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

23 de mayo de 2017 actualizado por: GlaxoSmithKline

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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

40

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Cambridge, Reino Unido, CB2 2GG
        • GSK Investigational Site
      • Cambridge, Reino Unido, CB2 0SW
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 30 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Arm 1: Non-pregnant females
Inhalation profiles will be recorded for non-pregnant females
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
Up to three inhalation profiles will be recorded whilst inhaling with maximal effort

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Characterization of the inhalation profile of non-pregnant women by measuring Peak pressure drop
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of non-pregnant women by measuring Peak Inspiratory Flow Rate
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of non-pregnant women by measuring Inhaled Volume
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of non-pregnant women by measuring Inhalation time
Periodo de tiempo: 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)
Screening, Up to Day 50
Characterization of the inhalation profile of non-pregnant women by measuring Average Inhalation Flow Rate
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of non-pregnant women by measuring Acceleration rate
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak pressure Drop
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak Inspiratory Flow Rate
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhaled Volume
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhalation time
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Average Inhalation Flow Rate
Periodo de tiempo: 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
Screening, Up to Day 50
Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Acceleration rate
Periodo de tiempo: 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
Screening, Up to Day 50

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de junio de 2014

Finalización primaria (Actual)

20 de diciembre de 2014

Finalización del estudio (Actual)

20 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

3 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

3 de abril de 2014

Publicado por primera vez (Estimar)

7 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de mayo de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

23 de mayo de 2017

Última verificación

1 de mayo de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 201248

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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