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
Verified date | May 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | December 20, 2014 |
Est. primary completion date | December 20, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - A non-pregnant female subject is eligible to participate in the study if she is in the age group of 18 to 30 years (inclusive), at the time of signing the informed consent; is healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history; is having a body weight >= 50 kilogram (kg) and Body Mass Index (BMI) within the range 19 - 29.9 kg/meter^2 (inclusive); is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form; OR is having a clinical abnormality which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor, if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures - Pregnant Female will be eligible to participate in the study if she belongs to the age group of 18 to 30 years (inclusive), at the time of signing the informed consent; is healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history; is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form ;OR is having a clinical abnormality which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Exclusion Criteria: - Healthy Volunteers will be excluded from the study if they have a history or regular use of tobacco or smoking products within 6 months prior to screening; have a current history of Asthma or history of lung disease; have a history of Airway obstruction or abnormality OR have an upper or lower respiratory tract infection within four weeks of the inhalation assessment visit. - Pregnant Females will be excluded from the study if they are undergoing Caesarean Section; OR have preeclampsia; have an upper or lower respiratory tract infection within four weeks of the inhalation assessment visit; are receiving an epidural or opioid analgesia for pain management; OR require instrumental or otherwise assisted delivery as assessed by the midwife staff at time of inhalation assessment visit OR have a current history of asthma or lung disease ; have a history of airway obstruction or abnormality; OR have a history or regular use of tobacco or smoking products within 6 months prior to screening |
Country | Name | City | State |
---|---|---|---|
United Kingdom | GSK Investigational Site | Cambridge | |
United Kingdom | GSK Investigational Site | Cambridge |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterization of the inhalation profile of non-pregnant women by measuring Peak pressure drop | Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out by measuring the Peak pressure Drop (kPa) using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of non-pregnant women by measuring Peak Inspiratory Flow Rate | Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out for Peak Inspiratory Flow Rate [Liters/minute (L/min)] using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of non-pregnant women by measuring Inhaled Volume | Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out for the Inhaled Volume (L) using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of non-pregnant women by measuring Inhalation time | Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out for the Inhalation time measured in seconds(s) | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of non-pregnant women by measuring Average Inhalation Flow Rate | Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out for Average Inhalation Flow Rate (L/min) measured using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of non-pregnant women by measuring Acceleration rate | Up to three inhalation profiles will be recorded in the semi-supine position and the assessment of Acceleration rate (L/min/s) will be measured using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak pressure Drop | Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out by measuring the Peak pressure Drop (kPa) using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak Inspiratory Flow Rate | Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out for Peak Inspiratory Flow Rate (L/min) using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhaled Volume | Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out for the Inhaled Volume (L) using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhalation time | Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out for the Inhalation time measured in seconds | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Average Inhalation Flow Rate | Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out for Average Inhalation Flow Rate (L/min) measured using the inhalation profile recorder | Screening, Up to Day 50 | |
Primary | Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Acceleration rate | Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment of Acceleration rate (L/min/s) will be measured using the inhalation profile recorder | Screening, Up to Day 50 |
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