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

23 de maio de 2017 atualizado 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

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

40

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 30 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Characterization of the inhalation profile of non-pregnant women by measuring Peak pressure drop
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

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Datas Principais do Estudo

Início do estudo (Real)

24 de junho de 2014

Conclusão Primária (Real)

20 de dezembro de 2014

Conclusão do estudo (Real)

20 de dezembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

3 de abril de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de abril de 2014

Primeira postagem (Estimativa)

7 de abril de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de maio de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de maio de 2017

Última verificação

1 de maio de 2017

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 201248

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