Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD) (INSIST)

July 22, 2011 updated by: Novartis Pharmaceuticals

A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler

This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1123

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

  • Czech Republic
      • Cvikov, Czech Republic
        • Novartis Investigator Site
      • Kyjov, Czech Republic
        • Novartis Investigator Site
      • Lovosice, Czech Republic
        • Novartis Investigator Site
      • Neratovice, Czech Republic
        • Novartis Investigator Site
      • Ostrava, Czech Republic
        • Novartis Investigator Site
      • Pardubice, Czech Republic
        • Novartis Investigator Site
      • Prague, Czech Republic
        • Novartis Investigator Site
      • Teplice, Czech Republic
        • Novartis Investigator Site
  • Germany
      • Aschaffenburg, Germany
        • Novartis Investigative Site
      • Augsburg, Germany
        • Novartis Investigative Site
      • Backnang, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigator Site
      • Bielefeld, Germany
        • Novartis Investigative Site
      • Borstel, Germany
        • Novartis Investigative Site
      • Dortmund, Germany
        • Novartis Investigative Site
      • Duisburg, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigator Site
      • Geesthacht, Germany
        • Novartis Investigative Site
      • Hagen, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Karlsruhe, Germany
        • Novartis Investigative Site
      • Kiel, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigator Site
      • Lübeck, Germany
        • Novartis Investigative Site
      • Mainz, Germany
        • Novartis Investigative Site
      • Marburg, Germany
        • Novartis Investigative Site
      • Neumuenster, Germany
        • Novartis Investigative Site
      • Oschersleben, Germany
        • Novartis Investigative Site
      • Ruedersdorf, Germany
        • Novartis Investigative Site
      • Weyhe, Germany
        • Novartis Investigative Site
      • Wiesloch, Germany
        • Novartis Investigative Site
      • Witten, Germany
        • Novartis Investgative Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigator Site
      • Debrecen, Hungary
        • Novartis Investigator Site
      • Deszk, Hungary
        • Novartis Investigative Site
      • Mosonmagyarovar, Hungary
        • Novartis Investigator Site
      • Nyiregyhaza, Hungary
        • Novartis Investigator Site
      • Tatabanya, Hungary
        • Novartis Investigator Site
      • Torokbalint, Hungary
        • Novartis Investigator Site
  • India
      • Chennai, India
        • Novartis Investigator Site
      • Hyderabad, India
        • Novartis Investigator Site
      • Jaipur, India
        • Novartis Investigator Site
      • Mangalore, India
        • Novartis Investigator Site
      • Panjim, India
        • Novartis Investigator Site
      • Pune, India
        • Novartis Investigator Site
      • Trivandrum, India
        • Novartis Investigator Site
      • Vellore, India
        • Novartis Investigator Site
  • Slovakia
      • Bojnice, Slovakia
        • Novartis Investigative Site
      • Bratislava, Slovakia
        • Novartis Investigator Site
      • Humenne, Slovakia
        • Novartis Investigative Site
      • Kosice, Slovakia
        • Novartis Investigative Site
      • Liptovsky Hradok, Slovakia
        • Novartis Investigator Site
      • Partizanske, Slovakia
        • Novartis Investigative Site
      • Spisska Nova Ves, Slovakia
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain
        • Novartis Investigator Site
      • Barcelona, Spain
        • Novartis Investigative Site
      • Caceres, Spain
        • Novartis Investigative Site
      • Cordoba, Spain
        • Novartis Investigative Site
      • La Coruna, Spain
        • Novartis Investigative Site
      • Merida, Spain
        • Novartis Investigative Site
      • Orense, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site
  • Turkey
      • Altunizade, Turkey
        • Novartis Investigative Site
      • Istanbul, Turkey
        • Novartis Investigator Site
      • Izmir, Turkey
        • Novartis Investigator Site
      • Kartal/Istanbul, Turkey
        • Novartis Investigator Site
      • Kinikli / Denizli, Turkey
        • Novartis Investigative Site
      • Mersin, Turkey
        • Novartis Investigative Site
      • Yenisehir/Izmir, Turkey
        • Novartis Investigator Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207-5710
        • Novartis Investigator Site
      • Fairhope, Alabama, United States, 36532
        • Novartis Investigator Site
      • Jasper, Alabama, United States, 35501
        • Novartis Investigator Site
      • Mobile, Alabama, United States, 36604
        • Novartis Investigator Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Novartis Investigator Site
      • Phoenix, Arizona, United States, 85006
        • Novartis Investigator Site
    • California
      • Buena Park, California, United States, 90620
        • Novartis Investigator Site
      • Encinitas, California, United States, 92024
        • Novartis Investigator Site
      • Fullerton, California, United States, 92535
        • Novartis Investigator Site
      • Rancho Mirage, California, United States, 92270
        • Novartis Investigator Site
      • Riverside, California, United States, 92506
        • Novartis Investigator Site
      • San Diego, California, United States, 92120
        • Novartis Investigator Site
      • Torrance, California, United States, 90505
        • Novartis Investigator Site
      • Walnut Creek, California, United States, 94598
        • Novartis Investigator Site
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Novartis Investigator Site
      • Wheat Ridge, Colorado, United States, 80033
        • Novartis Investigative Site
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Novartis Investigative Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Novartis Investigative Center
      • Pensacola, Florida, United States, 32504
        • Novartis Investigative Site
      • Pensacola, Florida, United States, 32514
        • Novartis Investigative Site
      • South Miami, Florida, United States, 33143
        • Novartis Investigative Site
      • Tamarac, Florida, United States, 33321
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33603
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33613
        • Novartis Investigative Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Novartis Investigative Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Novartis Investigator Site
      • River Forest, Illinois, United States, 60305
        • Novartis Investigator Site
      • Skokie, Illinois, United States, 60076
        • Novartis Investigator Site
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Novartis Investigator Site
      • Wichita, Kansas, United States, 67207
        • Novartis Investigator Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Novartis Investigator Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Novartis Investigator Site
      • Opelousas, Louisiana, United States, 70570
        • Novartis Investigator Site
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Novartis Investigator Site
      • Livonia, Michigan, United States, 48152
        • Novartis Investigator Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Novartis Investigator Site
    • Missouri
      • St Charles, Missouri, United States, 63301-2847
        • Novartis Investigator Site
      • St Louis, Missouri, United States, 63141
        • Novartis Investigator Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Novartis Investigator Site
      • Omaha, Nebraska, United States, 68134
        • Novartis Investigator Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Novartis Investigator Site
      • Reno, Nevada, United States, 89502
        • Novartis Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Novartis Investigative Site
      • Summit, New Jersey, United States, 07901
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Novartis Investigator Site
    • New York
      • Larchmont, New York, United States, 10538
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Novartis Investigative Site
      • Hickory, North Carolina, United States, 28601
        • Novartis Investigative Site
      • Raleigh, North Carolina, United States, 27607
        • Novartis Investigative Site
      • Shelby, North Carolina, United States, 28150
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novartis Investigator Site
      • Columbus, Ohio, United States, 42313
        • Novartis Investigator Site
      • Willoughby Hills, Ohio, United States, 44094
        • Novartis Investigator Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135-2920
        • Novartis Investigator Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Novartis Investigator Site
      • Medford, Oregon, United States, 97504-8741
        • Novartis Investigator Site
      • Portland, Oregon, United States, 97213
        • Novartis Investigator Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16506
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Novartis Investigative Site
      • Greenville, South Carolina, United States, 29615
        • Novartis Investigative Site
      • North Charleston, South Carolina, United States, 29406-7108
        • Novartis Investigative Site
      • Spartanburg, South Carolina, United States, 29303
        • Novartis Investigative Site
      • Union, South Carolina, United States, 29379
        • Novartis Investigative Site
    • Texas
      • El Paso, Texas, United States, 79903
        • Novartis Investigator Site
      • Fort Worth, Texas, United States, 76104
        • Novartis Investigator Site
      • Houston, Texas, United States, 77024
        • Novartis Investigator Site
      • San Antonio, Texas, United States, 78212
        • Novartis Investigator Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Novartis Investigative Site
      • Richmond, Virginia, United States, 23229
        • Novartis Investigative Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Novartis Investigator Site
      • Tacoma, Washington, United States, 98405-4266
        • Novartis Investigator Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209-0996
        • 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:

  • Adults aged ≥ 40 years

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the GOLD Guidelines, 2007) and:

    • Smoking history of at least 10 pack years
    • Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value at screening
    • Post-bronchodilator FEV1/FVC (forced vital capacity) < 70% at screening

Exclusion Criteria:

  • Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
  • Patients requiring long-term oxygen therapy (> 15 h a day) for chronic hypoxemia
  • Patients who have 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
  • Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
  • Patients with a history of long QT syndrome or whose QTc interval (Fridericia's) measured at screening is prolonged
  • Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
  • Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements

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 150 µg
Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. 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 150 µg
Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Drug: Placebo to salmeterol
Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).
Active Comparator: Salmeterol 50 µg
Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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: Salmeterol 50 µg
Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).
Drug: Placebo to indacaterol
Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84)
Time Frame: From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.
From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)
Time Frame: 24 hours post-dose at the end of the study (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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

January 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

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

  • CQAB149B2349
  • 2008-005146-23 (EudraCT Number)

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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