NCT02106000

A Non-investigational Product (IP) Study to Investigate Lung Function in Women in the Third Stage of Labour

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Haemorrhage

Interventions

Type	Name	Description
DEVICE	Inhalation profile recorder	Up to three inhalation profiles will be recorded whilst inhaling with maximal effort

Timeline

• Start date: 2014-06-24
• Primary completion: 2014-12-20
• Completion: 2014-12-20
• First posted: 2014-04-07
• Last updated: 2017-05-25

Locations

2 sites across 1 country: United Kingdom