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)
12. listopadu 2014 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Typ studie
Intervenční
Zápis (Aktuální)
449
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Brussel, Belgie, 1090
- Novartis Investigative Site
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Bruxelles, Belgie, 1070
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Genk, Belgie, 3600
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Gilly, Belgie, 6060
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Gosselies, Belgie, 6041
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Hasselt, Belgie, 3500
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Herentals, Belgie, 2200
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Jambes, Belgie, 5100
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Liège, Belgie, 4000
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Luxembourg, Belgie, 1210
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Malmedy/Bellevaux-Ligneuville, Belgie, 4960
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Montigny-le-tilleul, Belgie, 6110
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Turnhout, Belgie, 2300
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Yvoir, Belgie, 5530
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Pleven, Bulharsko, 5800
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Plovdiv, Bulharsko, 4002
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Ruse, Bulharsko, 7002
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Sofia, Bulharsko, 1431
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Sofia, Bulharsko, 1606
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Sofia, Bulharsko, 1000
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Stara Zagora, Bulharsko, 6000
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Varna, Bulharsko, 9010
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Cork
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Wilton, Cork, Irsko
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Ankara, Krocan, 06490
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Istanbul, Krocan, 34854
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Istanbul, Krocan
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Kocaeli, Krocan, 41380
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Mersin, Krocan, 33079
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Yenisehir/Izmir, Krocan, 35110
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Budapest, Maďarsko, 1121
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Budapest, Maďarsko, 1046
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Deszk, Maďarsko, 6772
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Erd, Maďarsko, H-2030
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Godollo, Maďarsko, 2100
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Moscow, Ruská Federace, 125315
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N.Novgorod, Ruská Federace, 603126
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Nizhny Novgorod, Ruská Federace, 603018
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Saratov, Ruská Federace, 410012
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Bratislava, Slovensko, 826 06
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Kosice, Slovensko, 040 01
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Kralovsky Chlmec, Slovensko, 077 01
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Slovak Republic
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Bardejov, Slovak Republic, Slovensko, 085 01
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Bojnice, Slovak Republic, Slovensko, 972 01
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Liptovsky Hradok, Slovak Republic, Slovensko, 033 01
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Slovensko
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Námestovo, Slovensko, Slovensko, 02901
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Bath, Spojené království, BA1 2SR
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Bexhill-on-Sea, Spojené království, TN40 1JJ
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Blackpool, Spojené království, FY3 7EN
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Bradford, Spojené království, BD9 6RJ
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Cambridge, Spojené království, CB7 5JD
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Chesterfield, Spojené království, S40 4AA
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Huntingdon, Spojené království, PE29 6NT
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Manchester, Spojené království, M20 2RN
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Newcastle-upon-Tyne, Spojené království, NE7 7DN
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Newton Aycliffe, Spojené království, DL5 4SE
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Reading, Spojené království, RG7 3SQ
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Southbourne, Spojené království
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Telford, Spojené království, TF1 6TF
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Watford, Spojené království, WD25 0EA
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Wiltshire, Spojené království, SN15 2SB
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County Durham
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Burnhope, County Durham, Spojené království, DH7 0BD
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Suffolk
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Alderton, Suffolk, Spojené království, IP12 3DA
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Warwickshire
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Atherstone, Warwickshire, Spojené království, CV9 1EU
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Leamington Spa, Warwickshire, Spojené království, CV32 4RA
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Yorkshire
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Strensall, Yorkshire, Spojené království, YO32 5UA
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Athens, Řecko, 11527
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GR
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Athens, GR, Řecko, 115 27
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Athens, GR, Řecko, 106 76
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Thessaloniki, GR, Řecko, 564 03
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Barcelona, Španělsko, 08025
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Andalucia
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Malaga, Andalucia, Španělsko, 29010
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Asturias
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Gijon, Asturias, Španělsko, 33290
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Cantabria
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Torrelavega, Cantabria, Španělsko, 39300
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Castilla la Mancha
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Illescas, Castilla la Mancha, Španělsko, 45200
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Castilla y Leon
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Ponferrada, Castilla y Leon, Španělsko, 24400
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Cataluña
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Centelles, Cataluña, Španělsko, 08540
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Salt, Cataluña, Španělsko, 17190
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Sant Boi de Llobregat, Cataluña, Španělsko, 08830
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Viladecans, Cataluña, Španělsko
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Extremadura
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Mérida, Extremadura, Španělsko, 06800
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: NVA237 + indacaterol
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NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Ostatní jména:
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Komparátor placeba: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Trough Forced Expiratory Volume at 1 Second (FEV1)
Časové okno: 12 weeks
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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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.
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12 weeks
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FEV1 at Individual Time-points
Časové okno: Day 1, Day 29, Day 57 and Days 84/85
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: baseline, 12 weeks
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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.
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baseline, 12 weeks
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Change From Baseline in Mean Daily Total and Individual Symptom Scores
Časové okno: Baseline, 12 weeks
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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).
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Baseline, 12 weeks
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Number of Participants With Adverse Events and Serious Adverse Events
Časové okno: 12 weeks
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All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.
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12 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. května 2012
Primární dokončení (Aktuální)
1. ledna 2013
Dokončení studie (Aktuální)
1. ledna 2013
Termíny zápisu do studia
První předloženo
21. května 2012
První předloženo, které splnilo kritéria kontroly kvality
21. května 2012
První zveřejněno (Odhad)
23. května 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
14. listopadu 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. listopadu 2014
Naposledy ověřeno
1. listopadu 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Plicní onemocnění
- Plicní onemocnění, obstrukční
- Plicní onemocnění, chronická obstrukční
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Muskarinoví antagonisté
- Cholinergní antagonisté
- Cholinergní činidla
- Adjuvans, anestezie
- Antikonvulziva
- Glykopyrolát
- Bromidy
Další identifikační čísla studie
- CNVA237A2316
- 2011-005673-23 (Číslo EudraCT)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na NVA237 50 µg and indacaterol 150 µg
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Novartis PharmaceuticalsDokončenoChronická obstrukční plicní nemocSpojené státy, Německo, Maďarsko, Belgie, Polsko, Španělsko, Holandsko
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Statens Serum InstitutDokončeno
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University of OxfordInstitut de Recherche en Sciences de la Sante, Burkina FasoNábor
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Butantan InstituteInCor - Instituto do Coração - HCFMUSP.Staženo
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Berlin-Chemie AG Menarini GroupDokončeno
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University of UlsterUniversity of Bergen; University of Dublin, Trinity CollegeDokončeno
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Orion Corporation, Orion PharmaDokončeno