In short
Clinical trials investigating Salmeterol Xinafoate are studying its role in asthma research and in a COPD trial that includes it as part of treatment comparisons. These studies look at outcomes such as lung function, clinical control, safety, and tolerability in specific patient groups, including children with asthma and adults with chronic obstructive pulmonary disease (COPD).
Key points
- Clinical trials investigating Salmeterol Xinafoate are focused on asthma and chronic obstructive pulmonary disease (COPD). One Phase 2 study looks at children 6 to less than 12 years old with asthma and measures lung function using trough FEV1. Another Phase 3 study looks at high-risk COPD patients with GOLD B disease and measures whether patients stay clinically controlled across study visits. The trials use interventional designs, meaning treatments are given and compared directly. The data show that researchers are studying both effectiveness and practical disease control in specific patient groups. The studies include both early and later phase research.
Trial overview
The available trial data show two interventional studies that include Salmeterol Xinafoate in research about lung disease. One study is in children with asthma, and the other is in adults with chronic obstructive pulmonary disease, also called COPD.
These trials are not simple description studies; they are designed to test treatment effects by comparing study groups. The research focuses on how well the treatments work, and in the asthma study, also on safety and tolerability.
Asthma study in children
The asthma trial is titled Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma. It is a Phase 2 study with 53 planned participants and is currently authorised.
This study includes Salmeterol Xinafoate among the tested treatments, along with salbutamol, fluticasone propionate, NVA237, and placebo. The source data do not say that Salmeterol Xinafoate is the only treatment being tested, so it should be understood as part of a broader comparison study.
The main goal is to evaluate the change from baseline in trough FEV1 at week 2 of each treatment period. FEV1 is a lung function test that measures how much air a person can blow out in one second.
COPD study in high-risk GOLD B patients
The COPD trial is titled THE ANTES B+ STUDY: AN OPEN-LABEL, PRAGMATIC, RANDOMIZED, CONTROLLED TRIAL OF TRIPLE THERAPY VERSUS LABA-LAMA COMBINATION TO IMPROVE CLINICAL CONTROL IN HIGH-RISK GOLD B PATIENTS (B+). It is a Phase 3 study with 1,028 participants and is listed as completed.
This study is in people with Chronic Obstructive Pulmonary Disease, and the target group is high-risk GOLD B patients. GOLD B is a COPD grouping used to describe patients with a higher symptom burden and a certain risk pattern.
The primary outcome is whether there is an association between treatment and being persistently controlled by clinical control at all study visits, with control assessed at months 3, 6, 9, and 12. The trial brief summary says the study compares Trelegy® versus LABA-LAMA treatment to improve clinical control, which is described as a validated composite endpoint with two domains: stability and impact.
Main outcomes measured
The asthma study uses a lung function outcome, which is change in trough FEV1 at week 2 of each treatment period. This type of endpoint helps researchers see whether a treatment changes how well the lungs work over time.
The COPD study uses a clinical control outcome, which looks at whether patients stay controlled at every planned visit during the study. Because the outcome is measured across several months, it gives a longer view of how stable the disease remains during treatment.
Who can participate
Based on the trial data, the asthma study is for children aged 6 to less than 12 years with asthma. The COPD study is for patients with chronic obstructive pulmonary disease who are in the high-risk GOLD B group.
These are very different groups, so the studies are not meant for the same population. One study focuses on children, while the other focuses on adults with COPD.
What the trial phases mean
The asthma study is Phase 2, which usually means researchers are looking for early signs that a treatment may work and checking safety-related information. The COPD study is Phase 3, which usually means a larger group is used to compare treatment approaches more firmly.
Both studies are interventional, meaning the researchers give treatments and measure the results. This helps answer practical questions about treatment benefit in real patient groups.