In short
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.
Key points
- Clinical trials involving Indacaterol in the provided data are focused on asthma and chronic obstructive pulmonary disease (COPD). Both studies are Phase 3 and were completed. One trial in asthma looked at treatment compliance and asthma control over 6 months, while the COPD trial compared clinical control between treatment groups in high-risk GOLD B+ patients. The studies used patient diaries, pharmacy records, and control scores as key measures. Overall, the trial data focus on how well treatment works and how reliably patients use it in real-world settings.
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).
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.
Asthma study: treatment use and control
The first study, NCT05626777, was a completed Phase 3 trial in people with asthma.
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.
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.
The study used pharmacy records and monthly patient diaries to check compliance, and it used the ACT score to measure asthma control.
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.
It studied whether Trelegy® could improve clinical control compared with LABA-LAMA treatment in high-risk GOLD B+ patients.
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.
The primary outcome asked whether patients stayed persistently controlled at all study visits over months 3, 6, 9, and 12.
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.
Study design, phases, and enrollment
Both studies were interventional, meaning researchers assigned treatments rather than only observing usual care.
Both were Phase 3 studies, which are late-stage clinical trials used to compare treatments in larger groups of patients.
The asthma study planned for 130 participants, while the COPD study planned for 1028 participants.
Both trials were marked as completed in the source data.
Main endpoints and what they mean
A primary outcome is the main result a trial wants to measure.
In the asthma study, the primary outcomes were compliance and the proportion of patients with controlled asthma after 6 months.
In the COPD study, the primary outcome was whether patients remained clinically controlled at every study visit during the 12-month study period.
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.
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.
The COPD trial was designed for high-risk GOLD B+ patients with chronic obstructive pulmonary disease.
Across the provided records, the focus is on patient groups where treatment use, follow-up, and symptom control can be measured over time.