HaemorrhageNCT02106000
A Non-investigational Product (IP) Study to Investigate Lung Function in Women in the Third Stage of Labour
An observational study of Haemorrhage, run by GlaxoSmithKline at 2 sites in United Kingdom.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Haemorrhage
- What is being tested?
- Inhalation profile recorder
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 24 Jun 2014to 20 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
GSK Investigational Site
Cambridge, CB2 0SW
GSK Investigational Site
Cambridge, CB2 2GG
About this study
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
- Conditions
- Haemorrhage
- Being tested
- Inhalation profile recorder
- Keywords
- Post Partum, Inhaled Oxytocin, Inhalation Profiles
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation profile recorderDevice
Up to three inhalation profiles will be recorded whilst inhaling with maximal effort
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Non-pregnant females | Inhalation profiles will be recorded for non-pregnant females Receives: Device: Inhalation profile recorder | |
| Arm 2: Pregnant females | Inhalation profiles will be recorded for the women in the 3rd stage of labour Receives: Device: Inhalation profile recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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)
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
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
Measured: Screening, Up to Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study start24 Jun 2014
- Primary completion20 Dec 2014
- Study completion20 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhageStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106000
- Sponsor's protocol ID
- 201248
- Status last verified
- May 2017
- First submitted
- 3 Apr 2014
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02106000
- Acronym / sponsor ID
- 201248
- Conditions
- Haemorrhage
- Keywords
- Post Partum, Inhaled Oxytocin, Inhalation Profiles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2014 (actual)
- Primary completion
- 20 Dec 2014 (actual)
- Study completion
- 20 Dec 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Non-pregnant females | – | Device: Inhalation profile recorderInhalation profiles will be recorded for non-pregnant females |
| Arm 2: Pregnant females | – | Device: Inhalation profile recorderInhalation profiles will be recorded for the women in the 3rd stage of labour |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation profile recorderUp to three inhalation profiles will be recorded whilst inhaling with maximal effort | Device | Arm 1: Non-pregnant females, Arm 2: Pregnant females |
Primary outcome
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
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
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
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)
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Results for study 201248 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemorrhage, run by GlaxoSmithKline at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the inhalation profile of non-pregnant women by measuring Peak pressure drop (time frame: Screening, Up to Day 50). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.