In short
Clinical trials are studying Salbutamol in several different conditions, including asthma, chronic obstructive pulmonary disease (COPD), congenital myopathy, hyperkalemia, and chronic pulmonary aspergillosis. These studies look at outcomes such as lung function, muscle function, and potassium levels, and include children, adults, and older adults.
Key points
- Clinical trials involving Salbutamol in this data cover several different health problems, especially asthma and COPD, but also congenital myopathy, hyperkalemia, and chronic pulmonary aspergillosis. Most studies are Phase 3, with one Phase 2 study and one low-intervention study. The target groups include children, adults, and older adults, depending on the condition being studied. Trial goals include measuring lung function, muscle function, potassium reduction, and disease flare-ups. In several studies, Salbutamol is used as a comparison or rescue treatment rather than the main experimental drug. The studies use endpoints such as FEV1, MFM32, time to first event, and serum potassium change.
Trial overview
The trial data show that Salbutamol is being used in studies across several conditions, not just one disease. Most of the trials are in asthma and COPD, with other studies in congenital myopathy, hyperkalemia, chronic pulmonary aspergillosis, and food allergy.
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. One study is Phase 2, and one COPD study is listed as Low Intervention.
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.
In these asthma studies, Salbutamol is often one of the inhaled treatments used in the trial design, sometimes alongside placebo or other asthma medicines. The main goals are to improve lung function, reduce severe asthma flare-ups, and compare different inhaler treatments over weeks or months.
- 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.
- 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.
- Severe asthma studies look at both lung function and the rate of severe exacerbations, which means serious flare-ups that need extra treatment.
COPD studies
Several trials focus on COPD, a long-term lung disease that can make breathing difficult and can lead to flare-ups. These studies include people with moderate to severe COPD and those with a history of exacerbations, meaning past flare-ups.
In COPD trials, Salbutamol is used in inhalation form as part of the comparison or treatment setup. The main outcomes often look at lung function, exercise-related breathing measures, or the time until a first severe heart or COPD event.
- 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.
- Cardiopulmonary outcome studies track serious heart or COPD events over time in large groups of participants.
- Long-term COPD studies look at severe exacerbation rates in former smokers with COPD.
Other conditions studied
One Phase 3 study in congenital myopathy enrolled 20 participants and aimed to improve muscle strength and muscle function. The main outcome was the change in the MFM32 score after 6 months of treatment compared with no treatment.
Another Phase 3 trial studied hyperkalemia, which means high potassium in the blood, in emergency departments. This study compared nebulized Salbutamol, insulin/dextrose infusion, and the combination of both, and measured the change in serum potassium after 60 minutes.
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. Salbutamol appears in the intervention list for this study as part of the treatment setup.
One food allergy extension study also listed Salbutamol among its interventions, while its main purpose was long-term safety and tolerability of ligelizumab.
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. 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.
Participants range from young children to older adults, depending on the condition being studied. 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.
- Children are included in asthma studies that focus on lung function and safety.
- Adults are included in asthma, COPD, hyperkalemia, and chronic pulmonary aspergillosis studies.
- Former smokers and older adults are important groups in some COPD studies.
Endpoints measured
Trials use endpoints, which are the main results the researchers want to measure. In the Salbutamol trial data, endpoints include FEV1, MFM32, serum potassium change, annualized exacerbation rate, time to first event, and mucus scores.
- FEV1 is used in many asthma and COPD studies to measure lung function after treatment.
- MFM32 is used in congenital myopathy to measure muscle function over time.
- Serum potassium is used in hyperkalemia to see how quickly treatment lowers high potassium levels.
- Exacerbation rate measures how often serious disease flare-ups happen during the study period.
- Mucus score is used in one COPD study to assess airway mucus plugging on scans.
What Salbutamol means in these trials
In this trial set, Salbutamol is not always the main medicine being tested. 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.
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. The trial data show a broad research use across respiratory disease and a few non-respiratory conditions.