Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

PHASE3CompletedINTERVENTIONAL
Enrollment

1,732

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Indacaterol

Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

DRUG

Formoterol

Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).

DRUG

Placebo to indacaterol

Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

DRUG

Placebo to formoterol

Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).

Trial Locations (183)

Unknown

Novartis Investigator Site, Buenos Aires

Novartis, Buenos Aires

Novartis Investigator Site, Mendoza

Novartis Investigator Site, San Miguel

Novartis Investigator Site, Santa Fe

Novartis Investigator Site, Rancagua

Novartis, Santiago

Novartis Investigator Site, Viña del Mar

Novartis Investigator Site, Barranquilla

Novartis, Bogotá

Novartis Investigator Site, Medellín

Novartis Investigator Site, Cvikov

Novartis Investigator Site, Kyjov

Novartis Investigator Site, Ostrava Poruba

Novartis Investigator Site, Pardubice

Novartis, Prague

Novartis Investigator Site, Tábor

Novartis Investigator Site, Žatec

Novartis Investigator Site, Aarhus

Novartis, Copenhagen

Novartis Investigator Site, Hellerup

Novartis Investigator Site, Hvidovre

Novartis Investigator Site, Molleparkvej

Novartis Investigator Site, Odense

Novartis Investigator Site, Guayaquil

Novartis Investigator Site, Quito

Novartis, Quito

Novartis Investigator Site, Alexandria

Novartis Investigator Site, Asyut

Novartis Investigator Site, Cairo

Novartis, Cairo

Novartis Investigator Site, Tallinn

Novartis, Tartu

Novartis Investigator Site, Beuvry

Novartis Investigator Site, Chamalières

Novartis Investigator Site, Férolles-Attilly

Novartis Investigator Site, Grasse

Novartis Investigator Site, Marseille

Novartis Investigator Site, Montpellier

Novartis Investigator Site, Nice

Novartis Investigator Site, Nîmes

Novartis Investigator Site, Paris

Novartis Investigator Site, Perpignan

Novartis Investigator Site, Pessac

Novartis Investigator Site, Strasbourg

Novartis Investigator Site, Augsburg

Novartis Investigator Site, Bad Segeberg

Novartis Investigator Site, Bad Wörishofen

Novartis Investigator Site, Berlin

Novartis Investigator Site, Bielefeld

Novartis Investigator Site, Bochum

Novartis Investigator Site, Bonn

Novartis Investigator Site, Borstel

Novartis Investigator Site, Darmstadt

Novartis Investigator Site, Dortmund

Novartis Investigator Site, Erfurt

Novartis Investigator Site, Forchheim

Novartis Investigator Site, Frankfurt

Novartis Investigator Site, Gauting

Novartis Investigator Site, Geesthacht

Novartis Investigator Site, Gelsenkirchen

Novartis Investigator Site, Großhansdorf

Novartis Investigator Site, Gummersbach

Novartis Investigator Site, Hagen

Novartis Investigator Site, Hamburg

Novartis Investigator Site, Hanover

Novartis Investigator Site, Ilvesheim

Novartis Investigator Site, Kassel

Novartis Investigator Site, Kiel

Novartis Investigator Site, Leipzig

Novartis Investigator Site, Lübeck

Novartis Investigator Site, Lüdenscheid

Novartis Investigator Site, Mainz

Novartis Investigator Site, Marburg

Novartis Investigator Site, München

Novartis Investigator Site, Neumünster

Novartis, Nuremberg

Novartis Investigator Site, Oschersleben

Novartis Investigator Site, Rüdersdorf

Novartis Investigator Site, Schönefeld

Novartis Investigator Site, Strausberg

Novartis Investigator Site, Witten

Novartis Investigator Site, Wuppertal

Novartis Investigator Site, Budapest

Novartis, Budapest

Novartis Investigator Site, Deszk

Novartis Investigator Site, Mátraháza

Novartis Investigator Site, Mosdós

Novartis Investigator Site, Sopron

Novartis Investigator Site, Jerusalem

Novartis, Petah Tikva

Novartis Investigator Site, Rehovot

Novartis Investigator Site, Tel Litwinsky

Novartis Investigator Site, Ancona

Novartis Investigator Site, Catania

Novartis Investigator Site, Ferrara

Novartis Investigator Site, Florence

Novartis Investigator Site, Foggia

Novartis Investigator Site, Genova

Novartis Investigator Site, Milan

Novartis, Milan

Novartis Investigator Site, Pisa

Novartis Investigator Site, Roma

Novartis Investigator Site, Siena

Novartis Investigator Site, Daugavpils

Novartis Investigator Site, Jēkabpils

Novartis Investigator Site, Riga

Novartis, Riga

Novartis Investigator Site, Alytus

Novartis Investigator Site, Kaunas

Novartis, Kaunas

Novartis Investigator Site, Klaipėda

Novartis Investigator Site, Vilnius

Novartis Investigator Site, Almelo

Novartis Investigator Site, Amersfoort

Novartis, Arnhem

Novartis Investigator Site, Breda

Novartis Investigator Site, Ede

Novartis Investigator Site, Eindhoven

Novartis Investigator Site, Harderwijk

Novartis Investigator Site, Helmond

Novartis Investigator Site, Hengelo

Novartis Investigator Site, Hoorn

Novartis Investigator Site, Leeuwarden

Novartis Investigator Site, Rotterdam

Novartis Investigator Site, Sneek

Novartis Investigator Site, Veldhoven

Novartis Investigator Site, Zutphen

Novartis Investigator Site, Lima

Novartis, Lima

Novartis, Bucharest

Novartis Investigator Site, Cluj-Napoca

Novartis Investigator Site, Iași

Novartis Investigator Site, Timișoara

Novartis Investigator Site, Kazan'

Novartis Investigator Site, Moscow

Novartis, Moscow

Novartis Investigator Site, Saint Petersburg

Novartis Investigator Site, Samara

Novartis Investigator Site, Yekaterinburg

Novartis Investigator Site, Banská Bystrica

Novartis Investigator Site, Bratislava

Novartis, Bratislava

Novartis Investigator Site, Košice

Novartis Investigator Site, Partizánske

Novartis Investigator Site, Kyunggi

Novartis Investigator Site, Seoul

Novartis, Seoul

Novartis Investigator Site, Suwon

Novartis Investigator Site, Uijeongbu-si

Novartis Investigator Site, Alicante

Novartis Investigator Site, Barcelona

Novartis, Barcelona

Novartis Investigator Site, Begonte

Novartis Investigator Site, Cáceres

Novartis Investigative Site, Madrid

Novartis Investigator Site, Mataró

Novartis Investigator Site, Petrel

Novartis Investigator Site, Ponferrada

Novartis Investigator Site, Terrassa

Novartis Investigator Site, Valencia

Novartis Investigator Site, Aarau

Novartis Investigator Site, Basel

Novartis Investigator Site, Locarno

Novartis Investigator Site, Münchenstein

Novartis Investigator Site, Zurich

Novartis Investigator Site, Ankara

Novartis Investigator Site, Bursa

Novartis, Istanbul

Novartis Investigator Site, Izmir

Novartis Investigator Site, Mersin

Novartis Investigator Site, Yenişehir

Novartis Investigator Site, Belfast

Novartis Investigator Site, Bexhill-on-Sea

Novartis Investigator Site, Blackpool

Novartis Investigator Site, Chertsey

Novartis Investigator Site, Glasgow

Novartis Investigator Site, Leicester

Novartis Investigator Site, London

Novartis Investigator Site, Manchester

Novartis Investigator Site, Newcastle upon Tyne

Novartis Investigator Site, Slough

Novartis Investigator Site, Swansea

Sponsors

Lead Sponsor

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Novartis

INDUSTRY

NCT00393458 - Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control | Biotech Hunter | Biotech Hunter