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A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) (INTENSITY)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indacaterol 150 μg
Tiotropium 18 μg
Placebo to indacaterol
Placebo to tiotropium
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 focused on measuring COPD, indacaterol, beta 2 agonist, tiotropium

Eligibility Criteria

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

Inclusion Criteria:

- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

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

Exclusion Criteria:

  • Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
  • 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
  • Patients with a history of certain cardiovascular comorbid conditions

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

Sites / Locations

  • 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

Tiotropium 18 µg

Arm Description

Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.

Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.

Secondary Outcome Measures

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning & psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment
A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.

Full Information

First Posted
May 12, 2009
Last Updated
July 22, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00900731
Brief Title
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
INTENSITY
Official Title
A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 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

5. Study Description

Brief Summary
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, indacaterol, beta 2 agonist, tiotropium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1598 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 150 µg
Arm Type
Experimental
Arm Description
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Arm Title
Tiotropium 18 µg
Arm Type
Active Comparator
Arm Description
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
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)
Tiotropium 18 μg
Intervention Description
Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
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 tiotropium
Intervention Description
Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)
Description
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
End of treatment (Week 12)
Secondary 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 4 Hours Post-dose at the End of Treatment (Week 12)
Description
Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
5 minutes to 4 hours post-dose at the end of treatment (week 12)
Title
Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment
Description
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
12 weeks
Title
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Description
SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning & psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
12 weeks
Title
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Description
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
Baseline, up to 12 weeks
Title
Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Description
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
Baseline, up to 12 weeks
Title
Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Description
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
Baseline, up to 12 weeks
Title
Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment
Description
A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and: a) Smoking history of at least 10 pack-years b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value c) Post-bronchodilator FEV1/FVC (forced vital capacity) < 70% Exclusion Criteria: Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening 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 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 Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Novartis Investigator 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
85050
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
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novartis Investigator Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Novartis Investigator Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novartis Investigator Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Novartis Investigator Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Novartis Investigative Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Novartis Investigator Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Novartis Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
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
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Novartis Investigative Center
City
St Charles
State/Province
Missouri
ZIP/Postal Code
63301
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
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
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
Albany
State/Province
New York
ZIP/Postal Code
12205
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
New York
State/Province
New York
ZIP/Postal Code
10016
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
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
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
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Novartis Investigator Site
City
Feldbach
Country
Austria
Facility Name
Novartis Investigator Site
City
Gänserndorf
Country
Austria
Facility Name
Novartis Investigator Site
City
Hallein
Country
Austria
Facility Name
Novartis Investigator Site
City
Bruxelles
Country
Belgium
Facility Name
Novartis Investigator Site
City
Gilly
Country
Belgium
Facility Name
Novartis Investigator Site
City
Jambes
Country
Belgium
Facility Name
Novartis Investigator Site
City
Jette
Country
Belgium
Facility Name
Novartis Investigator Site
City
Liège
Country
Belgium
Facility Name
Novartis Investigator Site
City
Montigny-le-tilleul
Country
Belgium
Facility Name
Novartis Investigator Site
City
Oostende
Country
Belgium
Facility Name
Novartis Investigator Site
City
Saint Vith
Country
Belgium
Facility Name
Novartis Investigator Site
City
Yvoir
Country
Belgium
Facility Name
Novartis Investigator Site
City
Calgary
Country
Canada
Facility Name
Novartis Investigative Site
City
Mississauga
Country
Canada
Facility Name
Novartis Investigative Site
City
Moncton
Country
Canada
Facility Name
Novartis Investigative Site
City
New Market
Country
Canada
Facility Name
Novartis Investigative SIte
City
Quebec
Country
Canada
Facility Name
Novartis Investigative Site
City
St-Romuald
Country
Canada
Facility Name
Novartis Investigative Site
City
Sudbury
Country
Canada
Facility Name
Novartis Investigator Site
City
Barranquilla
Country
Colombia
Facility Name
Novartis Investigator Site
City
Bogota
Country
Colombia
Facility Name
Novartis Investigator Site
City
Medellin
Country
Colombia
Facility Name
Novartis Investigator Site
City
Aalborg
Country
Denmark
Facility Name
Novartis Investigator Site
City
Frederiksberg
Country
Denmark
Facility Name
Novartis Investigator Site
City
Næstved
Country
Denmark
Facility Name
Novartis Investigator Site
City
Roskilde
Country
Denmark
Facility Name
Novartis Investigator Site
City
Sønderborg
Country
Denmark
Facility Name
Novartis Investigator Site
City
Vaerlose
Country
Denmark
Facility Name
Novartis Investigator Site
City
Viborg
Country
Denmark
Facility Name
Novartis Investigator Site
City
Helsinki
Country
Finland
Facility Name
Novartis Investigator Site
City
Jyväskylä
Country
Finland
Facility Name
Novartis Investigator Site
City
Lahti
Country
Finland
Facility Name
Novartis Investigator Site
City
OYS
Country
Finland
Facility Name
Novartis Investigator Site
City
Pori
Country
Finland
Facility Name
Novartis Investigator Site
City
Turku
Country
Finland
Facility Name
Novartis Investigative Site
City
Ambroise
Country
France
Facility Name
Novartis Investigative Site
City
Antibes
Country
France
Facility Name
Novartis Investigator Site
City
Beuvry
Country
France
Facility Name
Novartis Investigator Site
City
Ferolles-Attily
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
Country
France
Facility Name
Novartis Investigator Site
City
Nantes
Country
France
Facility Name
Novartis Investigative Site
City
Nice
Country
France
Facility Name
Novartis Investigative Site
City
Nimes
Country
France
Facility Name
Novartis Investigative Site
City
Paris
Country
France
Facility Name
Novartis Investigator Site
City
Paris
Country
France
Facility Name
Novartis Investigative Site
City
Pessac
Country
France
Facility Name
Novartis Investigator Site
City
Pierre Benite
Country
France
Facility Name
Novartis Investigative Site
City
Suresnes
Country
France
Facility Name
Novartis Investigator Site
City
Vandoeuvre Les Nancys
Country
France
Facility Name
Novartis Investigator Site
City
Bergisch Gladbach
Country
Germany
Facility Name
Novartis Investigator Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigator Site
City
Bochum
Country
Germany
Facility Name
Novartis Investigator Site
City
Bonn
Country
Germany
Facility Name
Novartis Investigator Site
City
Buchholz
Country
Germany
Facility Name
Novartis Investigator Site
City
Coburg
Country
Germany
Facility Name
Novartis Investigator Site
City
Dueren
Country
Germany
Facility Name
Novartis Investigator Site
City
Eggenfelden
Country
Germany
Facility Name
Novartis Investigator Site
City
Eschwege
Country
Germany
Facility Name
Novartis Investigator Site
City
Euskirchen
Country
Germany
Facility Name
Novartis Investigator Site
City
Freudenberg
Country
Germany
Facility Name
Novartis Investigator Site
City
Fürth
Country
Germany
Facility Name
Novartis Investigator Site
City
Gelsenkirchen
Country
Germany
Facility Name
Novartis Investigator Site
City
Gummersbach
Country
Germany
Facility Name
Novartis Investigator Site
City
Hagen
Country
Germany
Facility Name
Novartis Investigator Site
City
Halle
Country
Germany
Facility Name
Novartis Investigator Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigator Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigator Site
City
Hoyerswerda
Country
Germany
Facility Name
Novartis Investigator Site
City
Kassel
Country
Germany
Facility Name
Novartis Investigative Site
City
Landsberg
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
Munich
Country
Germany
Facility Name
Novartis Investigator Site
City
Oranienburg
Country
Germany
Facility Name
Novartis Investigator Site
City
Radebeul
Country
Germany
Facility Name
Novartis Investigator Site
City
Ratingen
Country
Germany
Facility Name
Novartis Investigator Site
City
Ruhmannsfelden
Country
Germany
Facility Name
Novartis Investigator Site
City
Rüsselsheim
Country
Germany
Facility Name
Novartis Investigator Site
City
Solingen
Country
Germany
Facility Name
Novartis Investigator Site
City
Stockach
Country
Germany
Facility Name
Novartis Investigator Site
City
Teterow
Country
Germany
Facility Name
Novartis Investigator Site
City
Vilshofen
Country
Germany
Facility Name
Novartis Investigator Site
City
Wallerfing
Country
Germany
Facility Name
Novartis Investigator Site
City
Wissen
Country
Germany
Facility Name
Novartis Investigator Site
City
Athens
Country
Greece
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigator Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigator Site
City
Debrecen
Country
Hungary
Facility Name
Novartis Investigative Site
City
Farkasgyepu
Country
Hungary
Facility Name
Novartis Investigative Site
City
Godollo
Country
Hungary
Facility Name
Novartis Investigator Site
City
Szolnok
Country
Hungary
Facility Name
Novartis Investigator Site
City
Haifa
Country
Israel
Facility Name
Novartis Investigator Site
City
Petach-Tikva
Country
Israel
Facility Name
Novartis Investigator Site
City
Ancona
Country
Italy
Facility Name
Novartis Investigator Site
City
Foggia
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
Country
Italy
Facility Name
Novartis Investigator Site
City
Milano
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
Country
Italy
Facility Name
Novartis Investigator Site
City
Pavia
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
Country
Italy
Facility Name
Novartis Investigator Site
City
Pisa
Country
Italy
Facility Name
Novartis Investigative Site
City
Huxquilucan
Country
Mexico
Facility Name
Novartis Investigator Site
City
Mexico City
Country
Mexico
Facility Name
Novartis Investigative Site
City
San Luis Potosi
Country
Mexico
Facility Name
Novartis Investigator Site
City
Drammen
Country
Norway
Facility Name
Novartis Investigator Site
City
Follebu
Country
Norway
Facility Name
Novartis Investigative Site
City
Kongsberg
Country
Norway
Facility Name
Novartis Investigator Site
City
Kongsberg
Country
Norway
Facility Name
Novartis Investigator Site
City
Kongsvinger
Country
Norway
Facility Name
Novartis Investigator Site
City
Lierskogen
Country
Norway
Facility Name
Novartis Investigative Site
City
Oslo
Country
Norway
Facility Name
Novartis Investigator Site
City
Oslo
Country
Norway
Facility Name
Novartis Investigator Site
City
Sandvika
Country
Norway
Facility Name
Novartis Investigative Site
City
Skedsmokorset
Country
Norway
Facility Name
Novartis Investigator Site
City
Stavanger
Country
Norway
Facility Name
Novartis Investigative Site
City
Trondheim
Country
Norway
Facility Name
Novartis Investigator Site
City
Trondheim
Country
Norway
Facility Name
Novartis Investigative Site
City
Ålesund
Country
Norway
Facility Name
Novartis Investigator Site
City
Ålesund
Country
Norway
Facility Name
Novartis Investigator Site
City
Gdansk
Country
Poland
Facility Name
Novartis Investigator Site
City
Katowice
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
Country
Poland
Facility Name
Novartis Investigator Site
City
Krakow
Country
Poland
Facility Name
Novartis Investigator Site
City
Piekary Slaskie
Country
Poland
Facility Name
Novartis Investigator Site
City
Warszawa
Country
Poland
Facility Name
Novartis Investigator Site
City
Wroclaw
Country
Poland
Facility Name
Novartis Investigator Site
City
Barnaul
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Kazan
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Petrozavodsk
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Ryazan
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Samara
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Bratislava
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Kosice
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Kralovsky Chlmec
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Nitra
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Presov
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Zvolen
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Alcorcón
Country
Spain
Facility Name
Novartis Investigator Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigator Site
City
Badalona
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
Begonte
Country
Spain
Facility Name
Novartis Investigator Site
City
Burgos
Country
Spain
Facility Name
Novartis Investigator Site
City
Caceres
Country
Spain
Facility Name
Novartis Investigator Site
City
Canet de Mar
Country
Spain
Facility Name
Novartis Investigative Site
City
Fuenlabrada
Country
Spain
Facility Name
Novartis Investigative Site
City
Girona
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigator Site
City
Mataro
Country
Spain
Facility Name
Novartis Investigator Site
City
Plasencia
Country
Spain
Facility Name
Novartis Investigative Site
City
Ponferrada
Country
Spain
Facility Name
Novartis Investigative Site
City
Pontevedra
Country
Spain
Facility Name
Novartis Investigator Site
City
Prat de Llobregat
Country
Spain
Facility Name
Novartis Investigative Site
City
Santander
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
Country
Spain
Facility Name
Novartis Investigative Site
City
Vila-real
Country
Spain
Facility Name
Novartis Investigator Site
City
Basel
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Bellinzona
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Lugano
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Muenchenstein
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Zuerich
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Altunizade
Country
Turkey
Facility Name
Novartis Investigator Site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Aydin
Country
Turkey
Facility Name
Novartis Investigator Site
City
Büyükçekmece / Ýstanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Fatih / Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Kahramanmaras
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mecidiyekoy/Istanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mersin
Country
Turkey
Facility Name
Novartis Investigative Site
City
Soke / Aydin
Country
Turkey
Facility Name
Novartis Investigative Site
City
Yenisehir/Izmir
Country
Turkey
Facility Name
Novartis Investigator Site
City
Ash Vale
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Ashford
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Bolton
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Boscastle
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Bradford
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Chertsey
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
East Horsley
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Newcastle-upon-Tyne
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Plymouth
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Watford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21622587
Citation
Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B; INTENSITY study investigators. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011 Oct;38(4):797-803. doi: 10.1183/09031936.00191810. Epub 2011 May 26.
Results Reference
derived

Learn more about this trial

A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

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