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Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST1)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indacaterol 150 μg
Tiotropium 18 μg
Placebo to indacaterol
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 chronic obstructive pulmonary disease, COPD, indacaterol, tiotropium, bronchodilation

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and:

    1. Smoking history of at least 10 pack-years
    2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
    3. Post-bronchodilator FEV1/FVC (force vital capacity) < 70%

Exclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period
  • Patients with a body mass index less than 15 or more than 40 kg/m^2
  • 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 comorbid conditions

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

Sites / Locations

  • Novartis Investigator Site
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  • Novartis Investigative Site
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  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Center
  • Novartis Investigator Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SIte
  • Novartis Investigative Site
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  • Novartis Investigative Site
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  • Novartis Investigator Site
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  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
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  • Novartis Investigator Site
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  • Novartis Investigative Site
  • Novartis Investigator Site
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  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indacaterol 150 μg and tiotropium 18 μg

Tiotropium 18 μg

Arm Description

Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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 placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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 Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours 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, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Secondary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Full Information

First Posted
February 15, 2009
Last Updated
July 22, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00846586
Brief Title
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
Acronym
INTRUST1
Official Title
A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

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
chronic obstructive pulmonary disease, COPD, indacaterol, tiotropium, bronchodilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 150 μg and tiotropium 18 μg
Arm Type
Experimental
Arm Description
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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
Tiotropium 18 μg
Arm Type
Active Comparator
Arm Description
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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 was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Intervention Type
Drug
Intervention Name(s)
Tiotropium 18 μg
Intervention Description
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Intervention Type
Drug
Intervention Name(s)
Placebo to indacaterol
Intervention Description
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours 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, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame
From 5 minutes to 8 hours post-dose at the end of treatment (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 Treatment (Week 12 + 1 Day, Day 85)
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame
24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
Title
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame
From 5 minutes to 8 hours post-dose on Day 1
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame
24 hours post-dose on Day 2
Title
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame
From 5 minutes to 4 hours post-dose on Day 1
Title
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame
From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and: Smoking history of at least 10 pack-years Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value Post-bronchodilator FEV1/FVC (force vital capacity) < 70% Exclusion Criteria: Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period Patients with a body mass index less than 15 or more than 40 kg/m^2 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 comorbid conditions Other protocol-defined inclusion/exclusion criteria applied to the study.
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 Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
32509
Country
United States
Facility Name
Novartis Investigator Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Novartis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Novartis Investigator Site
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
Novartis Investigator Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Novartis Investigator Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Novartis Investigator Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Novartis Investigator Site
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
Novartis Investigative Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Novartis Investigator Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Novartis Investigative Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105-1208
Country
United States
Facility Name
Novartis Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Novartis Investigator Site
City
Ft. Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
331577
Country
United States
Facility Name
Novartis Investigative Site
City
Naranja
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Novartis Investigator Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Novartis Investigator Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Novartis Investigator Site
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
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
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Novartis Investigative Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Novartis Investigative Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novartis Investigator Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Novartis Investigator Site
City
Metaire
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Novartis Investigator Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Novartis Investigator Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Novartis Investigator Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Novartis Investigator Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Novartis Investigator Site
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Novartis Investigator Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Novartis Investigative Site
City
St Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Novartis Investigator Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Novartis Investigator Site
City
Boys Town
State/Province
Nebraska
ZIP/Postal Code
68010
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
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
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Novartis Investigator Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Novartis Investigator Site
City
Asbury Park
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Novartis Investigator Site
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
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 Investigator Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135-2920
Country
United States
Facility Name
Novartis Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Novartis Investigator Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
Country
United States
Facility Name
Novartis Investigative Site
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Novartis Investigator Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Novartis Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Novartis Investigator Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37919
Country
United States
Facility Name
Novartis Investigator Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Novartis Investigative Center
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130-6113
Country
United States
Facility Name
Novartis Investigator Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Novartis Investigator Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Novartis Investigative Site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
Country
Argentina
Facility Name
Novartis Investigative Site
City
Corrientes
Country
Argentina
Facility Name
Novartis Investigative SIte
City
Mendoza
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
Country
Argentina
Facility Name
Novartis Investigator Site
City
Box Hill
Country
Australia
Facility Name
Novartis Investigator Site
City
Clayton
Country
Australia
Facility Name
Novartis Investigator Site
City
Garran
Country
Australia
Facility Name
Novartis Investigator Site
City
Glebe
Country
Australia
Facility Name
Novartis Investigator Site
City
Kogarah
Country
Australia
Facility Name
Novartis Investigator Site
City
Nedlands
Country
Australia
Facility Name
Novartis Investigative Site
City
Barranquilla
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogota
Country
Colombia
Facility Name
Novartis Investigator Site
City
Bogota
Country
Colombia
Facility Name
Novartis Investigative Site
City
Medellin
Country
Colombia
Facility Name
Novartis Investigator Site
City
Copenhagen
Country
Denmark
Facility Name
Novartis Investigator Site
City
Fredericia
Country
Denmark
Facility Name
Novartis Investigator Site
City
Silkeborg
Country
Denmark
Facility Name
Novartis Investigator Site
City
Soeborg
Country
Denmark
Facility Name
Novartis Investigator Site
City
Vejle
Country
Denmark
Facility Name
Novartis Investigator Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigator Site
City
Cottbus
Country
Germany
Facility Name
Novartis Investigator Site
City
Donaustauf
Country
Germany
Facility Name
Novartis Investigator Site
City
Dortmund
Country
Germany
Facility Name
Novartis Investigator Site
City
Erfurt
Country
Germany
Facility Name
Novartis Investigator Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigator Site
City
Gelnhausen
Country
Germany
Facility Name
Novartis Investigator Site
City
Grosshansdorf
Country
Germany
Facility Name
Novartis Investigator Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigator Site
City
Heidelberg
Country
Germany
Facility Name
Novartis Investigator Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigator Site
City
Mainz
Country
Germany
Facility Name
Novartis Investigator Site
City
Neu-Ulm
Country
Germany
Facility Name
Novartis Investigator Site
City
Neuss
Country
Germany
Facility Name
Novartis Investigator Site
City
Potsdam
Country
Germany
Facility Name
Novartis Investigator Site
City
Rostock
Country
Germany
Facility Name
Novartis Investigator Site
City
Schwabach
Country
Germany
Facility Name
Novartis Investigator Site
City
Schwetzingen
Country
Germany
Facility Name
Novartis Investigator Site
City
Straussberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
Country
Germany
Facility Name
Novartis Investigator Site
City
Wuppertal
Country
Germany
Facility Name
Novartis Investigative Site
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guadalajara
Country
Mexico
Facility Name
Novartis Investigator Site
City
Mexico City
Country
Mexico
Facility Name
Novartis Investigative Site
City
Monterrey
Country
Mexico
Facility Name
Novartis Investigative Site
City
Zapopan
Country
Mexico
Facility Name
Novartis Investigator Site
City
Manila
Country
Philippines
Facility Name
Novartis Investigator Site
City
Amanzimtoti
Country
South Africa
Facility Name
Novartis Investigator Site
City
Cape Town
Country
South Africa
Facility Name
Novartis Investigator Site
City
Johannesburg
Country
South Africa
Facility Name
Novartis Investigator Site
City
Midrand
Country
South Africa
Facility Name
Novartis Investigator Site
City
Umkomaas
Country
South Africa
Facility Name
Novartis Investigative Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigator Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigator Site
City
Begonte
Country
Spain
Facility Name
Novartis Investigator Site
City
Cadiz
Country
Spain
Facility Name
Novartis Investigator Site
City
Granollers
Country
Spain
Facility Name
Novartis Investigative Site
City
Jaén
Country
Spain
Facility Name
Novartis Investigator Site
City
La Coruna
Country
Spain
Facility Name
Novartis Investigator Site
City
Leon
Country
Spain
Facility Name
Novartis Investigator Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigator Site
City
Pamplona
Country
Spain
Facility Name
Novartis Investigator Site
City
Torrelavega
Country
Spain
Facility Name
Novartis Investigator Site
City
Valencia
Country
Spain
Facility Name
Novartis Investigator Site
City
Vigo
Country
Spain
Facility Name
Novartis Investigator Site
City
Antalya
Country
Turkey
Facility Name
Novartis Investigator Site
City
Canakkale
Country
Turkey
Facility Name
Novartis Investigator Site
City
Isparta
Country
Turkey
Facility Name
Novartis Investigator Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Kartal
Country
Turkey
Facility Name
Novartis Investigator Site
City
Kayseri
Country
Turkey
Facility Name
Novartis Investigator Site
City
Kozlu / Zonguldak
Country
Turkey
Facility Name
Novartis Investigator Site
City
Malatya
Country
Turkey
Facility Name
Novartis Investigator Site
City
Manisa
Country
Turkey
Facility Name
Novartis Investigator Site
City
Mecidiyekoy/Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Yenisehir/Izmir
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22544891
Citation
Mahler DA, D'Urzo A, Bateman ED, Ozkan SA, White T, Peckitt C, Lassen C, Kramer B; INTRUST-1 and INTRUST-2 study investigators. Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomised, double-blind comparison. Thorax. 2012 Sep;67(9):781-8. doi: 10.1136/thoraxjnl-2011-201140. Epub 2012 Apr 27.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

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