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Effect of Indacaterol on Inspiratory Capacity (IC)

16 lutego 2016 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

173

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lek: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lek: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Eksperymentalny: 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.
Lek: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lek: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lek: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Eksperymentalny: 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.
Lek: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lek: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lek: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Eksperymentalny: 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.
Lek: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lek: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lek: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Eksperymentalny: 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.
Lek: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lek: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lek: Placebo
Placebo to indacaterol o.d. delivered via SDDPI
Eksperymentalny: 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.
Lek: Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Lek: Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
Lek: Placebo
Placebo to indacaterol o.d. delivered via SDDPI

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Peak Inspiratory Capacity (IC) After 21 Days of Treatment
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Trough IC After 20 Days of Treatment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2009

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2011

Daty rejestracji na studia

Pierwszy przesłany

11 listopada 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 listopada 2009

Pierwszy wysłany (Oszacować)

13 listopada 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

17 lutego 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 lutego 2016

Ostatnia weryfikacja

1 lutego 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CQAB149BDE01
  • EUDRACT No.: 2009-013686-26 (Inny identyfikator: EUDRACT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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