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Salmeterol Xinafoate

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).

Table of contents

Trial overview

The available trial data show two interventional studies that include Salmeterol Xinafoate in research about lung disease.[1][2] One study is in children with asthma, and the other is in adults with chronic obstructive pulmonary disease, also called COPD.[1][2]

These trials are not simple description studies; they are designed to test treatment effects by comparing study groups.[1][2] The research focuses on how well the treatments work, and in the asthma study, also on safety and tolerability.[2]

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.[2] It is a Phase 2 study with 53 planned participants and is currently authorised.[2]

This study includes Salmeterol Xinafoate among the tested treatments, along with salbutamol, fluticasone propionate, NVA237, and placebo.[2] 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.[2]

The main goal is to evaluate the change from baseline in trough FEV1 at week 2 of each treatment period.[2] FEV1 is a lung function test that measures how much air a person can blow out in one second.[2]

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+).[1] It is a Phase 3 study with 1,028 participants and is listed as completed.[1]

This study is in people with Chronic Obstructive Pulmonary Disease, and the target group is high-risk GOLD B patients.[1] GOLD B is a COPD grouping used to describe patients with a higher symptom burden and a certain risk pattern.[1]

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.[1] 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.[1]

Main outcomes measured

The asthma study uses a lung function outcome, which is change in trough FEV1 at week 2 of each treatment period.[2] This type of endpoint helps researchers see whether a treatment changes how well the lungs work over time.[2]

The COPD study uses a clinical control outcome, which looks at whether patients stay controlled at every planned visit during the study.[1] Because the outcome is measured across several months, it gives a longer view of how stable the disease remains during treatment.[1]

Who can participate

Based on the trial data, the asthma study is for children aged 6 to less than 12 years with asthma.[2] The COPD study is for patients with chronic obstructive pulmonary disease who are in the high-risk GOLD B group.[1]

These are very different groups, so the studies are not meant for the same population.[1][2] One study focuses on children, while the other focuses on adults with COPD.[1][2]

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.[2] The COPD study is Phase 3, which usually means a larger group is used to compare treatment approaches more firmly.[1]

Both studies are interventional, meaning the researchers give treatments and measure the results.[1][2] This helps answer practical questions about treatment benefit in real patient groups.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-507304-32-00 Phase 3 Chronic Obstructive Pulmonary Disease Completed 1028
NCT05222529 Phase 2 Asthma Authorised 53

FAQ

  • What clinical trials are studying Salmeterol Xinafoate? The provided trial data includes one asthma study in children and one COPD study in adults. Salmeterol Xinafoate appears in the asthma trial as one of the tested treatments.
  • Who may take part in these trials? One trial is for children aged 6 to less than 12 years with asthma. The other trial is for high-risk COPD patients with GOLD B disease.
  • What is being measured in the trials? The asthma study measures change in trough FEV1, which is a lung function test. The COPD study measures whether patients stay clinically controlled at all study visits.
  • What phases are these trials? The asthma trial is Phase 2, which usually checks early signs of effect and safety. The COPD trial is Phase 3, which compares treatments in a larger patient group.
  • What conditions are being studied with Salmeterol Xinafoate? The trials focus on asthma and chronic obstructive pulmonary disease. They are designed to see how well the study treatments work in these conditions.

Ongoing Clinical Trials on Salmeterol Xinafoate

  • Study on Glycopyrronium Bromide for Children Aged 6-12 with Asthma

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Hungary Poland Spain

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Asthma: A long-term lung condition that can cause wheezing, coughing, chest tightness, and trouble breathing.
  • Chronic Obstructive Pulmonary Disease (COPD): A long-term lung disease that makes it hard to breathe and is often linked to blocked airflow.
  • GOLD B: A COPD group used to describe patients with a higher symptom burden and a certain risk pattern.
  • Interventional study: A clinical trial where researchers give treatments to see how they work.
  • Phase 2: An early trial phase that looks at whether a treatment may work and how safe it is.
  • Phase 3: A later trial phase that compares treatments in more people to confirm benefits and risks.
  • FEV1: Forced expiratory volume in one second; a test that shows how much air a person can blow out in one second.
  • Trough FEV1: The lowest FEV1 value measured before the next treatment dose or at a planned time point.
  • Primary outcome: The main result a trial is designed to measure.
  • Clinical control: How well a disease is kept stable under treatment, based on trial-defined criteria.
  • Composite endpoint: A result made from more than one measure, used together to judge treatment effect.

References

  1. https://clinicaltrials.gov/study/NCT04503460
  2. https://clinicaltrials.gov/study/NCT00102882
  3. https://clinicaltrials.gov/study/NCT01337336
  4. https://clinicaltrials.gov/study/NCT00394368
  5. https://clinicaltrials.gov/study/NCT01890863
  6. https://clinicaltrials.gov/study/NCT03461627