Table of Contents

• Trial overview
• Conditions studied
• Trial phases and status
• Main endpoints and what they mean
• Who participates in these trials
• Study designs and comparators
• Patient-focused summary

Trial overview

These studies investigate Salbutamol Sulfate in different clinical settings, mostly as part of larger interventional trials.^[1] The trial data show research in asthma, COPD, bronchiectasis, newborn breathing disorders, hyperkalemia, and ALS.^[1]

Conditions studied

Asthma is one of the main conditions studied, including adult asthma, severe eosinophilic asthma, T2-high asthma, and asthma in children with episodic wheezing.^{[4][5][6][7][8][12][14]} COPD is another major area, including symptomatic COPD, COPD with a history of exacerbations, acute exacerbation of COPD, and COPD with type 2 inflammation.^{[2][3][9][13][15]} Other trials study bronchiectasis, cystic fibrosis bronchiectasis, neonatal respiratory failure linked to pulmonary hypertension, hyperkalemia, and ALS.^{[1][10][11][12]}

Trial phases and status

Most of the trials are Phase 2 or Phase 3, which means they are testing how well the study approach works and how safe it is in larger groups of people.^[1] One study is listed as Phase 1 and focuses on safety and tolerability in non-cystic fibrosis bronchiectasis.^[10] Some studies are completed, some are authorised, one is ongoing, and several were withdrawn before completion.^[1]

Main endpoints and what they mean

Several trials measure treatment-emergent adverse events, which are health problems that begin or worsen after treatment starts.^[1][10] Lung studies often use FEV1, a test of how much air a person can blow out in one second, and some use FEV1 over time after treatment.^[4][5][6] Other endpoints include annualized exacerbation rates, 30-day mortality, serum potassium change at 60 minutes, symptom control, and the 6-minute walking test.^{[2][3][8][11][12][13][15]}

Who participates in these trials

Participants include adults with asthma or COPD, children aged 1 to 6 years with episodic wheezing, adolescents and adults with severe eosinophilic asthma, newborns with breathing disorders, and ambulatory ALS patients.^{[4][5][6][7][8][11][12]} Some studies also focus on former smokers with COPD.^[2][3]

Study designs and comparators

Most trials are interventional, meaning the researchers assign treatments and compare outcomes between groups.^[1] Several studies compare Salbutamol Sulfate with placebo, while others compare it with active treatments or use it as part of standard care.^{[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]} In some studies, Salbutamol Sulfate is used together with another treatment, so the study is really testing the full treatment plan rather than Salbutamol Sulfate alone.^{[2][3][4][5][6][7][8][9][10][11][12][13][14][15]}

Patient-focused summary

For patients, the main point is that Salbutamol Sulfate is being studied in many different groups, not just one disease.^[1] The research is looking at both safety and how well the treatment plan works in real clinical situations.^[1] The outcomes are practical ones that matter to patients, such as breathing ability, flare-ups, emergency events, daily function, and short-term survival in some settings.^{[2][3][8][11][12]}