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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
449
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brussel, Belgien, 1090
- Novartis Investigative Site
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Bruxelles, Belgien, 1070
- Novartis Investigative Site
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Genk, Belgien, 3600
- Novartis Investigative Site
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Gilly, Belgien, 6060
- Novartis Investigative Site
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Gosselies, Belgien, 6041
- Novartis Investigative Site
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Hasselt, Belgien, 3500
- Novartis Investigative Site
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Herentals, Belgien, 2200
- Novartis Investigative Site
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Jambes, Belgien, 5100
- Novartis Investigative Site
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Liège, Belgien, 4000
- Novartis Investigative Site
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Luxembourg, Belgien, 1210
- Novartis Investigative Site
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Malmedy/Bellevaux-Ligneuville, Belgien, 4960
- Novartis Investigative Site
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Montigny-le-tilleul, Belgien, 6110
- Novartis Investigative Site
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Turnhout, Belgien, 2300
- Novartis Investigative Site
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Yvoir, Belgien, 5530
- Novartis Investigative Site
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Pleven, Bulgarien, 5800
- Novartis Investigative Site
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Plovdiv, Bulgarien, 4002
- Novartis Investigative Site
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Ruse, Bulgarien, 7002
- Novartis Investigative Site
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Sofia, Bulgarien, 1431
- Novartis Investigative Site
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Sofia, Bulgarien, 1606
- Novartis Investigative Site
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Sofia, Bulgarien, 1000
- Novartis Investigative Site
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Stara Zagora, Bulgarien, 6000
- Novartis Investigative Site
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Varna, Bulgarien, 9010
- Novartis Investigative Site
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Moscow, Den Russiske Føderation, 125315
- Novartis Investigative Site
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N.Novgorod, Den Russiske Føderation, 603126
- Novartis Investigative Site
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Nizhny Novgorod, Den Russiske Føderation, 603018
- Novartis Investigative Site
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Saratov, Den Russiske Føderation, 410012
- Novartis Investigative Site
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Bath, Det Forenede Kongerige, BA1 2SR
- Novartis Investigative Site
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Bexhill-on-Sea, Det Forenede Kongerige, TN40 1JJ
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Blackpool, Det Forenede Kongerige, FY3 7EN
- Novartis Investigative Site
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Bradford, Det Forenede Kongerige, BD9 6RJ
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Cambridge, Det Forenede Kongerige, CB7 5JD
- Novartis Investigative Site
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Chesterfield, Det Forenede Kongerige, S40 4AA
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Huntingdon, Det Forenede Kongerige, PE29 6NT
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Manchester, Det Forenede Kongerige, M20 2RN
- Novartis Investigative Site
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Newcastle-upon-Tyne, Det Forenede Kongerige, NE7 7DN
- Novartis Investigative Site
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Newton Aycliffe, Det Forenede Kongerige, DL5 4SE
- Novartis Investigative Site
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Reading, Det Forenede Kongerige, RG7 3SQ
- Novartis Investigative Site
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Southbourne, Det Forenede Kongerige
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Telford, Det Forenede Kongerige, TF1 6TF
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Watford, Det Forenede Kongerige, WD25 0EA
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Wiltshire, Det Forenede Kongerige, SN15 2SB
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County Durham
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Burnhope, County Durham, Det Forenede Kongerige, DH7 0BD
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Suffolk
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Alderton, Suffolk, Det Forenede Kongerige, IP12 3DA
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Warwickshire
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Atherstone, Warwickshire, Det Forenede Kongerige, CV9 1EU
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Leamington Spa, Warwickshire, Det Forenede Kongerige, CV32 4RA
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Yorkshire
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Strensall, Yorkshire, Det Forenede Kongerige, YO32 5UA
- Novartis Investigative Site
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Athens, Grækenland, 11527
- Novartis Investigative Site
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GR
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Athens, GR, Grækenland, 115 27
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Athens, GR, Grækenland, 106 76
- Novartis Investigative Site
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Thessaloniki, GR, Grækenland, 564 03
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Cork
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Wilton, Cork, Irland
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Ankara, Kalkun, 06490
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Istanbul, Kalkun, 34854
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Istanbul, Kalkun
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Kocaeli, Kalkun, 41380
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Mersin, Kalkun, 33079
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Yenisehir/Izmir, Kalkun, 35110
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Bratislava, Slovakiet, 826 06
- Novartis Investigative Site
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Kosice, Slovakiet, 040 01
- Novartis Investigative Site
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Kralovsky Chlmec, Slovakiet, 077 01
- Novartis Investigative Site
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Slovak Republic
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Bardejov, Slovak Republic, Slovakiet, 085 01
- Novartis Investigative Site
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Bojnice, Slovak Republic, Slovakiet, 972 01
- Novartis Investigative Site
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Liptovsky Hradok, Slovak Republic, Slovakiet, 033 01
- Novartis Investigative Site
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Slovensko
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Námestovo, Slovensko, Slovakiet, 02901
- Novartis Investigative Site
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Barcelona, Spanien, 08025
- Novartis Investigative Site
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Andalucia
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Malaga, Andalucia, Spanien, 29010
- Novartis Investigative Site
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Asturias
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Gijon, Asturias, Spanien, 33290
- Novartis Investigative Site
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Cantabria
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Torrelavega, Cantabria, Spanien, 39300
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Castilla la Mancha
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Illescas, Castilla la Mancha, Spanien, 45200
- Novartis Investigative Site
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Castilla y Leon
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Ponferrada, Castilla y Leon, Spanien, 24400
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Cataluña
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Centelles, Cataluña, Spanien, 08540
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Salt, Cataluña, Spanien, 17190
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Sant Boi de Llobregat, Cataluña, Spanien, 08830
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Viladecans, Cataluña, Spanien
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Extremadura
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Mérida, Extremadura, Spanien, 06800
- Novartis Investigative Site
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Budapest, Ungarn, 1121
- Novartis Investigative Site
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Budapest, Ungarn, 1046
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Deszk, Ungarn, 6772
- Novartis Investigative Site
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Erd, Ungarn, H-2030
- Novartis Investigative Site
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Godollo, Ungarn, 2100
- Novartis Investigative Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: NVA237 + indacaterol
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NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Andre navne:
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Placebo komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Trough Forced Expiratory Volume at 1 Second (FEV1)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2012
Primær færdiggørelse (Faktiske)
1. januar 2013
Studieafslutning (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først indsendt
21. maj 2012
Først indsendt, der opfyldte QC-kriterier
21. maj 2012
Først opslået (Skøn)
23. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. november 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. november 2014
Sidst verificeret
1. november 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Lungesygdomme
- Lungesygdomme, obstruktiv
- Lungesygdom, kronisk obstruktiv
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Muskarine antagonister
- Kolinerge antagonister
- Kolinerge midler
- Adjuvanser, anæstesi
- Antikonvulsiva
- Glycopyrrolat
- Bromider
Andre undersøgelses-id-numre
- CNVA237A2316
- 2011-005673-23 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med NVA237 50 µg and indacaterol 150 µg
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Statens Serum InstitutAfsluttet
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Novartis PharmaceuticalsAfsluttetAstmaTyskland, Det Forenede Kongerige
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Universiteit AntwerpenAfsluttetCOVID-19 | Coronavirussygdom 2019Belgien
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Eleusis TherapeuticsAfsluttetSund og raskDet Forenede Kongerige
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SkinJect, Inc.Afsluttet
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Guangzhou Patronus Biotech Co., Ltd.Yantai Patronus Biotech Co., Ltd.Aktiv, ikke rekrutterende
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ImmunityBio, Inc.Trukket tilbage
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Novartis PharmaceuticalsAfsluttetKronisk obstruktiv lungesygdom (KOL)Forenede Stater, Tyskland, Spanien, Kalkun, Ungarn, Tjekkiet, Indien, Slovakiet
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BlueWillow BiologicsPorton Biopharma Ltd.Afsluttet