Salbutamol HFA-134a
Drug100 microgram (μg) (ex-valve) at 30-second intervals per actuation
NCT Number: NCT06261957
The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged >=18 years with asthma
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Notify Me18 year and older
All sexes
Interventional
Phase 3
GSK Investigational Site, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants should be able to withhold SABA for ≥6 hours and LABA-/ LAMA containing medications for ≥24 hours for the purposes of performing screening spirometry.
Exclusion criteria
100 microgram (μg) (ex-valve) at 30-second intervals per actuation
100 μg (ex-valve) at 30-second intervals per actuation
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
Time frame: Baseline (Day 1) and up to 3 months
ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma.
Time frame: Baseline (Day 1) and up to 3 months
GlaxoSmithKline
Industry
A Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Long-term Safety of Salbutamol Rescue Medication When Administered Via Metered Dose Inhalers Containing the Propellant HFA-152a or Reference HFA-134a
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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