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

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ClinicalTrials.gov Identifier: NCT02106000
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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


Condition or disease Intervention/treatment
Haemorrhage Device: Inhalation profile recorder

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 24, 2014
Actual Primary Completion Date : December 20, 2014
Actual Study Completion Date : December 20, 2014

Group/Cohort Intervention/treatment
Arm 1: Non-pregnant females
Inhalation profiles will be recorded for non-pregnant females
Device: Inhalation profile recorder
Up to three inhalation profiles will be recorded whilst inhaling with maximal effort

Arm 2: Pregnant females
Inhalation profiles will be recorded for the women in the 3rd stage of labour
Device: Inhalation profile recorder
Up to three inhalation profiles will be recorded whilst inhaling with maximal effort




Primary Outcome Measures :
  1. Characterization of the inhalation profile of non-pregnant women by measuring Peak pressure drop [ Time Frame: Screening, Up to Day 50 ]
    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

  2. Characterization of the inhalation profile of non-pregnant women by measuring Peak Inspiratory Flow Rate [ Time Frame: Screening, Up to Day 50 ]
    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

  3. Characterization of the inhalation profile of non-pregnant women by measuring Inhaled Volume [ Time Frame: Screening, Up to Day 50 ]
    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

  4. Characterization of the inhalation profile of non-pregnant women by measuring Inhalation time [ Time Frame: Screening, Up to Day 50 ]
    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)

  5. Characterization of the inhalation profile of non-pregnant women by measuring Average Inhalation Flow Rate [ Time Frame: Screening, Up to Day 50 ]
    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

  6. Characterization of the inhalation profile of non-pregnant women by measuring Acceleration rate [ Time Frame: Screening, Up to Day 50 ]
    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

  7. Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak pressure Drop [ Time Frame: Screening, Up to Day 50 ]
    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

  8. Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak Inspiratory Flow Rate [ Time Frame: Screening, Up to Day 50 ]
    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

  9. Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhaled Volume [ Time Frame: Screening, Up to Day 50 ]
    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

  10. Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhalation time [ Time Frame: Screening, Up to Day 50 ]
    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

  11. Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Average Inhalation Flow Rate [ Time Frame: Screening, Up to Day 50 ]
    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

  12. Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Acceleration rate [ Time Frame: Screening, Up to Day 50 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women: pregnant and non-pregnant non-pregnant female subject is eligible to participate in the study if she is in the age group of 18 to 30 years pregnant female will be eligible to participate in the study if she belongs to the age group of 18 to 30 years
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106000


Locations
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United Kingdom
GSK Investigational Site
Cambridge, United Kingdom, CB2 0SW
GSK Investigational Site
Cambridge, United Kingdom, CB2 2GG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02106000     History of Changes
Other Study ID Numbers: 201248
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Keywords provided by GlaxoSmithKline:
Post Partum
Inhaled Oxytocin
Inhalation Profiles
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes