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Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma

2016年11月20日 更新者：GlaxoSmithKline

A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Not Currently Receiving Inhaled Corticosteroids

A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).

研究の種類

介入

入学 (実際)

248

段階

  • フェーズ 3

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

  • アメリカ
    • California
      • Long Beach、California、アメリカ、90808
        • GSK Investigational Site
      • Los Angeles、California、アメリカ、90025
        • GSK Investigational Site
      • Newport Beach、California、アメリカ、92663
        • GSK Investigational Site
    • Georgia
      • Albany、Georgia、アメリカ、31707
        • GSK Investigational Site
    • Missouri
      • Columbia、Missouri、アメリカ、65203
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73103
        • GSK Investigational Site
    • South Carolina
      • Orangeburg、South Carolina、アメリカ、29118
        • GSK Investigational Site
      • Spartanburg、South Carolina、アメリカ、29303
        • GSK Investigational Site
    • Texas
      • Corsicana、Texas、アメリカ、75110
        • GSK Investigational Site
      • Waco、Texas、アメリカ、76712
        • GSK Investigational Site
  • ペルー
      • Lima、ペルー、Lima 1
        • GSK Investigational Site
      • Lima、ペルー、Lima 27
        • GSK Investigational Site
    • Lima
      • Lima 18、Lima、ペルー
        • GSK Investigational Site
      • San Borja、Lima、ペルー、Lima 41
        • GSK Investigational Site
      • San Miguel、Lima、ペルー、Lima 32
        • GSK Investigational Site
  • メキシコ
    • Jalisco
      • Zapopan、Jalisco、メキシコ、45040
        • GSK Investigational Site
    • Michoacán
      • Morelia、Michoacán、メキシコ、58070
        • GSK Investigational Site
    • Tabasco
      • Villahermosa、Tabasco、メキシコ、86100
        • GSK Investigational Site
  • ロシア連邦
      • Klin、ロシア連邦、141600
        • GSK Investigational Site
      • Moscow、ロシア連邦、115446
        • GSK Investigational Site
      • Saratov、ロシア連邦、410028
        • GSK Investigational Site
      • St. Petersburg、ロシア連邦、194356
        • GSK Investigational Site
      • Voronezh、ロシア連邦、394066
        • GSK Investigational Site
      • Yaroslavl、ロシア連邦、150003
        • 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

12年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Signed informed consent
  • Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before first visit
  • Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
  • Pre-bronchodilator FEV1 of at least 60% predicted
  • FEV1 reversibility of at least 12% and 200mls
  • Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist

Exclusion Criteria:

  • History of life-threatening asthma exacerbation within the past 10 years
  • Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
  • Current or recent respiratory infection or current oral candida infection
  • Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
  • Known or suspected allergy to study drug or materials
  • Taking another investigational medication or prohibited medication during the study
  • Previous treatment with inhaled fluticasone furoate in a phase II or III study
  • Current smokers or former smokers with significant tobacco exposure
  • Children in Care

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

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Fluticasone furoate 50mcg
Inhalation powder delivered by Novel Dry Powder Inhaler
薬：Fluticasone furoate 50mcg
Inhalation powder delivered by Novel Dry Powder Inhaler
プラセボコンパレーター：Placebo
Inhalation powder delivered by Novel Dry Powder Inhaler
薬：Placebo
Inhalation powder delivered by Novel Dry Powder Inhaler

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
Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period
時間枠：Baseline and Week 12
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 12 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.
Baseline and Week 12

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period
時間枠：From Baseline up to Week 12
The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 12
Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
時間枠：From Baseline up to Week 12
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 12
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period
時間枠：From Baseline up to Week 12
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 12
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period
時間枠：From Baseline up to Week 12
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 12
Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period
時間枠：From the first dose of the study medication until Week 12/Early Withdrawal
The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.
From the first dose of the study medication until Week 12/Early Withdrawal

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。

スポンサー

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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

2011年9月1日

一次修了 (実際)

2012年6月1日

研究の完了 (実際)

2012年8月1日

試験登録日

最初に提出

2011年9月15日

QC基準を満たした最初の提出物

2011年9月15日

最初の投稿 (見積もり)

2011年9月19日

学習記録の更新

投稿された最後の更新 (見積もり)

2017年1月11日

QC基準を満たした最後の更新が送信されました

2016年11月20日

最終確認日

2016年11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

  • 115283

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. 統計分析計画
    情報識別子：115283
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. データセット仕様
    情報識別子：115283
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 研究プロトコル
    情報識別子：115283
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 臨床研究報告書
    情報識別子：115283
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. インフォームド コンセント フォーム
    情報識別子：115283
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 個人参加者データセット
    情報識別子：115283
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. 注釈付き症例報告書
    情報識別子：115283
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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