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Effect of Indacaterol on Inspiratory Capacity (IC)

16. února 2016 aktualizováno: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control

This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

173

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

  • Německo
      • Aschaffenburg, Německo
        • Novartis Investigative Site
      • Berlin, Německo
        • Novartis Investigative Site
      • Dresden, Německo
        • Novartis Investigative Site
      • Erfurt, Německo
        • Novartis Investigative Site
      • Frankfurt am Main, Německo
        • Novartis Investigative Site
      • Fulda, Německo
        • Novartis Investigative Site
      • Geesthacht, Německo
        • Novartis Investigative Site
      • Großhansdorf, Německo
        • Novartis Investigative Site
      • Halle, Německo
        • Novartis Investigative Site
      • Hamburg, Německo
        • Novartis Investigative Site
      • Kiel, Německo
        • Novartis Investigative Site
      • Koblenz, Německo
        • Novartis Investigative Site
      • Leipzig, Německo
        • Novartis Investigative Site
      • Mannheim, Německo
        • Novartis Investigative Site
      • Marburg, Německo
        • Novartis Investigative Site
      • Neumünster, Německo
        • Novartis Investigative Site
      • Potsdam, Německo
        • Novartis Investigative Site
      • Rathenow, Německo
        • Novartis Investigative Site
      • Rüdersdorf, Německo
        • Novartis Investigative Site
      • Witten, Německo
        • Novartis Investigator Site
      • Zerbst, Německo
        • Novartis Investigative Site

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:

  • Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:

    • Smoking history of at least 10 pack years
    • Post-bronchodilator FEV1 <80% and ≥50% of the predicted normal value (Visit 2).
    • Post-bronchodilator FEV1/forced vital capacity (FVC) <70% (Visit 2).

Exclusion Criteria:

  • Patients who received any corticosteroid (including inhaled) for 3 months prior to screening

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: Crossover Assignment
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Indacaterol - placebo - tiotropium
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Lék: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lék: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lék: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Experimentální: Placebo - Tiotropium - Indacaterol
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Lék: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lék: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lék: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Experimentální: Tiotropium - indacaterol - placebo
In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Lék: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lék: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lék: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Experimentální: Placebo - indacaterol - tiotropium
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Lék: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lék: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lék: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Experimentální: Indacaterol - tiotropium - placebo
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Lék: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lék: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lék: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Experimentální: Tiotropium - placebo - indacaterol
In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Lék: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lék: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lék: Placebo
Placebo to indacaterol o.d. delivered via SDDPI

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Peak Inspiratory Capacity (IC) After 21 Days of Treatment
Časové okno: 21 days
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
21 days

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Trough IC After 20 Days of Treatment
Časové okno: 20 days
Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
20 days
Peak Residual Volume (RV) After 21 Days of Treatment
Časové okno: 21 days
Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
21 days
Peak Total Lung Capacity (TLC) After 21 Days of Treatment
Časové okno: 21 days
TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
21 days
Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
Časové okno: 21 days
Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
21 days
Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
Časové okno: 21 days
Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
21 days
FEV1 30 Minutes Post-dose After 21 Days of Treatment
Časové okno: 21 days
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
21 days
Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
Časové okno: 20 days
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
20 days

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novartis Pharmaceuticals

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

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. listopadu 2009

Primární dokončení (Aktuální)

1. ledna 2011

Termíny zápisu do studia

První předloženo

11. listopadu 2009

První předloženo, které splnilo kritéria kontroly kvality

12. listopadu 2009

První zveřejněno (Odhad)

13. listopadu 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

17. února 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. února 2016

Naposledy ověřeno

1. února 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CQAB149BDE01
  • EUDRACT No.: 2009-013686-26 (Jiný identifikátor: 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 .

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Podmínky

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