterol Acetate, works better than budesonide for improving lung function.
Who can participate
The trial is designed for children from 6 to less than 12 years of age who have asthma. This means the study is focused on a pediatric population, so the findings are meant for children rather than adults.
What is being measured
The main outcome is the change from baseline in FEV1 at Week 12 of each treatment period. Baseline means the starting point before treatment begins, and FEV1 is a breathing test that shows how much air a child can blow out in one second. In simple words, the study wants to see if lung function improves after treatment.
Trial phase and status
This is a Phase 3 study. Phase 3 trials usually test how well a treatment works in a larger group and continue to check safety. The status is Authorised, which means the study has been approved to proceed.
Treatments being compared
The study compares QMF149 with budesonide. QMF149 is the name used in the trial for a combination that includes Indacaterol Acetate and mometasone furoate. The purpose of the comparison is to see whether QMF149 is better at improving lung function than the control treatment.
- QMF149: the study treatment being tested in this trial.
- Budesonide: the comparison treatment used to judge whether the study treatment works better.
- FEV1: the main breathing measure used to check lung function.
Why this study matters
Asthma can affect breathing in children, so studies like this try to find treatments that improve lung function in a reliable way. This trial adds information about Indacaterol Acetate in a specific age group and helps researchers compare it with an existing treatment approach. The enrolled group is 194 participants, which gives the study a defined sample size for evaluation.