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)
keskiviikko 12. marraskuuta 2014 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
449
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Brussel, Belgia, 1090
- Novartis Investigative Site
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Bruxelles, Belgia, 1070
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Genk, Belgia, 3600
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Gilly, Belgia, 6060
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Gosselies, Belgia, 6041
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Hasselt, Belgia, 3500
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Herentals, Belgia, 2200
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Jambes, Belgia, 5100
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Liège, Belgia, 4000
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Luxembourg, Belgia, 1210
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Malmedy/Bellevaux-Ligneuville, Belgia, 4960
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Montigny-le-tilleul, Belgia, 6110
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Turnhout, Belgia, 2300
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Yvoir, Belgia, 5530
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Ruse, Bulgaria, 7002
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1000
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Stara Zagora, Bulgaria, 6000
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Varna, Bulgaria, 9010
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Barcelona, Espanja, 08025
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Andalucia
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Malaga, Andalucia, Espanja, 29010
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Asturias
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Gijon, Asturias, Espanja, 33290
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Cantabria
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Torrelavega, Cantabria, Espanja, 39300
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Castilla la Mancha
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Illescas, Castilla la Mancha, Espanja, 45200
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Castilla y Leon
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Ponferrada, Castilla y Leon, Espanja, 24400
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Cataluña
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Centelles, Cataluña, Espanja, 08540
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Salt, Cataluña, Espanja, 17190
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Sant Boi de Llobregat, Cataluña, Espanja, 08830
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Viladecans, Cataluña, Espanja
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Extremadura
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Mérida, Extremadura, Espanja, 06800
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Cork
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Wilton, Cork, Irlanti
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Athens, Kreikka, 11527
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GR
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Athens, GR, Kreikka, 115 27
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Athens, GR, Kreikka, 106 76
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Thessaloniki, GR, Kreikka, 564 03
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Bratislava, Slovakia, 826 06
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Kosice, Slovakia, 040 01
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Kralovsky Chlmec, Slovakia, 077 01
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Slovak Republic
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Bardejov, Slovak Republic, Slovakia, 085 01
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Bojnice, Slovak Republic, Slovakia, 972 01
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Liptovsky Hradok, Slovak Republic, Slovakia, 033 01
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Slovensko
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Námestovo, Slovensko, Slovakia, 02901
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Ankara, Turkki, 06490
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Istanbul, Turkki, 34854
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Istanbul, Turkki
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Kocaeli, Turkki, 41380
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Mersin, Turkki, 33079
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Yenisehir/Izmir, Turkki, 35110
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Budapest, Unkari, 1121
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Budapest, Unkari, 1046
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Deszk, Unkari, 6772
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Erd, Unkari, H-2030
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Godollo, Unkari, 2100
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Moscow, Venäjän federaatio, 125315
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N.Novgorod, Venäjän federaatio, 603126
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Nizhny Novgorod, Venäjän federaatio, 603018
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Saratov, Venäjän federaatio, 410012
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Bath, Yhdistynyt kuningaskunta, BA1 2SR
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Bexhill-on-Sea, Yhdistynyt kuningaskunta, TN40 1JJ
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Blackpool, Yhdistynyt kuningaskunta, FY3 7EN
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Bradford, Yhdistynyt kuningaskunta, BD9 6RJ
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Cambridge, Yhdistynyt kuningaskunta, CB7 5JD
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Chesterfield, Yhdistynyt kuningaskunta, S40 4AA
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Huntingdon, Yhdistynyt kuningaskunta, PE29 6NT
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Manchester, Yhdistynyt kuningaskunta, M20 2RN
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Newcastle-upon-Tyne, Yhdistynyt kuningaskunta, NE7 7DN
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Newton Aycliffe, Yhdistynyt kuningaskunta, DL5 4SE
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Reading, Yhdistynyt kuningaskunta, RG7 3SQ
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Southbourne, Yhdistynyt kuningaskunta
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Telford, Yhdistynyt kuningaskunta, TF1 6TF
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Watford, Yhdistynyt kuningaskunta, WD25 0EA
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Wiltshire, Yhdistynyt kuningaskunta, SN15 2SB
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County Durham
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Burnhope, County Durham, Yhdistynyt kuningaskunta, DH7 0BD
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Suffolk
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Alderton, Suffolk, Yhdistynyt kuningaskunta, IP12 3DA
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Warwickshire
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Atherstone, Warwickshire, Yhdistynyt kuningaskunta, CV9 1EU
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Leamington Spa, Warwickshire, Yhdistynyt kuningaskunta, CV32 4RA
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Yorkshire
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Strensall, Yorkshire, Yhdistynyt kuningaskunta, YO32 5UA
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
40 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: NVA237 + indacaterol
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NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Muut nimet:
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Placebo Comparator: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Trough Forced Expiratory Volume at 1 Second (FEV1)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
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Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. toukokuuta 2012
Ensisijainen valmistuminen (Todellinen)
Tiistai 1. tammikuuta 2013
Opintojen valmistuminen (Todellinen)
Tiistai 1. tammikuuta 2013
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 21. toukokuuta 2012
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 21. toukokuuta 2012
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 23. toukokuuta 2012
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 14. marraskuuta 2014
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 12. marraskuuta 2014
Viimeksi vahvistettu
Lauantai 1. marraskuuta 2014
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Keuhkosairaudet
- Keuhkosairaudet, obstruktiiviset
- Keuhkosairaus, krooninen obstruktiivinen
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Muskariiniantagonistit
- Kolinergiset antagonistit
- Kolinergiset aineet
- Adjuvantit, anestesia
- Antikonvulsantit
- Glykopyrrolaatti
- Bromidit
Muut tutkimustunnusnumerot
- CNVA237A2316
- 2011-005673-23 (EudraCT-numero)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .