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A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00557466

Last Updated: 2013-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-05-31

Brief Summary

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This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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indacaterol 62.5 μg

Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type EXPERIMENTAL

indacaterol

Intervention Type DRUG

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

placebo to formoterol

Intervention Type DRUG

Placebo AEROLIZER® device

short acting β2- agonist

Intervention Type DRUG

100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

indacaterol 125 μg

Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type EXPERIMENTAL

indacaterol

Intervention Type DRUG

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

placebo to formoterol

Intervention Type DRUG

Placebo AEROLIZER® device

short acting β2- agonist

Intervention Type DRUG

100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Indacaterol 250 μg

Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type EXPERIMENTAL

indacaterol

Intervention Type DRUG

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

placebo to formoterol

Intervention Type DRUG

Placebo AEROLIZER® device

short acting β2- agonist

Intervention Type DRUG

100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

indacaterol 500 μg

Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type EXPERIMENTAL

indacaterol

Intervention Type DRUG

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

placebo to formoterol

Intervention Type DRUG

Placebo AEROLIZER® device

short acting β2- agonist

Intervention Type DRUG

100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

formoterol

Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type ACTIVE_COMPARATOR

formoterol

Intervention Type DRUG

Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.

placebo to indacaterol

Intervention Type DRUG

Placebo TWISTHALER® device

short acting β2- agonist

Intervention Type DRUG

100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

placebo

Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type PLACEBO_COMPARATOR

placebo to indacaterol

Intervention Type DRUG

Placebo TWISTHALER® device

placebo to formoterol

Intervention Type DRUG

Placebo AEROLIZER® device

short acting β2- agonist

Intervention Type DRUG

100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Interventions

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indacaterol

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

Intervention Type DRUG

formoterol

Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.

Intervention Type DRUG

placebo to indacaterol

Placebo TWISTHALER® device

Intervention Type DRUG

placebo to formoterol

Placebo AEROLIZER® device

Intervention Type DRUG

short acting β2- agonist

100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)
* Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

* Smoking history of at least 10 pack years
* Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% and ≥30% of the predicted normal value.
* Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%

Exclusion Criteria

* Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
* Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
* Patients with a history of asthma.
* Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
* Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharma AG

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Investigator site

Buenos Aires, , Argentina

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Rosario, , Argentina

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Santillán, , Argentina

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Liège, , Belgium

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Santiago, , Chile

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Val Pariso, , Chile

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Bois-Guillaume, , France

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Clermot Ferand, , France

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Lille, , France

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Marseille, , France

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Nantes, , France

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Toulouse, , France

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Berlin, , Germany

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Bibertal, , Germany

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Bochum, , Germany

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Bonn, , Germany

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Cologne, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Koblenz, , Germany

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Marburg, , Germany

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Solingen, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Pécs, , Hungary

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Dublin, , Ireland

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Genova, , Italy

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Napoli, , Italy

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Pordenone, , Italy

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Daugavpils, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Tronheim, , Norway

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Lima, , Peru

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Izabelin, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Mrozy, , Poland

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Olsztyn, , Poland

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Rzeszów, , Poland

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Wejhrowo, , Poland

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Włocławek, , Poland

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Iași, , Romania

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Timișoara, , Romania

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Bloemfontain, , South Africa

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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eManzimtoti, , South Africa

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George, , South Africa

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Johannesburg, , South Africa

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Port Elizabeth, , South Africa

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Pretoria, , South Africa

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Tygerberg, , South Africa

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Erzurum, , Turkey (Türkiye)

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Isparta, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Kahramanmaraş, , Turkey (Türkiye)

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Kayseri, , Turkey (Türkiye)

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Malatya, , Turkey (Türkiye)

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Manisa, , Turkey (Türkiye)

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Sanliurfa, , Turkey (Türkiye)

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Trabzon, , Turkey (Türkiye)

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Belfast, , United Kingdom

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Chesterfield, , United Kingdom

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Glasgow, , United Kingdom

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Plymouth, , United Kingdom

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Warminster, , United Kingdom

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Watford, , United Kingdom

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Whitstable, , United Kingdom

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Countries

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Argentina Belgium Chile France Germany Hungary Ireland Italy Latvia Lithuania Norway Peru Poland Romania South Africa Turkey (Türkiye) United Kingdom

Other Identifiers

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CQMF149B2201

Identifier Type: -

Identifier Source: org_study_id

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