Haemorrhage Clinical Trial
Official title:
An Enabling Study to Compare the Inhalation Profiles of Women in the Third Stage of Labour to Those of Non-pregnant Female Volunteers and to Explore Whether There Are Any Differences Which Could Impact the Delivery of an Inhaled Medicinal Product
The purpose of this study is to record and compare the inhalation profiles of non pregnant
women and those who are in the third stage of labour. The inhalation profiles will be
recorded from consenting women as they inhale with maximal effort through an inhalation
profile recorder [Glaxosmithkline (GSK), Ware]. The recorder will simulate resistance to
airflow and will be representative of a dry powder inhaler of moderate resistivity. The
inhalation endpoints will include Peak Pressure Drop, Peak Inspiratory Flow Rate, Inhaled
Volume, Inhalation time, Average Inhalation Flow Rate and Acceleration rate which will be
compared between the two female cohorts. Inhalation profiles recorded in this way may
subsequently be used to study the in-vitro performance of investigational materials across
inhalation parameters representative of the target patient population.
An appropriate number of subjects will be consented so that approximately 40 subjects (20
non-pregnant females and 20 stage three labour subjects) complete assessments. The
inhalation profiles will be recorded on the same day of screening or at another time within
a span of 50 days
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