Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (GLOW6)
2014年11月12日 更新者：Novartis Pharmaceuticals
A 12-week Multi-center, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of the Co-administration of NVA237 + Indacaterol Once Daily vs. Indacaterol Once Daily in Patients With Moderate to Severe COPD
This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
449
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
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Cork
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Wilton、Cork、アイルランド
- Novartis Investigative Site
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Bath、イギリス、BA1 2SR
- Novartis Investigative Site
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Bexhill-on-Sea、イギリス、TN40 1JJ
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Blackpool、イギリス、FY3 7EN
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Bradford、イギリス、BD9 6RJ
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Cambridge、イギリス、CB7 5JD
- Novartis Investigative Site
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Chesterfield、イギリス、S40 4AA
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Huntingdon、イギリス、PE29 6NT
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Manchester、イギリス、M20 2RN
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Newcastle-upon-Tyne、イギリス、NE7 7DN
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Newton Aycliffe、イギリス、DL5 4SE
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Reading、イギリス、RG7 3SQ
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Southbourne、イギリス
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Telford、イギリス、TF1 6TF
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Watford、イギリス、WD25 0EA
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Wiltshire、イギリス、SN15 2SB
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County Durham
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Burnhope、County Durham、イギリス、DH7 0BD
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Suffolk
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Alderton、Suffolk、イギリス、IP12 3DA
- Novartis Investigative Site
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Warwickshire
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Atherstone、Warwickshire、イギリス、CV9 1EU
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Leamington Spa、Warwickshire、イギリス、CV32 4RA
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Yorkshire
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Strensall、Yorkshire、イギリス、YO32 5UA
- Novartis Investigative Site
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Athens、ギリシャ、11527
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GR
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Athens、GR、ギリシャ、115 27
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Athens、GR、ギリシャ、106 76
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Thessaloniki、GR、ギリシャ、564 03
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Barcelona、スペイン、08025
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Andalucia
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Malaga、Andalucia、スペイン、29010
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Asturias
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Gijon、Asturias、スペイン、33290
- Novartis Investigative Site
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Cantabria
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Torrelavega、Cantabria、スペイン、39300
- Novartis Investigative Site
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Castilla la Mancha
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Illescas、Castilla la Mancha、スペイン、45200
- Novartis Investigative Site
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Castilla y Leon
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Ponferrada、Castilla y Leon、スペイン、24400
- Novartis Investigative Site
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Cataluña
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Centelles、Cataluña、スペイン、08540
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Salt、Cataluña、スペイン、17190
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Sant Boi de Llobregat、Cataluña、スペイン、08830
- Novartis Investigative Site
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Viladecans、Cataluña、スペイン
- Novartis Investigative Site
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Extremadura
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Mérida、Extremadura、スペイン、06800
- Novartis Investigative Site
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Bratislava、スロバキア、826 06
- Novartis Investigative Site
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Kosice、スロバキア、040 01
- Novartis Investigative Site
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Kralovsky Chlmec、スロバキア、077 01
- Novartis Investigative Site
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Slovak Republic
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Bardejov、Slovak Republic、スロバキア、085 01
- Novartis Investigative Site
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Bojnice、Slovak Republic、スロバキア、972 01
- Novartis Investigative Site
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Liptovsky Hradok、Slovak Republic、スロバキア、033 01
- Novartis Investigative Site
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Slovensko
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Námestovo、Slovensko、スロバキア、02901
- Novartis Investigative Site
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Budapest、ハンガリー、1121
- Novartis Investigative Site
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Budapest、ハンガリー、1046
- Novartis Investigative Site
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Deszk、ハンガリー、6772
- Novartis Investigative Site
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Erd、ハンガリー、H-2030
- Novartis Investigative Site
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Godollo、ハンガリー、2100
- Novartis Investigative Site
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Pleven、ブルガリア、5800
- Novartis Investigative Site
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Plovdiv、ブルガリア、4002
- Novartis Investigative Site
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Ruse、ブルガリア、7002
- Novartis Investigative Site
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Sofia、ブルガリア、1431
- Novartis Investigative Site
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Sofia、ブルガリア、1606
- Novartis Investigative Site
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Sofia、ブルガリア、1000
- Novartis Investigative Site
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Stara Zagora、ブルガリア、6000
- Novartis Investigative Site
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Varna、ブルガリア、9010
- Novartis Investigative Site
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Brussel、ベルギー、1090
- Novartis Investigative Site
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Bruxelles、ベルギー、1070
- Novartis Investigative Site
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Genk、ベルギー、3600
- Novartis Investigative Site
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Gilly、ベルギー、6060
- Novartis Investigative Site
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Gosselies、ベルギー、6041
- Novartis Investigative Site
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Hasselt、ベルギー、3500
- Novartis Investigative Site
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Herentals、ベルギー、2200
- Novartis Investigative Site
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Jambes、ベルギー、5100
- Novartis Investigative Site
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Liège、ベルギー、4000
- Novartis Investigative Site
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Luxembourg、ベルギー、1210
- Novartis Investigative Site
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Malmedy/Bellevaux-Ligneuville、ベルギー、4960
- Novartis Investigative Site
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Montigny-le-tilleul、ベルギー、6110
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Turnhout、ベルギー、2300
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Yvoir、ベルギー、5530
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Moscow、ロシア連邦、125315
- Novartis Investigative Site
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N.Novgorod、ロシア連邦、603126
- Novartis Investigative Site
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Nizhny Novgorod、ロシア連邦、603018
- Novartis Investigative Site
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Saratov、ロシア連邦、410012
- Novartis Investigative Site
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Ankara、七面鳥、06490
- Novartis Investigative Site
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Istanbul、七面鳥、34854
- Novartis Investigative Site
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Istanbul、七面鳥
- Novartis Investigative Site
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Kocaeli、七面鳥、41380
- Novartis Investigative Site
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Mersin、七面鳥、33079
- Novartis Investigative Site
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Yenisehir/Izmir、七面鳥、35110
- Novartis Investigative Site
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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
40年歳以上 (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:
- Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
- Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
- Current or ex-smokers who have a smoking history of at least 10 pack years
- Symptomatic patients according to daily diary data.
Exclusion Criteria:
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless using adequate contraception.
- Patients with Type I or uncontrolled Type II diabetes.
- Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
- Patients with paroxysmal (e.g. intermittent) atrial fibrillation
- Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)
Other protocol-defined inclusion/exclusion criteria may apply.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：NVA237 + indacaterol
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NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
他の名前：
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プラセボコンパレーター：Placebo to NVA237 + indacaterol
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Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.
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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 |
|---|---|---|
|
Trough Forced Expiratory Volume at 1 Second (FEV1)
時間枠：12 weeks
|
Centralized spirometry according to internationally accepted standards was used.
The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect.
If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward.
These measurements had to have been taken before the next dose of study medication.
FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
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12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
時間枠：12 weeks
|
Centralized spirometry was used according to internationally accepted standards was used.
The trapezoidal rule was applied to calculate FEV1 Area Under the Curve (AUC) and then normalized to the length of time.
Whether the participants had complete or incomplete FEV1 assessments in respective time ranges, their AUCs were calculated based on the existing FEV1 measurements (i.e., the missing FEV1 measurements were not interpolated).
Specifically, for those participants who had a FEV1 assessment at only one time-point, their AUC was approximated by the observed FEV1.
FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
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12 weeks
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Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks
時間枠：12 weeks
|
Centralized spirometry was used according to internationally accepted standards was used.
Peak FEV1 was defined as the maximum FEV1 during the first 4 hours post morning dosing.
The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in a region as a random effect.
If all FEV1 measurements were missing from 30 minutes onward, the peak FEV1 was not calculated.
FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
|
12 weeks
|
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FEV1 at Individual Time-points
時間枠：Day 1, Day 29, Day 57 and Days 84/85
|
Centralized spirometry according to internationally accepted standards was used.
FEV1 was measured at all post-dose time points up to 4 hours, and at 23 hours 15 minutes and 23 hours 45 minutes, by visit.
The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect.
FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
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Day 1, Day 29, Day 57 and Days 84/85
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Forced Vital Capacity (FVC) at Individual Time-points
時間枠：Day 1, Day 29, Day 57 and Days 84/85
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FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 minutes and 23 hours 45 minutes, by visit.
The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FVC, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect.
FVC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.
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Day 1, Day 29, Day 57 and Days 84/85
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Inspiratory Capacity (IC) at Individual Time-points
時間枠：Day 1, Days 84/85
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Inspiratory Capacity (IC) was measured at 20 min pre-dose and at post-dose at 25 minutes, 1 hour 55 minutes, 3 hours 55 minutes and 23 hours 40 minutes, by visit.
The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of IC, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect.
IC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.
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Day 1, Days 84/85
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Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
時間枠：Baseline, 12 weeks
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The number of puffs of rescue medication taken in the previous 12 hours was recorded in the patient diary in the morning and evening.
The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient.
If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator.
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Baseline, 12 weeks
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Transitional Dyspnea Index (TDI) Focal Score
時間枠：baseline, 12 weeks
|
Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during treatment using the Transitional Dyspnea Index (TDI).
Analysis was done via mixed model.
The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort.
BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity.
TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration.
A TDI focal score of 1 is considered a minimal clinically important difference.
|
baseline, 12 weeks
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Change From Baseline in Mean Daily Total and Individual Symptom Scores
時間枠：Baseline, 12 weeks
|
The symptoms (respiratory, cough, wheeze, sputum color, sputum production, breathlessness, sore throat, nasal discharge or congestion, and fever) for the whole active treatment period was analyzed using a mixed model, which contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline symptom score, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect.
Each symptom was scored as 0, 1, 2 or 3 where the description for each score varied.
For each of the symptoms, the range of scores from 0 to 3 represented an increase in symptoms where 0 represented little to no symptom and 3 represented severe or worst symptom.
The total symptom score, which is the sum of the individual scores, ranged from 0 (best possible outcome) to 27 (worst possible outcome).
|
Baseline, 12 weeks
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Number of Participants With Adverse Events and Serious Adverse Events
時間枠：12 weeks
|
All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.
|
12 weeks
|
協力者と研究者
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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
2012年5月1日
一次修了 (実際)
2013年1月1日
研究の完了 (実際)
2013年1月1日
試験登録日
最初に提出
2012年5月21日
QC基準を満たした最初の提出物
2012年5月21日
最初の投稿 (見積もり)
2012年5月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年11月14日
QC基準を満たした最後の更新が送信されました
2014年11月12日
最終確認日
2014年11月1日
詳しくは
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。
NVA237 50 µg and indacaterol 150 µgの臨床試験
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Novartis Pharmaceuticals完了
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BlueWillow BiologicsPorton Biopharma Ltd.完了
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University of MiamiADC Therapeutics S.A.募集
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GlaxoSmithKline完了
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Institut National de la Santé Et de la Recherche...EVI Industries, Inc.; BPRC; Recherche Clinique Paris Descartes Necker Cochin Sainte Anne; Centre...完了