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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Non-pregnant females | Inhalation profiles will be recorded for non-pregnant females |
| |
| Arm 2: Pregnant females | Inhalation profiles will be recorded for the women in the 3rd stage of labour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalation profile recorder | Device | Up to three inhalation profiles will be recorded whilst inhaling with maximal effort |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | CB2 0SW | United Kingdom | |||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study 201248 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Cambridge |
| CB2 2GG |
| United Kingdom |