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Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

COPD

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indacaterol
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, adults, β2-agonist, indacaterol

Eligibility Criteria

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

Inclusion Criteria:

  • Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).

  • In addition the following inclusion/exclusion criteria specified below must be met.

    1. Patients must complete Stage 2 of the core study B2335S (NCT00463567).
    2. Written informed consent to participate in the extension must be obtained.
    3. Patients must be able to comply with all study requirements.

Exclusion Criteria:

  • Patients who were randomized to open-label tiotropium in Study B2335S.
  • Patients who participated in Stage 1 of the core study (B2335S).
  • Patients discontinued irrespective of the reason from Stage 2 of the core study.
  • Patients who fail to comply with the core protocol requirements and procedures.
  • Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
  • Patients who in the Investigator's opinion should not participate in the extension study.

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Indacaterol 150 µg

Indacaterol 300 µg

Placebo

Arm Description

Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Outcomes

Primary Outcome Measures

The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.
The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg.
The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg.
The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms.
Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52
The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.
Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52
The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.

Secondary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.
Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52
The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates. SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant.

Full Information

First Posted
May 13, 2008
Last Updated
August 18, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00677807
Brief Title
Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, adults, β2-agonist, indacaterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 150 µg
Arm Type
Experimental
Arm Description
Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Arm Title
Indacaterol 300 µg
Arm Type
Experimental
Arm Description
Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
Primary Outcome Measure Information:
Title
The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
Description
The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.
Time Frame
Up to 52 weeks
Title
The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
Description
The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg.
Time Frame
Up to 52 weeks
Title
The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
Description
The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg.
Time Frame
Up to 52 weeks
Title
The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
Description
The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms.
Time Frame
Up to 52 weeks
Title
Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52
Description
The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.
Time Frame
Weeks 12, 26, 36, 44 and 52
Title
Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52
Description
The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.
Time Frame
Weeks 12, 26, 36, 44 and 52
Secondary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment
Description
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.
Time Frame
Week 52
Title
Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52
Description
The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates. SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant.
Time Frame
Weeks 36, 44 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE). In addition the following inclusion/exclusion criteria specified below must be met. Patients must complete Stage 2 of the core study B2335S (NCT00463567). Written informed consent to participate in the extension must be obtained. Patients must be able to comply with all study requirements. Exclusion Criteria: Patients who were randomized to open-label tiotropium in Study B2335S. Patients who participated in Stage 1 of the core study (B2335S). Patients discontinued irrespective of the reason from Stage 2 of the core study. Patients who fail to comply with the core protocol requirements and procedures. Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol. Patients who in the Investigator's opinion should not participate in the extension study. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209-6870
Country
United States
Facility Name
Novartis Investigative Site
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Novartis Investigative Site
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
Novartis Investigative Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024-1332
Country
United States
Facility Name
Novartis Investigative SIte
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Novartis Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Novartis Investigative Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Novartis Investigative Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Novartis Investigative site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Novartis Investigative site
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Novartis Investigative Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Novartis Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Novartis Investigative Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
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
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Novartis Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Novartis Investigative Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Novartis Investigative Site
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Novartis Investigative Site
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Novartis Investigative Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
Novartis Investigative Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novartis Investigative Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novartis Investigative Site
City
Crescent Springs
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Novartis Investigative Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Novartis Investigative Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Novartis Investigative Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Novartis Investigative Site
City
Metaire
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Novartis Investigative site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Novartis Investigative Site
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
Novartis Investgative Site
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Novartis Investigative Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Novartis Investigative Site
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Novartis Investigative site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Novartis Investigative Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Novartis Investigative Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108-2677
Country
United States
Facility Name
Novartis Investigative Site
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Novartis Investigative Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Novartis Investigative Site
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5885
Country
United States
Facility Name
Novartis Investigative Site
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Novartis Investigative site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Novartis Investigative site
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Novartis Investigative Site
City
Elmira
State/Province
New York
ZIP/Postal Code
14905
Country
United States
Facility Name
Novartis Investigative site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-2638
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
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Novartis Investigative Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Novartis Investigative Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Novartis Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Facility Name
Novartis Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Novartis Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Novartis Investigative Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Novartis Investigative Site
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43650
Country
United States
Facility Name
Novartis Investigative Site
City
Thornville
State/Province
Ohio
ZIP/Postal Code
43076
Country
United States
Facility Name
Novartis Investigative Site
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novartis Investigative Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135-2920
Country
United States
Facility Name
Novartis Investigative Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404-3233
Country
United States
Facility Name
Novartis Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504-8741
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
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Novartis Investigative site
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Novartis Investigative Site
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
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
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Novartis Investigative Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novartis Investigative site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Novartis Investigative Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Novartis Investigative site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Novartis Investigative Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209-0996
Country
United States
Facility Name
Novartis Investigative site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative site
City
Rosario
Country
Argentina
Facility Name
Novartis Investigative site
City
Ajax
Country
Canada
Facility Name
Novartis Investigative site
City
Calgary
Country
Canada
Facility Name
Novartis Investigative site
City
Gatineau
Country
Canada
Facility Name
Novartis Investigative site
City
Moncton
Country
Canada
Facility Name
Novartis Investigative site
City
Montreal
Country
Canada
Facility Name
Novartis Investigative site
City
Niagara Falls
Country
Canada
Facility Name
Novartis Investigative site
City
Ottawa
Country
Canada
Facility Name
Novartis Investigative site
City
Quebec
Country
Canada
Facility Name
Novartis Investigative site
City
Saskatoon
Country
Canada
Facility Name
Novartis Investigative site
City
Sherbrooke
Country
Canada
Facility Name
Novartis Investigative site
City
St-Romuald
Country
Canada
Facility Name
Novartis Investigative site
City
St. John's
Country
Canada
Facility Name
Novartis Investigative site
City
St. John
Country
Canada
Facility Name
Novartis Investigative site
City
Toronto
Country
Canada
Facility Name
Novartis Investigative site
City
Trois-Rivières
Country
Canada
Facility Name
Novartis Investigative site
City
Vancouver
Country
Canada
Facility Name
Novartis Investigative site
City
Windsor
Country
Canada
Facility Name
Novartis Investigative site
City
Winnipeg
Country
Canada
Facility Name
Novartis Investigative site
City
Augsburg
Country
Germany
Facility Name
Novartis Investigative site
City
Bad Segeberg
Country
Germany
Facility Name
Novartis Investigative site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative site
City
Bielefeld
Country
Germany
Facility Name
Novartis Investigative site
City
Bonn
Country
Germany
Facility Name
Novartis Investigative site
City
Dachau
Country
Germany
Facility Name
Novartis Investigative site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative site
City
Hoyerswerda
Country
Germany
Facility Name
Novartis Investigative site
City
Kaufbeuren
Country
Germany
Facility Name
Novartis Investigative site
City
Landsberg
Country
Germany
Facility Name
Novartis Investigative site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative site
City
Mainz
Country
Germany
Facility Name
Novartis Investigative site
City
Muenchen
Country
Germany
Facility Name
Novartis Investigative site
City
Oranienburg
Country
Germany
Facility Name
Novartis Investigative site
City
Oschersleben
Country
Germany
Facility Name
Novartis Investigative site
City
Potsdam
Country
Germany
Facility Name
Novartis Investigative site
City
Ratingen
Country
Germany
Facility Name
Novartis Investigative site
City
Steinfurt-Borghorst
Country
Germany
Facility Name
Novartis Investigator Site
City
Bangalore
Country
India
Facility Name
Novartis Investigative Site
City
Chennai
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
Country
India
Facility Name
Novartis Investigator Site
City
Coimbatore
Country
India
Facility Name
Novartis Investigator Site
City
Hyderabaad
Country
India
Facility Name
Novartis Investigator Site
City
Indore
Country
India
Facility Name
Novartis Investigator Site
City
Jaipur
Country
India
Facility Name
Novartis Investigator Site
City
Kolkata
Country
India
Facility Name
Novartis Investigator Site
City
Ludhiana
Country
India
Facility Name
Novartis Investigative Site
City
Mumbai
Country
India
Facility Name
Novartis Investigator Site
City
Panjim
Country
India
Facility Name
Novartis Investigator Site
City
Trivandrum
Country
India
Facility Name
Novartis Investigator Site
City
Bologna
Country
Italy
Facility Name
Novartis Investigator Site
City
Busto Arsizio
Country
Italy
Facility Name
Novartis Investigator Site
City
Catania
Country
Italy
Facility Name
Novartis Investigator Site
City
Catanzaro
Country
Italy
Facility Name
Novartis Investigator Site
City
Crema
Country
Italy
Facility Name
Novartis Investigator Site
City
Ferrara
Country
Italy
Facility Name
Novartis Investigator Site
City
Firenze
Country
Italy
Facility Name
Novartis Investigator Site
City
Messina
Country
Italy
Facility Name
Novartis Investigator Site
City
Milano
Country
Italy
Facility Name
Novartis Investigator Site
City
Pisa
Country
Italy
Facility Name
Novartis Investigator Site
City
Roma
Country
Italy
Facility Name
Novartis Investigator Site
City
Rozzano
Country
Italy
Facility Name
Novartis Investigator Site
City
Siena
Country
Italy
Facility Name
Novartis Investigator Site
City
Sottomarina
Country
Italy
Facility Name
Novartis Investigator Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigator Site
City
Alzira
Country
Spain
Facility Name
Novartis Investigator Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigator Site
City
Burgos
Country
Spain
Facility Name
Novartis Investigator Site
City
Cordoba
Country
Spain
Facility Name
Novartis Investigator Site
City
Girona
Country
Spain
Facility Name
Novartis Investigator Site
City
Gladakano
Country
Spain
Facility Name
Novartis Investigator Site
City
Jerez de Frontera
Country
Spain
Facility Name
Novartis Investigator Site
City
La Coruna
Country
Spain
Facility Name
Novartis Investigator Site
City
Las Palmas de Gran Canarias
Country
Spain
Facility Name
Novartis Investigator Site
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Novartis Investigator Site
City
Lugo
Country
Spain
Facility Name
Novartis Investigator Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigator Site
City
Malaga
Country
Spain
Facility Name
Novartis Investigator Site
City
Orense
Country
Spain
Facility Name
Novartis Investigator Site
City
Oviedo
Country
Spain
Facility Name
Novartis Investigator Site
City
Palma De Mallorca
Country
Spain
Facility Name
Novartis Investigator Site
City
Ponferrada
Country
Spain
Facility Name
Novartis Investigative Site
City
Pontevedra
Country
Spain
Facility Name
Novartis Investigator Site
City
Puerto de Sagunto
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
Country
Spain
Facility Name
Novartis Investigator Site
City
Valencia
Country
Spain
Facility Name
Novartis Investigator Site
City
Vic
Country
Spain
Facility Name
Novartis Investigator Site
City
Vila-real
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
Country
Spain
Facility Name
Novartis Investigative Site
City
Goteborg
Country
Sweden
Facility Name
Novartis Investigator Site
City
Jonkoping
Country
Sweden
Facility Name
Novartis Investigative Site
City
Lidingo
Country
Sweden
Facility Name
Novartis Investigative Site
City
Lulea
Country
Sweden
Facility Name
Novartis Investigator Site
City
Lulea
Country
Sweden
Facility Name
Novartis Investigator Site
City
Lund
Country
Sweden
Facility Name
Novartis Investigative Site
City
Kartal/Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Mersin
Country
Turkey
Facility Name
Novartis Investigator Site
City
Yenisehir/Izmir
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21349928
Citation
Chapman KR, Rennard SI, Dogra A, Owen R, Lassen C, Kramer B; INDORSE Study Investigators. Long-term safety and efficacy of indacaterol, a long-acting beta(2)-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest. 2011 Jul;140(1):68-75. doi: 10.1378/chest.10-1830. Epub 2011 Feb 24.
Results Reference
derived

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Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

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