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The primary objective of this study was to assess the effect of multiple doses of the HFA-152a propellant and the HFA-134a propellant on mucociliary clearance (MCC).
Full description
This clinical trial was a Phase I, single-centre, multiple-dose, randomised, open-label, controlled, 2-way cross-over study to assess the effect on MCC of the new HFA-152a propellant (5 inhalations BID for 8 days) versus the marketed HFA-134a propellant (5 inhalations BID for 8 days) in adult healthy volunteers by measuring the clearance from the lungs of inhaled radioaerosol.
A total of 20 subjects were randomised into the study.
Standard safety assessments was conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs, spirometry, and observations of any adverse events (AE).
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Interventional model
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20 participants in 2 patient groups, including a placebo group
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Chiesi Clinical Trial Info
Data sourced from clinicaltrials.gov
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