Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
2017年10月9日 更新者：GlaxoSmithKline
A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids
The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
348
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
-
-
California
-
Huntington Beach、California、アメリカ、92647
- GSK Investigational Site
-
-
Florida
-
Orlando、Florida、アメリカ、32822
- GSK Investigational Site
-
Tallahassee、Florida、アメリカ、32308
- GSK Investigational Site
-
-
Georgia
-
Lawrenceville、Georgia、アメリカ、30046
- GSK Investigational Site
-
-
New Jersey
-
Skillman、New Jersey、アメリカ、08558
- GSK Investigational Site
-
-
North Carolina
-
Raleigh、North Carolina、アメリカ、27607
- GSK Investigational Site
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45231
- GSK Investigational Site
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73103
- GSK Investigational Site
-
-
South Carolina
-
Chester、South Carolina、アメリカ、29706
- GSK Investigational Site
-
Clinton、South Carolina、アメリカ、29325
- GSK Investigational Site
-
Orangeburg、South Carolina、アメリカ、29118
- GSK Investigational Site
-
-
-
-
-
Dnipropetrovsk、ウクライナ、49074
- GSK Investigational Site
-
Dnipropetrovsk、ウクライナ、49027
- GSK Investigational Site
-
Donetsk、ウクライナ、83099
- GSK Investigational Site
-
Ivano-Frankivsk、ウクライナ、76018
- GSK Investigational Site
-
Kharkiv、ウクライナ、61124
- GSK Investigational Site
-
Kharkiv、ウクライナ、61037
- GSK Investigational Site
-
Kyiv、ウクライナ、03680
- GSK Investigational Site
-
Simferopol、ウクライナ、95043
- GSK Investigational Site
-
Yalta、ウクライナ、98603
- GSK Investigational Site
-
-
-
-
Bayern
-
Gauting、Bayern、ドイツ、82131
- GSK Investigational Site
-
-
Hessen
-
Frankfurt、Hessen、ドイツ、60596
- GSK Investigational Site
-
-
Rheinland-Pfalz
-
Mainz、Rheinland-Pfalz、ドイツ、55131
- GSK Investigational Site
-
-
Schleswig-Holstein
-
Grosshansdorf、Schleswig-Holstein、ドイツ、22927
- GSK Investigational Site
-
-
-
-
-
Lima、ペルー、Lima 27
- GSK Investigational Site
-
-
Lima
-
Callao、Lima、ペルー、Callao 2
- GSK Investigational Site
-
Lima 27、Lima、ペルー、Lima 27
- GSK Investigational Site
-
San Isidro、Lima、ペルー、Lima 27
- GSK Investigational Site
-
San Miguel、Lima、ペルー、Lima 32
- GSK Investigational Site
-
-
-
-
-
Chrzanow、ポーランド、32-500
- GSK Investigational Site
-
Krakow、ポーランド、31-024
- GSK Investigational Site
-
Krakow、ポーランド、31-455
- GSK Investigational Site
-
Krakow、ポーランド、30-901
- GSK Investigational Site
-
Lublin、ポーランド、20-552
- 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:
- Outpatient at least 12 years of age
- Both genders; females of childbearing potential must be willing to use birth control method
- Clinical diagnosis of asthma for ≥12 weeks
- Best pre-bronchodilator FEV1 of 40%-90% predicted
- Reversibility of FEV1 of at least 12% and 200mls
- Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
- Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits
Exclusion Criteria:
- History of life-threatening asthma
- Respiratory infection within last 4 weeks leading to change in asthma management
- Asthma exacerbation within last 3 months
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, or medications related to study drugs
- Taking another investigational medication or medication prohibited for use during the study.
- Previous participation in a vilanterol (GW642444) study
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Vilanterol
Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
|
Vilanterol inhalation powder inhaled orally once daily for 12 weeks
Placebo inhalation powder inhaled orally twice daily for 12 weeks
|
|
アクティブコンパレータ：Salmeterol
Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
|
Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
|
|
プラセボコンパレーター：Placebo
Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
|
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via 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 Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
時間枠：Baseline and Week 12
|
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second.
The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12.
The Baseline value was the Day 1 pre-dose FEV1 measurement.
Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value.
Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
|
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 During the 12-week Treatment Period
時間枠：Baseline and Weeks 1-12
|
The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period.
The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization).
Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
|
Baseline and Weeks 1-12
|
|
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
時間枠：Baseline and Weeks 1-12
|
Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed.
The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization).
Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
|
Baseline and Weeks 1-12
|
|
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
時間枠：Baseline and Week 12
|
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second.
The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12).
The Baseline value was the Day 1 pre-dose FEV1 measurement.
Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value.
Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.
Analysis was performed separately for each planned time point.
|
Baseline and Week 12
|
|
Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
時間枠：Baseline and Weeks 1-12
|
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug.
The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization.
Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
|
Baseline and Weeks 1-12
|
|
Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
時間枠：Baseline and Weeks 1-12
|
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug.
The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization.
Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
|
Baseline and Weeks 1-12
|
|
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
時間枠：Day 1 and Week 12
|
The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points.
Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.
|
Day 1 and Week 12
|
|
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
時間枠：Week 4 and Week 12
|
At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.
|
Week 4 and Week 12
|
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
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。
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
2010年9月1日
一次修了 (実際)
2011年8月1日
研究の完了 (実際)
2011年8月26日
試験登録日
最初に提出
2010年7月15日
QC基準を満たした最初の提出物
2010年8月12日
最初の投稿 (見積もり)
2010年8月13日
学習記録の更新
投稿された最後の更新 (実際)
2017年11月8日
QC基準を満たした最後の更新が送信されました
2017年10月9日
最終確認日
2017年10月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 112060
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
-
臨床研究報告書
情報識別子：112060情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
注釈付き症例報告書
情報識別子：112060情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
インフォームド コンセント フォーム
情報識別子：112060情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
統計分析計画
情報識別子：112060情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
個人参加者データセット
情報識別子：112060情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
研究プロトコル
情報識別子：112060情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
データセット仕様
情報識別子：112060情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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。