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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indacaterol 150 µg
Salmeterol 50 µg
Placebo to indacaterol
Placebo to salmeterol
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring respiratory, dyspnea, breathlessness, COPD, indacaterol, long-acting β2-agonist

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
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  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Center
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
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  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indacaterol 150 µg

Salmeterol 50 µg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) 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.

Full Information

First Posted
January 9, 2009
Last Updated
July 22, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00821093
Brief Title
Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
INSIST
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
respiratory, dyspnea, breathlessness, COPD, indacaterol, long-acting β2-agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 150 µg
Arm Type
Experimental
Arm Description
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.
Arm Title
Salmeterol 50 µg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Indacaterol 150 µg
Intervention Description
Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Salmeterol 50 µg
Intervention Description
Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).
Intervention Type
Drug
Intervention Name(s)
Placebo to indacaterol
Intervention Description
Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Placebo to salmeterol
Intervention Description
Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)
Secondary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)
Description
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.
Time Frame
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
21367594
Citation
Korn S, Kerwin E, Atis S, Amos C, Owen R, Lassen C; INSIST study group. Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study. Respir Med. 2011 May;105(5):719-26. doi: 10.1016/j.rmed.2011.02.008. Epub 2011 Mar 1.
Results Reference
derived

Learn more about this trial

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

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