Table of contents

• Trials overview
• COPD studies
• Asthma studies
• Who can participate
• What the trials measure
• Study phases and trial size

Trials overview

The source data includes studies that investigate Salmeterol as part of inhaled treatment plans for people with breathing diseases.^[1] These trials focus on COPD, asthma, and wheezing in young children.^[1][2]

Most of the listed studies are Phase 3 trials, and one is a Phase 2 trial.^{[1][3] The studies are interventional, which means researchers assign a treatment and then observe the results.[1][3]}

COPD studies

One completed Phase 3 study looked at people with chronic obstructive pulmonary disease (COPD).^[1] It compared triple therapy with LABA-LAMA treatment in high-risk GOLD B patients, with the goal of improving clinical control.^[1]

In this study, the main outcome was whether patients stayed clinically controlled at all study visits across months 3, 6, 9, and 12.^[1] Clinical control was described as a composite endpoint, meaning it combines more than one measure into one overall result.^[1]

Asthma studies

Several trials focus on asthma, including uncontrolled asthma, partially controlled asthma, and asthma with wheezing in very young children.^{[2][3][4][5][6]}

One authorised Phase 3 trial studies children aged 2 to less than 6 years with asthma or asthmatic wheeze.^[2] It includes a treatment arm with SALMETEROL AND FLUTICASONE and compares dupilumab with placebo for severe asthma outcomes and safety.^[2]

A Phase 2 study in adults with moderate-to-severe T2-high asthma looked at loss of asthma control over 14 weeks.^[3] The study measured worsening control using criteria such as lower morning peak expiratory flow, more rescue inhaler use, higher inhaled corticosteroid dose, or asthma attacks needing systemic corticosteroids or urgent care.^[3]

Another Phase 3 study in adolescents and adults with uncontrolled asthma compared adding dupilumab to medium-dose ICS/LABA with increasing the ICS/LABA dose.^[4] Its main outcome was the annualized severe asthma exacerbation rate, which means how often severe flare-ups happen over a year.^[4]

A separate 52-week Phase 3 study in adolescents with treated uncontrolled asthma compared an experimental inhaler with Seretide Evohaler.^[5] The main result was change in pre-dose FEV1 at week 26, which is a lung function test that shows how much air a person can blow out in one second before taking medicine.^[5]

Another completed Phase 3 study examined treatment compliance and asthma control in people receiving mepolizumab, and it listed several inhaled treatments that include Salmeterol combinations among the comparator medicines.^[6] The study compared monthly nurse-administered treatment with self-administered treatment using an auto-injector pen.^[6]

Who can participate

Participation depends on the study and the condition being treated.^{[1][2][3][4][5][6]}

• Adults with COPD: one study included high-risk GOLD B patients with COPD.^[1]

• Young children: one study included children from age 2 to under 6 years with asthma or wheezing.^[2]

• Adults with asthma: one Phase 2 study enrolled adults with partially controlled moderate-to-severe T2-high asthma.^[3]

• Adolescents and adults with uncontrolled asthma: one Phase 3 study included these age groups.^[4]

• Adolescents with treated uncontrolled asthma: one 52-week Phase 3 study focused on adolescents.^[5]

What the trials measure

The trials measure different outcomes depending on the disease and study goal.^{[1][2][3][4][5][6]}

• Clinical control: one COPD study checked whether patients stayed controlled at all planned visits.^[1]

• Severe asthma exacerbations: several asthma studies measured how often serious flare-ups happened.^[2][4]

• Safety: one study measured treatment-emergent adverse events, serious adverse events, and events that led to stopping treatment.^[2]

• Loss of asthma control: one Phase 2 study used a set of rules such as worse peak flow, more reliever use, higher ICS dose, or asthma-related urgent care.^[3]

• FEV1: one trial measured change in lung function before dosing at week 26.^[5]

• Treatment compliance: one study checked whether patients used all planned doses and compared this between treatment groups.^[6]

Study phases and trial size

The source data shows both Phase 2 and Phase 3 research, with Phase 3 being the most common.^{[1][2][3][4][5][6]}

Trial sizes ranged from 100 participants in the Phase 2 asthma study to 1,028 participants in the COPD study.^{[1][3] Other studies enrolled 130, 146, 250, and 268 participants.[2][4][5][6]}

This mix of study sizes suggests that researchers are testing treatment effects in both smaller and larger patient groups.^{[1][3][4][5][6]}