Table of Contents

• Trial overview
• Asthma studies
• COPD studies
• Other conditions studied
• Study designs and participants
• Endpoints measured
• What Salbutamol means in these trials

Trial overview

The trial data show that Salbutamol is being used in studies across several conditions, not just one disease.^[1] Most of the trials are in asthma and COPD, with other studies in congenital myopathy, hyperkalemia, chronic pulmonary aspergillosis, and food allergy.^[1]

Many of the studies are Phase 3 trials, which usually means the treatment is being tested in larger groups to learn more about how well it works and how safe it is.^[1] One study is Phase 2, and one COPD study is listed as Low Intervention.^[1]

Asthma studies

Several trials include people with asthma, including children aged 2 to less than 6 years, children aged 6 to less than 12 years, adults with moderate-to-severe uncontrolled asthma, and adults and adolescents with severe and inadequately controlled asthma.^[1]

In these asthma studies, Salbutamol is often one of the inhaled treatments used in the trial design, sometimes alongside placebo or other asthma medicines.^[1] The main goals are to improve lung function, reduce severe asthma flare-ups, and compare different inhaler treatments over weeks or months.^[1]

• Children with asthma are included in studies that measure change in FEV1, which is a breathing test that shows how much air a person can blow out in one second.^[1]
• Adults with uncontrolled asthma are studied to see whether new treatments improve lung function or delay asthma events, with Salbutamol used as part of the study plan.^[1]
• Severe asthma studies look at both lung function and the rate of severe exacerbations, which means serious flare-ups that need extra treatment.^[1]

COPD studies

Several trials focus on COPD, a long-term lung disease that can make breathing difficult and can lead to flare-ups.^[1] These studies include people with moderate to severe COPD and those with a history of exacerbations, meaning past flare-ups.^[1]

In COPD trials, Salbutamol is used in inhalation form as part of the comparison or treatment setup.^[1] The main outcomes often look at lung function, exercise-related breathing measures, or the time until a first severe heart or COPD event.^[1]

• Exercise and lung function studies measure whether treatment improves breathing during activity and reduces dynamic hyperinflation, which means too much air stays trapped in the lungs.^[1]
• Cardiopulmonary outcome studies track serious heart or COPD events over time in large groups of participants.^[1]
• Long-term COPD studies look at severe exacerbation rates in former smokers with COPD.^[1]

Other conditions studied

One Phase 3 study in congenital myopathy enrolled 20 participants and aimed to improve muscle strength and muscle function.^[1] The main outcome was the change in the MFM32 score after 6 months of treatment compared with no treatment.^[1]

Another Phase 3 trial studied hyperkalemia, which means high potassium in the blood, in emergency departments.^[1] This study compared nebulized Salbutamol, insulin/dextrose infusion, and the combination of both, and measured the change in serum potassium after 60 minutes.^[1]

A Phase 3 study in chronic pulmonary aspergillosis included non- or mildly immunocompromised patients and looked at a 6-month treatment result based on clinical and radiological improvement.^[1] Salbutamol appears in the intervention list for this study as part of the treatment setup.^[1]

One food allergy extension study also listed Salbutamol among its interventions, while its main purpose was long-term safety and tolerability of ligelizumab.^[1]

Study designs and participants

The trials use different study designs, including interventional studies, randomised studies, placebo-controlled studies, double-blind studies, and active-controlled studies.^[1] These designs help researchers compare treatments in a fair way and reduce bias, which means reducing the chance that the results are influenced by expectations.^[1]

Participants range from young children to older adults, depending on the condition being studied.^[1] Some studies are very large, such as the COPD trial with 5,000 participants, while others are much smaller, such as the congenital myopathy study with 20 participants.^[1]

• Children are included in asthma studies that focus on lung function and safety.^[1]
• Adults are included in asthma, COPD, hyperkalemia, and chronic pulmonary aspergillosis studies.^[1]
• Former smokers and older adults are important groups in some COPD studies.^[1]

Endpoints measured

Trials use endpoints, which are the main results the researchers want to measure.^[1] In the Salbutamol trial data, endpoints include FEV1, MFM32, serum potassium change, annualized exacerbation rate, time to first event, and mucus scores.^[1]

• FEV1 is used in many asthma and COPD studies to measure lung function after treatment.^[1]
• MFM32 is used in congenital myopathy to measure muscle function over time.^[1]
• Serum potassium is used in hyperkalemia to see how quickly treatment lowers high potassium levels.^[1]
• Exacerbation rate measures how often serious disease flare-ups happen during the study period.^[1]
• Mucus score is used in one COPD study to assess airway mucus plugging on scans.^[1]

What Salbutamol means in these trials

In this trial set, Salbutamol is not always the main medicine being tested.^[1] In some studies it is part of the comparison group, in some it is used as a rescue or standard treatment, and in others it appears in the intervention list while another drug is the main focus.^[1]

This means the clinical research is looking at Salbutamol in different real-world trial settings, especially where breathing symptoms, lung function, or urgent treatment are important.^[1] The trial data show a broad research use across respiratory disease and a few non-respiratory conditions.^[1]