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 november 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
449
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Brussel, België, 1090
- Novartis Investigative Site
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Bruxelles, België, 1070
- Novartis Investigative Site
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Genk, België, 3600
- Novartis Investigative Site
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Gilly, België, 6060
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Gosselies, België, 6041
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Hasselt, België, 3500
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Herentals, België, 2200
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Jambes, België, 5100
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Liège, België, 4000
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Luxembourg, België, 1210
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Malmedy/Bellevaux-Ligneuville, België, 4960
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Montigny-le-tilleul, België, 6110
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Turnhout, België, 2300
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Yvoir, België, 5530
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Pleven, Bulgarije, 5800
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Plovdiv, Bulgarije, 4002
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Ruse, Bulgarije, 7002
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Sofia, Bulgarije, 1431
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Sofia, Bulgarije, 1606
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Sofia, Bulgarije, 1000
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Stara Zagora, Bulgarije, 6000
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Varna, Bulgarije, 9010
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Athens, Griekenland, 11527
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GR
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Athens, GR, Griekenland, 115 27
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Athens, GR, Griekenland, 106 76
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Thessaloniki, GR, Griekenland, 564 03
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Budapest, Hongarije, 1121
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Budapest, Hongarije, 1046
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Deszk, Hongarije, 6772
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Erd, Hongarije, H-2030
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Godollo, Hongarije, 2100
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Cork
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Wilton, Cork, Ierland
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Ankara, Kalkoen, 06490
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Istanbul, Kalkoen, 34854
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Istanbul, Kalkoen
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Kocaeli, Kalkoen, 41380
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Mersin, Kalkoen, 33079
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Yenisehir/Izmir, Kalkoen, 35110
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Moscow, Russische Federatie, 125315
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N.Novgorod, Russische Federatie, 603126
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Nizhny Novgorod, Russische Federatie, 603018
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Saratov, Russische Federatie, 410012
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Bratislava, Slowakije, 826 06
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Kosice, Slowakije, 040 01
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Kralovsky Chlmec, Slowakije, 077 01
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Slovak Republic
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Bardejov, Slovak Republic, Slowakije, 085 01
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Bojnice, Slovak Republic, Slowakije, 972 01
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Liptovsky Hradok, Slovak Republic, Slowakije, 033 01
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Slovensko
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Námestovo, Slovensko, Slowakije, 02901
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Barcelona, Spanje, 08025
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Andalucia
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Malaga, Andalucia, Spanje, 29010
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Asturias
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Gijon, Asturias, Spanje, 33290
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Cantabria
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Torrelavega, Cantabria, Spanje, 39300
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Castilla la Mancha
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Illescas, Castilla la Mancha, Spanje, 45200
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Castilla y Leon
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Ponferrada, Castilla y Leon, Spanje, 24400
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Cataluña
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Centelles, Cataluña, Spanje, 08540
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Salt, Cataluña, Spanje, 17190
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Sant Boi de Llobregat, Cataluña, Spanje, 08830
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Viladecans, Cataluña, Spanje
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Extremadura
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Mérida, Extremadura, Spanje, 06800
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Bath, Verenigd Koninkrijk, BA1 2SR
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Bexhill-on-Sea, Verenigd Koninkrijk, TN40 1JJ
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Blackpool, Verenigd Koninkrijk, FY3 7EN
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Bradford, Verenigd Koninkrijk, BD9 6RJ
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Cambridge, Verenigd Koninkrijk, CB7 5JD
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Chesterfield, Verenigd Koninkrijk, S40 4AA
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Huntingdon, Verenigd Koninkrijk, PE29 6NT
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Manchester, Verenigd Koninkrijk, M20 2RN
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Newcastle-upon-Tyne, Verenigd Koninkrijk, NE7 7DN
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Newton Aycliffe, Verenigd Koninkrijk, DL5 4SE
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Reading, Verenigd Koninkrijk, RG7 3SQ
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Southbourne, Verenigd Koninkrijk
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Telford, Verenigd Koninkrijk, TF1 6TF
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Watford, Verenigd Koninkrijk, WD25 0EA
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Wiltshire, Verenigd Koninkrijk, SN15 2SB
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County Durham
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Burnhope, County Durham, Verenigd Koninkrijk, DH7 0BD
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Suffolk
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Alderton, Suffolk, Verenigd Koninkrijk, IP12 3DA
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Warwickshire
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Atherstone, Warwickshire, Verenigd Koninkrijk, CV9 1EU
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Leamington Spa, Warwickshire, Verenigd Koninkrijk, CV32 4RA
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Yorkshire
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Strensall, Yorkshire, Verenigd Koninkrijk, YO32 5UA
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: NVA237 + indacaterol
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NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Andere namen:
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Placebo-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Trough Forced Expiratory Volume at 1 Second (FEV1)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2012
Primaire voltooiing (Werkelijk)
1 januari 2013
Studie voltooiing (Werkelijk)
1 januari 2013
Studieregistratiedata
Eerst ingediend
21 mei 2012
Eerst ingediend dat voldeed aan de QC-criteria
21 mei 2012
Eerst geplaatst (Schatting)
23 mei 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
14 november 2014
Laatste update ingediend die voldeed aan QC-criteria
12 november 2014
Laatst geverifieerd
1 november 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Longziekten
- Longziekten, obstructief
- Longziekte, chronisch obstructief
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Muscarine-antagonisten
- Cholinerge antagonisten
- Cholinerge middelen
- Adjuvantia, anesthesie
- Anticonvulsiva
- Glycopyrrolaat
- Bromiden
Andere studie-ID-nummers
- CNVA237A2316
- 2011-005673-23 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .