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Indacaterol

Clinical trials investigating Indacaterol are studied here through the trial data provided. The trials focus on treatment control, patient adherence, and clinical outcomes in people with asthma and chronic obstructive pulmonary disease (COPD). These studies mainly look at how well treatment works in real-life use and which patients can take part.

Table of contents

Trial overview

The source data includes two completed Phase 3 interventional trials that studied lung disease treatment in people with asthma and chronic obstructive pulmonary disease (COPD).[1][2]

The provided trial records do not describe Indacaterol as the main study drug in the trial titles, but Indacaterol-containing treatments appear in the intervention lists of the COPD study data.[2]

Asthma study: treatment use and control

The first study, NCT05626777, was a completed Phase 3 trial in people with asthma.[1]

This study compared two ways of giving mepolizumab after the sixth injection: a nurse-administered pre-filled syringe group and a self-administered auto-injector pen group.[1]

The main goal was to compare treatment compliance, which means how well patients used the study treatment as planned, and to compare the proportion of patients with controlled asthma after 6 months.[1]

The study used pharmacy records and monthly patient diaries to check compliance, and it used the ACT score to measure asthma control.[1]

COPD study: clinical control in high-risk patients

The second study, 2023-507304-32-00, was a completed Phase 3 trial in patients with chronic obstructive pulmonary disease.[2]

It studied whether Trelegy® could improve clinical control compared with LABA-LAMA treatment in high-risk GOLD B+ patients.[2]

Clinical control in this study was a validated composite endpoint, which means it combined more than one measure of disease control, including stability and impact.[2]

The primary outcome asked whether patients stayed persistently controlled at all study visits over months 3, 6, 9, and 12.[2]

The intervention list for this study included many inhaled COPD treatments, including Indacaterol-containing products such as Onbrez Breezhaler and Xoterna Breezhaler among many others listed in the source data.[2]

Study design, phases, and enrollment

Both studies were interventional, meaning researchers assigned treatments rather than only observing usual care.[1][2]

Both were Phase 3 studies, which are late-stage clinical trials used to compare treatments in larger groups of patients.[1][2]

The asthma study planned for 130 participants, while the COPD study planned for 1028 participants.[1][2]

Both trials were marked as completed in the source data.[1][2]

Main endpoints and what they mean

A primary outcome is the main result a trial wants to measure.[1][2]

In the asthma study, the primary outcomes were compliance and the proportion of patients with controlled asthma after 6 months.[1]

In the COPD study, the primary outcome was whether patients remained clinically controlled at every study visit during the 12-month study period.[2]

The asthma study used the ACT score, pharmacy accountability, and monthly diaries, while the COPD study used a composite endpoint based on stability and impact.[1][2]

Who the trials were designed for

The asthma trial was designed for people with asthma who were receiving mepolizumab treatment in one of two delivery methods.[1]

The COPD trial was designed for high-risk GOLD B+ patients with chronic obstructive pulmonary disease.[2]

Across the provided records, the focus is on patient groups where treatment use, follow-up, and symptom control can be measured over time.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05626777 Phase 3 Asthma Completed 130
2023-507304-32-00 Phase 3 Chronic Obstructive Pulmonary Disease Completed 1028

FAQ

  • What are the clinical trials about Indacaterol studying? The provided trials are not direct Indacaterol-only studies, but they include Indacaterol-containing treatment groups in COPD research. They look at clinical control, treatment comparison, and patient outcomes such as adherence and asthma or COPD control.
  • Who can take part in these trials? The trials focus on people with asthma or COPD. One study includes patients with asthma, and another includes high-risk GOLD B+ patients with COPD.
  • What phases are the trials in? Both trials are Phase 3 studies. This means they are late-stage trials that compare treatments in larger patient groups.
  • What outcomes are being measured? The studies measure treatment compliance, asthma control, and clinical control in COPD. They use tools such as patient diaries, pharmacy records, the ACT score, and a composite endpoint.
  • Are these trials completed? Yes. Both trials listed in the source data are marked as completed.

Ongoing Clinical Trials on Indacaterol

  • Study Comparing Trelegy with LABA-LAMA Drug Combination for Improving COPD Control in High-Risk Patients

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Asthma Control and Adherence with Mepolizumab in Pre-filled Devices for Patients with Asthma

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Asthma: A long-term lung condition that can cause wheezing, shortness of breath, chest tightness, and coughing.
  • Chronic Obstructive Pulmonary Disease (COPD): A long-term lung disease that makes it hard to breathe. It includes conditions that block airflow in the lungs.
  • Phase 3: A late stage of clinical research. These trials usually compare treatments in larger groups of people to see how well they work.
  • Interventional study: A trial in which researchers give a treatment or compare treatments to study the effects.
  • Enrollment: The number of people planned or included in a study.
  • Primary outcome: The main result the researchers want to measure.
  • Treatment compliance: How well patients follow the treatment plan and use the study treatment as directed.
  • Patient diary: A record kept by the patient to track treatment use or symptoms over time.
  • ACT score: A score used to check asthma control. Higher control means symptoms are better managed.
  • Composite endpoint: A main outcome made from more than one result, such as several measures of disease control.
  • Clinical control: A state where the disease is well managed based on set study criteria.
  • GOLD B+: A COPD patient group described by the study as high risk.

References