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

2017年5月23日 更新者: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

調査の概要

状態

完了

条件

研究の種類

観察的

入学 (実際)

40

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Cambridge、イギリス、CB2 2GG
        • GSK Investigational Site
      • Cambridge、イギリス、CB2 0SW
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~30年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Characterization of the inhalation profile of non-pregnant women by measuring Peak pressure drop
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年6月24日

一次修了 (実際)

2014年12月20日

研究の完了 (実際)

2014年12月20日

試験登録日

最初に提出

2014年4月3日

QC基準を満たした最初の提出物

2014年4月3日

最初の投稿 (見積もり)

2014年4月7日

学習記録の更新

投稿された最後の更新 (実際)

2017年5月25日

QC基準を満たした最後の更新が送信されました

2017年5月23日

最終確認日

2017年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 201248

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