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

July 22, 2011 updated by: Novartis

A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1732

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Novartis
      • Buenos Aires, Argentina
        • Novartis Investigator Site
      • Mendoza, Argentina
        • Novartis Investigator Site
      • San Miguel, Argentina
        • Novartis Investigator Site
      • Santa Fe, Argentina
        • Novartis Investigator Site
  • Chile
      • Rancagua, Chile
        • Novartis Investigator Site
      • Santiago, Chile
        • Novartis
      • Vina del Mar, Chile
        • Novartis Investigator Site
  • Colombia
      • Barranquilla, Colombia
        • Novartis Investigator Site
      • Bogota, Colombia
        • Novartis
      • Medellin, Colombia
        • Novartis Investigator Site
  • Czech Republic
      • Cvikov, Czech Republic
        • Novartis Investigator Site
      • Kyjov, Czech Republic
        • Novartis Investigator Site
      • Ostrava Poruba, Czech Republic
        • Novartis Investigator Site
      • Pardubice, Czech Republic
        • Novartis Investigator Site
      • Praha, Czech Republic
        • Novartis
      • Tabor, Czech Republic
        • Novartis Investigator Site
      • Zatec, Czech Republic
        • Novartis Investigator Site
  • Denmark
      • Aarhus, Denmark
        • Novartis Investigator Site
      • Copenhagen, Denmark
        • Novartis
      • Hellerup, Denmark
        • Novartis Investigator Site
      • Hvidovre, Denmark
        • Novartis Investigator Site
      • Molleparkvej, Denmark
        • Novartis Investigator Site
      • Odense, Denmark
        • Novartis Investigator Site
  • Ecuador
      • Guayaquil, Ecuador
        • Novartis Investigator Site
      • Quito, Ecuador
        • Novartis Investigator Site
      • Quito, Ecuador
        • Novartis
  • Egypt
      • Alexandria, Egypt
        • Novartis Investigator Site
      • Assiut, Egypt
        • Novartis Investigator Site
      • Cairo, Egypt
        • Novartis Investigator Site
      • Cairo, Egypt
        • Novartis
  • Estonia
      • Tallinn, Estonia
        • Novartis Investigator Site
      • Tartu, Estonia
        • Novartis
  • France
      • Beuvry, France
        • Novartis Investigator Site
      • Chamalieres, France
        • Novartis Investigator Site
      • Ferolles-Attilly, France
        • Novartis Investigator Site
      • Grasse, France
        • Novartis Investigator Site
      • Marseilles, France
        • Novartis Investigator Site
      • Montpellier Cedex, France
        • Novartis Investigator Site
      • Nice, France
        • Novartis Investigator Site
      • Nimes, France
        • Novartis Investigator Site
      • Paris, France
        • Novartis Investigator Site
      • Perpignan, France
        • Novartis Investigator Site
      • Pessac Cedex, France
        • Novartis Investigator Site
      • Strasbourg, France
        • Novartis Investigator Site
  • Germany
      • Augsburg, Germany
        • Novartis Investigator Site
      • Bad Segeberg, Germany
        • Novartis Investigator Site
      • Bad Worishofen, Germany
        • Novartis Investigator Site
      • Berlin, Germany
        • Novartis Investigator Site
      • Bielefeld, Germany
        • Novartis Investigator Site
      • Bochum, Germany
        • Novartis Investigator Site
      • Bonn, Germany
        • Novartis Investigator Site
      • Borstel, Germany
        • Novartis Investigator Site
      • Darmstadt, Germany
        • Novartis Investigator Site
      • Dortmund, Germany
        • Novartis Investigator Site
      • Erfurt, Germany
        • Novartis Investigator Site
      • Forchheim, Germany
        • Novartis Investigator Site
      • Frankfurt, Germany
        • Novartis Investigator Site
      • Gauting, Germany
        • Novartis Investigator Site
      • Geesthacht, Germany
        • Novartis Investigator Site
      • Gelsenkirchen, Germany
        • Novartis Investigator Site
      • Grosshansdorf, Germany
        • Novartis Investigator Site
      • Gummersbach, Germany
        • Novartis Investigator Site
      • Hagen, Germany
        • Novartis Investigator Site
      • Hamburg, Germany
        • Novartis Investigator Site
      • Hannover, Germany
        • Novartis Investigator Site
      • Ilvesheim, Germany
        • Novartis Investigator Site
      • Kassel, Germany
        • Novartis Investigator Site
      • Kiel, Germany
        • Novartis Investigator Site
      • Leipzig, Germany
        • Novartis Investigator Site
      • Luebeck, Germany
        • Novartis Investigator Site
      • Luedenscheid, Germany
        • Novartis Investigator Site
      • Mainz, Germany
        • Novartis Investigator Site
      • Marburg, Germany
        • Novartis Investigator Site
      • Muenchen, Germany
        • Novartis Investigator Site
      • Neumunster, Germany
        • Novartis Investigator Site
      • Nürnberg, Germany
        • Novartis
      • Oschersleben, Germany
        • Novartis Investigator Site
      • Ruedersdorf, Germany
        • Novartis Investigator Site
      • Schoenefeld, Germany
        • Novartis Investigator Site
      • Strausberg, Germany
        • Novartis Investigator Site
      • Witten, Germany
        • Novartis Investigator Site
      • Wuppertal, Germany
        • Novartis Investigator Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigator Site
      • Budapest, Hungary
        • Novartis
      • Deszk, Hungary
        • Novartis Investigator Site
      • Matrahaza, Hungary
        • Novartis Investigator Site
      • Mosdos, Hungary
        • Novartis Investigator Site
      • Sopron, Hungary
        • Novartis Investigator Site
  • Israel
      • Jerusalem, Israel
        • Novartis Investigator Site
      • Petach-Tikva, Israel
        • Novartis
      • Rehovot, Israel
        • Novartis Investigator Site
      • Tel-Hashomer, Israel
        • Novartis Investigator Site
  • Italy
      • Ancona, Italy
        • Novartis Investigator Site
      • Catania, Italy
        • Novartis Investigator Site
      • Ferrara, Italy
        • Novartis Investigator Site
      • Firenze, Italy
        • Novartis Investigator Site
      • Foggia, Italy
        • Novartis Investigator Site
      • Genova, Italy
        • Novartis Investigator Site
      • Milano, Italy
        • Novartis Investigator Site
      • Milano, Italy
        • Novartis
      • Pisa, Italy
        • Novartis Investigator Site
      • Roma, Italy
        • Novartis Investigator Site
      • Siena, Italy
        • Novartis Investigator Site
  • Korea, Republic of
      • Kyunggi, Korea, Republic of
        • Novartis Investigator Site
      • Seoul, Korea, Republic of
        • Novartis Investigator Site
      • Seoul, Korea, Republic of
        • Novartis
      • Suwon, Korea, Republic of
        • Novartis Investigator Site
      • Uijeongbu-si, Korea, Republic of
        • Novartis Investigator Site
  • Latvia
      • Daugavpils, Latvia
        • Novartis Investigator Site
      • Jekabpils, Latvia
        • Novartis Investigator Site
      • Riga, Latvia
        • Novartis Investigator Site
      • Riga, Latvia
        • Novartis
  • Lithuania
      • Alytus, Lithuania
        • Novartis Investigator Site
      • Kaunas, Lithuania
        • Novartis Investigator Site
      • Kaunas, Lithuania
        • Novartis
      • Klaipeda, Lithuania
        • Novartis Investigator Site
      • Vilnius, Lithuania
        • Novartis Investigator Site
  • Netherlands
      • Almelo, Netherlands
        • Novartis Investigator Site
      • Amersfoort, Netherlands
        • Novartis Investigator Site
      • Arnhem, Netherlands
        • Novartis
      • Breda, Netherlands
        • Novartis Investigator Site
      • Ede, Netherlands
        • Novartis Investigator Site
      • Eindhoven, Netherlands
        • Novartis Investigator Site
      • Harderwijk, Netherlands
        • Novartis Investigator Site
      • Helmond, Netherlands
        • Novartis Investigator Site
      • Hengelo, Netherlands
        • Novartis Investigator Site
      • Hoorn, Netherlands
        • Novartis Investigator Site
      • Leeuwarden, Netherlands
        • Novartis Investigator Site
      • Rotterdam, Netherlands
        • Novartis Investigator Site
      • Sneek, Netherlands
        • Novartis Investigator Site
      • Veldhoven, Netherlands
        • Novartis Investigator Site
      • Zutphen, Netherlands
        • Novartis Investigator Site
  • Peru
      • Lima, Peru
        • Novartis Investigator Site
      • Lima, Peru
        • Novartis
  • Romania
      • Bucharest, Romania
        • Novartis
      • Cluj-Napoca, Romania
        • Novartis Investigator Site
      • Iasi, Romania
        • Novartis Investigator Site
      • Timisoara, Romania
        • Novartis Investigator Site
  • Russian Federation
      • Kazan, Russian Federation
        • Novartis Investigator Site
      • Moscow, Russian Federation
        • Novartis Investigator Site
      • Moscow, Russian Federation
        • Novartis
      • Samara, Russian Federation
        • Novartis Investigator Site
      • St Petersburg, Russian Federation
        • Novartis Investigator Site
      • Yekaterinburg, Russian Federation
        • Novartis Investigator Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Novartis Investigator Site
      • Bratislava, Slovakia
        • Novartis Investigator Site
      • Bratislava, Slovakia
        • Novartis
      • Kosice, Slovakia
        • Novartis Investigator Site
      • Partizanske, Slovakia
        • Novartis Investigator Site
  • Spain
      • Alicante, Spain
        • Novartis Investigator Site
      • Barcelona, Spain
        • Novartis Investigator Site
      • Barcelona, Spain
        • Novartis
      • Begonte, Spain
        • Novartis Investigator Site
      • Caceres, Spain
        • Novartis Investigator Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Mataro, Spain
        • Novartis Investigator Site
      • Petrel, Spain
        • Novartis Investigator Site
      • Ponferrada, Spain
        • Novartis Investigator Site
      • Terrassa, Spain
        • Novartis Investigator Site
      • Valencia, Spain
        • Novartis Investigator Site
  • Switzerland
      • Aarau, Switzerland
        • Novartis Investigator Site
      • Basel, Switzerland
        • Novartis Investigator Site
      • Locarno, Switzerland
        • Novartis Investigator Site
      • Munchenstein, Switzerland
        • Novartis Investigator Site
      • Zuerich, Switzerland
        • Novartis Investigator Site
  • Turkey
      • Ankara, Turkey
        • Novartis Investigator Site
      • Bursa, Turkey
        • Novartis Investigator Site
      • Istanbul, Turkey
        • Novartis
      • Izmir, Turkey
        • Novartis Investigator Site
      • Mersin, Turkey
        • Novartis Investigator Site
      • Yenisehir, Turkey
        • Novartis Investigator Site
  • United Kingdom
      • Belfast, United Kingdom
        • Novartis Investigator Site
      • Bexhill-on-Sea, United Kingdom
        • Novartis Investigator Site
      • Blackpool, United Kingdom
        • Novartis Investigator Site
      • Chertsey, United Kingdom
        • Novartis Investigator Site
      • Glasgow, United Kingdom
        • Novartis Investigator Site
      • Leicester, United Kingdom
        • Novartis Investigator Site
      • London, United Kingdom
        • Novartis Investigator Site
      • Manchester, United Kingdom
        • Novartis Investigator Site
      • Newcastle-upon-Tyne, United Kingdom
        • Novartis Investigator Site
      • Slough, United Kingdom
        • Novartis Investigator Site
      • Swansea, United Kingdom
        • Novartis Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:

    1. Smoking history of at least 20 pack years
    2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value

    3. Post-bronchodilator FEV1/FVC (forced volume capacity) < 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

      Exclusion Criteria:

  • Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
  • Patients who had a respiratory tract infection within 6 weeks prior to screening.
  • Patients with concomitant pulmonary disease.
  • Patients with a history of asthma.
  • Patients with diabetes type I or uncontrolled diabetes type II.
  • Any patient with lung cancer or a history of lung cancer.
  • Patients with a history of certain cardiovascular co-morbid conditions.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indacaterol 300 μg plus placebo to formoterol
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
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®).
Experimental: Indacaterol 600 μg plus placebo to formoterol
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
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®).
Active Comparator: Formoterol 12 μg plus placebo to indacaterol
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Placebo to indacaterol
Placebo to 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®).
Placebo Comparator: Placebo to indacaterol plus placebo to formoterol
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
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®).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
Time Frame: Week 12 + 1 day, Day 85
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Week 12 + 1 day, Day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Days of Poor Control During 52 Weeks of Treatment
Time Frame: Baseline to end of study (Week 52)
Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Baseline to end of study (Week 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Principal Investigator: Novartis Investigator Site, Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 27, 2006

Study Record Updates

Last Update Posted (Estimate)

August 18, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149B2334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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