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Indacaterol Acetate

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.

Table of contents

Trial overview

This study is an interventional trial, which means researchers give one or more treatments and then compare the results.[1] It is studying asthma in children and looking at whether QMF149, which includes Indacaterol Acetate, works better than budesonide for improving lung function.[1]

Who can participate

The trial is designed for children from 6 to less than 12 years of age who have asthma.[1] This means the study is focused on a pediatric population, so the findings are meant for children rather than adults.[1]

What is being measured

The main outcome is the change from baseline in FEV1 at Week 12 of each treatment period.[1] 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.[1] In simple words, the study wants to see if lung function improves after treatment.[1]

Trial phase and status

This is a Phase 3 study.[1] Phase 3 trials usually test how well a treatment works in a larger group and continue to check safety.[1] The status is Authorised, which means the study has been approved to proceed.[1]

Treatments being compared

The study compares QMF149 with budesonide.[1] QMF149 is the name used in the trial for a combination that includes Indacaterol Acetate and mometasone furoate.[1] The purpose of the comparison is to see whether QMF149 is better at improving lung function than the control treatment.[1]

  • QMF149: the study treatment being tested in this trial.[1]
  • Budesonide: the comparison treatment used to judge whether the study treatment works better.[1]
  • FEV1: the main breathing measure used to check lung function.[1]

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.[1] This trial adds information about Indacaterol Acetate in a specific age group and helps researchers compare it with an existing treatment approach.[1] The enrolled group is 194 participants, which gives the study a defined sample size for evaluation.[1]

Trial ID Phase Condition studied Status Enrollment
2022-501899-26-00 Phase 3 Asthma in children 6 to less than 12 years old Authorised 194

FAQ

  • What is being studied in the clinical trial of Indacaterol Acetate? The trial is studying QMF149, which includes Indacaterol Acetate and mometasone furoate, in children with asthma. It compares this treatment with budesonide to see which helps lung function more.
  • Who can take part in this trial? The target group is children from 6 to less than 12 years of age who have asthma. The trial is designed for this specific age group.
  • What phase is the trial? This is a Phase 3 trial. Phase 3 trials usually look at how well a treatment works and continue to check safety in a larger group of people.
  • What is the main goal of the study? The main goal is to see whether QMF149 is better than budesonide at improving lung function. The study measures this by checking FEV1, a test that shows how much air a person can blow out in one second.
  • What is the status of the trial? The trial status is Authorised. This means the study has been approved to move forward.

Sperimentazioni cliniche in corso su Indacaterol Acetate

  • Studio sull’efficacia e sicurezza di indacaterolo acetato/mometasone furoato rispetto a budesonide nei bambini con asma di età compresa tra 6 e meno di 12 anni

    In arruolamento

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Austria Bulgaria Cechia Grecia Ungheria Italia +3

Glossario

  • Asthma: A long-term lung condition that can cause wheezing, coughing, chest tightness, and trouble breathing.
  • Phase 3: A later stage of clinical research where a treatment is tested in a larger group to see how well it works and to keep checking safety.
  • FEV1: A breathing test that measures how much air a person can force out in one second. It helps show how well the lungs are working.
  • Efficacy: How well a treatment works for the condition being studied.
  • Safety: Information about whether a treatment causes problems or unwanted effects.
  • Interventional study: A study in which researchers give a treatment or compare treatments to see what happens.
  • Budesonide: A treatment used as the comparison medicine in this study.
  • QMF149: The study treatment being tested in this trial; it includes Indacaterol Acetate and mometasone furoate.

Riferimenti