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26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Indacaterol
Formoterol (12 µg b.i.d.)
Tiotropium (18 µg o.d.)
Placebo to Indacaterol
Placebo to Formoterol
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring indacaterol, long acting beta-2 agonist

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure

  • Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:

    • Smoking history of at least 20 pack years
    • Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value.
    • Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

Exclusion Criteria:

  • Pregnant or lactating females
  • Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
  • Patients requiring long term oxygen therapy (> 15 h a day)
  • Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
  • Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
  • Patients with a history of asthma (with further criteria)
  • Patients with Type I or uncontrolled Type II diabetes
  • Patients with contraindications for tiotropium
  • Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
  • Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
  • Patients with a history of long QT syndrome or whose QTc interval is prolonged
  • Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
  • Patients who have had treatment with the investigational drug (with further criteria)
  • Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period
  • Patients with known history of non compliance to medication
  • Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Pinnacle Research Group, LLC
  • University of Alabama at Birmingham
  • Pulmonary Medicine Associates PC
  • Jasper Summit Research
  • Pulmonary Associate of Mobile, PC
  • Pulmonary Associates, PA
  • Pulmonary Associates, PA
  • Novartis Investigative Center
  • Arizona Pulmonary Specialists, LTD
  • Premiere Pharmaceutical Research, LLC
  • Canyon Clinical Research, LLC
  • SAVAHSC / Pulmonary Section
  • Novartis Investigator Site
  • Novartis Investigator Site
  • USC Rancho Amigos Medical Center
  • Encompass Clinical Research - North Coast
  • California Research
  • Allergy and Asthma Specialists Medical Group and research Center
  • Interlink Research Institute
  • Allergy Research Foundation, Inc
  • Novartis Investigator Site
  • Southern California Institute for Respiratory Diseases
  • David Geffen UCLA School of Medicine
  • Advance Clinical Research Institute
  • California Allergy & Asthma Medical Group
  • Intergrated Research Group
  • Allergy & Asthma Associates of Santa Clara Res. Center
  • Greater Los Angeles Healthcare System
  • Encompass Clinical Research
  • Bensch Clinical Research Associates
  • Peninsula Pulmonary Medical Associates
  • Progressive Clinical Research
  • Allergy and Asthma Clinical Research Inc
  • Boulder Medical Center
  • National Jewish Medical & Research Center
  • Northern Colorado Pulmonary Consultants, PC
  • New West Physicians Clinical research
  • Rocky Mountain Center for Clinical Research
  • Western States Clinical Research
  • Norwalk Hospital
  • Lung Health & Sleep Enhancement Center
  • Clinical Research of West Florida
  • University of Florida Shands Hospital
  • Shands Jacksonville Medical Center
  • Innovative Research of West Florida
  • University of Miami School of Medicine
  • Elite Research Institute
  • Novartis Investigator Site
  • Emerald Coast Clinical Research, LLC
  • Pensacola Research Consultants
  • Integrity Research
  • Brevard Pulmonary Specialists
  • Asthma & Allergy Research Center
  • South Miami Clinical Research, LLC
  • Central Medical Group, PA
  • Clireco, Inc
  • Novartis Investigator Site
  • University of South Florida
  • Neutrotrials Research Inc
  • Georgia Clinical Research
  • Marietta Pulmonary Medicine
  • University of Chicago Hospital
  • Sneeze, Wheeze & Itch Associates, LLC
  • Southern Illinois Clinical Research Center
  • Novartis Investigator Site
  • Community Hospital Anderson
  • Dawes Fretzin Clinical Research Group LLC
  • South Bend Clinic
  • Iowa Clinical Research Corporation
  • University of Iowa
  • Heart of America Research Institute
  • Cotton-O'Neil Clinical Research Center
  • Novartis Investigator Site
  • Kentucky Medical research Center
  • University of Kentucky Chandler Medical Center
  • Family Asthma and Allergy Research Associates
  • Gulf Coast Research, LLC
  • Rx R&D
  • LSU Health Sciences Center/LSU School of Medicine
  • New Orleans Center for Clinical Research
  • Louisiana Health Sciences Center
  • Northshore Research Associates
  • Allergy, Asthma, Immunology, Pharmaceutical Studies
  • Primecare Physician Associates
  • John Hopkins Asthma and Allergy Center
  • Miray Medical Center
  • Fallon Clinic at Worcester Medical Center
  • ClinSite, Inc
  • Novartis Investigator Site
  • Harper University Hospital; Wayne State University
  • Novartis Investigator Site
  • Pulmonary Respiratory Institute of Southwest Michigan
  • Novartis Investigator Site
  • Synergy Medical Education Alliance
  • Novartis Investigator Site
  • Minnesota Lung Center
  • Clinical Research Institute
  • Novartis Investigator Site
  • Minnesota Lung Center
  • Mayo Clinic
  • St. Luke's Cardio-Pulmonary Research
  • University of Missouri - Columbia
  • Kansas City University of Medicine and Biosciences
  • University of Missouri KC/ Truman Medical
  • The Clinical Research Centre
  • Midwest Chest Consultants
  • Washington U School of Medicine, Center for Clinical Studies
  • Montana Health Research Institute
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Somnos Laboratories, Inc
  • Omaha VA Medical Center
  • Quality Clinical Research
  • Midwest Allergy and Asthma Clinic
  • Creighton University Centre for Allergy, Asthma & Immunology
  • Creigton University
  • Heartland Clinical Research, Inc
  • Meridian Clinical Research, LLC
  • University of Nebraska Medical Center - Pulmonary Research
  • The Asthma & Allergy Center, PC
  • Lovelace Scientific Resources, Inc.
  • Clinical Research Center of NV
  • Dartmouth Hitchcock Medical Center
  • Delaware Valley Clinical Research
  • Pulmonary and Critical Care Associates, PA
  • Novartis Investigator Site
  • Pulmonary and Allergy Associates, PA
  • Pulmonary and Critical Care Services
  • Crescent Medical Associates
  • Asthma and Allergy Associates
  • Asthma and Allergy Associates
  • Nassau Chest Physicians, PC
  • North Shore University Hospital
  • New York Pulmonary Associates, PC
  • Weill Medical College of Cornell University
  • Mount Sinai Medical Center
  • AAIR research Centre
  • University of North Carolina
  • Sensenbrenner Primary Care
  • North Carolina Clinical Research
  • Novartis Investigator Site
  • Cloverdale Research Facility
  • Merit Care Medical Group
  • Cincinnati VA Hospital
  • New Horizons Clinical Research
  • Bernstein Clinical Research Centre
  • Community Research Inc
  • University Hospitals of Cleveland
  • Metro Health Medical Center
  • Cleveland Clinic
  • Ohio State University - Davis Heart and Lung Research Institute
  • Novartis Investigator Site
  • Remington-Davis Clinical Research
  • Novartis Investigator Site
  • Novartis Investigator Site
  • John Winder Associates
  • Advanced Health Care Specialists
  • The University of Toledo
  • Pharmacotherapy Research Associates, Inc
  • Oklahoma Allergy and Asthma Clinic
  • University of Oklahoma Health Science Center
  • Lynne Health Science Institute
  • Healthcare Research Consultants, Inc
  • River Road Medical Group
  • Clinical Research Institute of Southern Oregon, PC
  • Oregon Clinical Research Associates
  • Allergy Associates Research Center
  • Novartis Investigator Site
  • Tri-State Medical Group
  • Novartis Investigator Site
  • Chest Diseases of Northwestern PA
  • Asthma Allergy &Pulmonary Associates, PC
  • Drexel University College of Medicine
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Pittsburgh Pulmonary Associates
  • South Hills Pulmonary Associates
  • New England Center for Clinical Research
  • Partners in Clinical Research
  • Low County Lung and Critical Care, PA
  • Hugh D. Durrence, MD, Family Medicine
  • Medical University of South Carolina
  • Med Plus South - Strand Family Practice
  • Novartis Investigator Site
  • Spartanburg Pharmaceutical Research
  • Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab
  • MultiSpeciality Clinical Research
  • Holston Medical Group
  • Volunteer Research Center
  • Dickson Family Medicine Group, PC
  • Novartis Investigator Site
  • Heartland Medical, P.C
  • PharmaTex Research LLC
  • Trinity Clinic - Corsicana
  • Pharmaceutical Research & Consulting, Inc
  • Asthma & Allergy Research Associates
  • Western Sky Medical Research
  • Texas Pulmonary & Critical Care
  • University of Texas Medical Branch at Galveston
  • *Private Practice*
  • Baylor College of Medicine
  • Houstons Veteran's Medical Center
  • West Houston Allergy and Asthma, PA
  • Central Texas Health Research
  • Quality Assurance Research Centre
  • Audie L. Murphy VA Hospital
  • Allergy and Asthma Research Center, PA
  • Diagnostics Research Group
  • Wellmed Clinical Research
  • Vermont Lung Center
  • Johnston Memorial Hospital Pulmonary Research
  • University of Virginia
  • Lynchburg Pulmonary Associates
  • Novartis Investigator Site
  • Madrona Medical Group - Clinical Research Dept.
  • Pulmonary and Research Associates
  • William L. Gray Research
  • Pulmonary Consultants, PLLC
  • Madigan Army medical Center / Dept. of Army
  • Charleston Area Medical Center
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis
  • Novartis Investigator Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Experimental

Experimental

Active Comparator

Arm Label

Indacaterol 150 µg (Continued Into Stage 2)

Indacaterol 300 µg (Continued Into Stage 2)

Tiotropium 18 µg (Continued Into Stage 2)

Placebo (Continued Into Stage 2)

Indacaterol 75 µg (Not Continued into Stage 2)

Indacaterol 600 µg (Not Continued Into Stage 2)

Formoterol 12 µg (Not Continued Into Stage 2)

Arm Description

In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.

Secondary Outcome Measures

The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period
A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of "days of poor control" as well as FEV1 reversibility components as covariates.

Full Information

First Posted
April 19, 2007
Last Updated
July 22, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00463567
Brief Title
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive
Keywords
indacaterol, long acting beta-2 agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2059 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 150 µg (Continued Into Stage 2)
Arm Type
Experimental
Arm Description
In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Arm Title
Indacaterol 300 µg (Continued Into Stage 2)
Arm Type
Experimental
Arm Description
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Arm Title
Tiotropium 18 µg (Continued Into Stage 2)
Arm Type
Active Comparator
Arm Description
Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Arm Title
Placebo (Continued Into Stage 2)
Arm Type
Placebo Comparator
Arm Description
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Arm Title
Indacaterol 75 µg (Not Continued into Stage 2)
Arm Type
Experimental
Arm Description
In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Arm Title
Indacaterol 600 µg (Not Continued Into Stage 2)
Arm Type
Experimental
Arm Description
In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Arm Title
Formoterol 12 µg (Not Continued Into Stage 2)
Arm Type
Active Comparator
Arm Description
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Formoterol (12 µg b.i.d.)
Intervention Description
Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.
Intervention Type
Drug
Intervention Name(s)
Tiotropium (18 µg o.d.)
Intervention Description
Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
Intervention Type
Drug
Intervention Name(s)
Placebo to Indacaterol
Intervention Description
In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Placebo to Formoterol
Intervention Description
In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period
Description
A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of "days of poor control" as well as FEV1 reversibility components as covariates.
Time Frame
up to 26 weeks
Other Pre-specified Outcome Measures:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment
Description
Interim Analysis: Stage 1. Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.
Time Frame
Day 15, After 2 Weeks of treatment in Stage 1
Title
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment
Description
Interim Analysis: Stage 1. Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.
Time Frame
Day 14, After 2 Weeks of treatment in Stage 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and: Smoking history of at least 20 pack years Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value. Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol) Exclusion Criteria: Pregnant or lactating females Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period Patients requiring long term oxygen therapy (> 15 h a day) Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria) Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis Patients with a history of asthma (with further criteria) Patients with Type I or uncontrolled Type II diabetes Patients with contraindications for tiotropium Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality Any patient with active cancer or a history of cancer with less than 5 years disease free survival time Patients with a history of long QT syndrome or whose QTc interval is prolonged Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures Patients who have had treatment with the investigational drug (with further criteria) Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period Patients with known history of non compliance to medication Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements 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 Chair
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Pulmonary Medicine Associates PC
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Jasper Summit Research
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Pulmonary Associate of Mobile, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Pulmonary Associates, PA
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Pulmonary Associates, PA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Novartis Investigative Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Arizona Pulmonary Specialists, LTD
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Premiere Pharmaceutical Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Canyon Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
SAVAHSC / Pulmonary Section
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
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
USC Rancho Amigos Medical Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Encompass Clinical Research - North Coast
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
California Research
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Allergy and Asthma Specialists Medical Group and research Center
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Interlink Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Allergy Research Foundation, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Novartis Investigator Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Southern California Institute for Respiratory Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
David Geffen UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Advance Clinical Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
California Allergy & Asthma Medical Group
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
Intergrated Research Group
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Allergy & Asthma Associates of Santa Clara Res. Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Greater Los Angeles Healthcare System
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Bensch Clinical Research Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Peninsula Pulmonary Medical Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Progressive Clinical Research
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Allergy and Asthma Clinical Research Inc
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Boulder Medical Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
National Jewish Medical & Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Northern Colorado Pulmonary Consultants, PC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
New West Physicians Clinical research
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Rocky Mountain Center for Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Western States Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Lung Health & Sleep Enhancement Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University of Florida Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610 - 0277
Country
United States
Facility Name
Shands Jacksonville Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Innovative Research of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Elite Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Novartis Investigator Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Emerald Coast Clinical Research, LLC
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Pensacola Research Consultants
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Integrity Research
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Brevard Pulmonary Specialists
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Asthma & Allergy Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
South Miami Clinical Research, LLC
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Central Medical Group, PA
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Clireco, Inc
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Novartis Investigator Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Neutrotrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Georgia Clinical Research
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Marietta Pulmonary Medicine
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sneeze, Wheeze & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Southern Illinois Clinical Research Center
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Novartis Investigator Site
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Community Hospital Anderson
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Iowa Clinical Research Corporation
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Heart of America Research Institute
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novartis Investigator Site
City
Crescent Springs
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Kentucky Medical research Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Family Asthma and Allergy Research Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Gulf Coast Research, LLC
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Rx R&D
City
Metaire
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
LSU Health Sciences Center/LSU School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Louisiana Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Northshore Research Associates
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461
Country
United States
Facility Name
Allergy, Asthma, Immunology, Pharmaceutical Studies
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Primecare Physician Associates
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
John Hopkins Asthma and Allergy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Miray Medical Center
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Fallon Clinic at Worcester Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01604
Country
United States
Facility Name
ClinSite, Inc
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0525
Country
United States
Facility Name
Novartis Investigator Site
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Harper University Hospital; Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Novartis Investigator Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Pulmonary Respiratory Institute of Southwest Michigan
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Novartis Investigator Site
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Synergy Medical Education Alliance
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602 - 5303
Country
United States
Facility Name
Novartis Investigator Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Novartis Investigator Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Minnesota Lung Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Cardio-Pulmonary Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Kansas City University of Medicine and Biosciences
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64106 - 1453
Country
United States
Facility Name
University of Missouri KC/ Truman Medical
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108-2677
Country
United States
Facility Name
The Clinical Research Centre
City
St, Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Midwest Chest Consultants
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Washington U School of Medicine, Center for Clinical Studies
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montana Health Research Institute
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Novartis Investigator Site
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Novartis Investigator Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Somnos Laboratories, Inc
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Omaha VA Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Midwest Allergy and Asthma Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Creighton University Centre for Allergy, Asthma & Immunology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Creigton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Heartland Clinical Research, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
University of Nebraska Medical Center - Pulmonary Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198 - 5885
Country
United States
Facility Name
The Asthma & Allergy Center, PC
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Clinical Research Center of NV
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89131
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Delaware Valley Clinical Research
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Pulmonary and Critical Care Associates, PA
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Novartis Investigator Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
7101
Country
United States
Facility Name
Pulmonary and Allergy Associates, PA
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Pulmonary and Critical Care Services
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Crescent Medical Associates
City
Astoria
State/Province
New York
ZIP/Postal Code
11102
Country
United States
Facility Name
Asthma and Allergy Associates
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Asthma and Allergy Associates
City
Elmira
State/Province
New York
ZIP/Postal Code
14905
Country
United States
Facility Name
Nassau Chest Physicians, PC
City
Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
North Shore University Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
New York Pulmonary Associates, PC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
AAIR research Centre
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Sensenbrenner Primary Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Novartis Investigator Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Cloverdale Research Facility
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Merit Care Medical Group
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Cincinnati VA Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452242
Country
United States
Facility Name
Bernstein Clinical Research Centre
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Community Research Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Metro Health Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University - Davis Heart and Lung Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Novartis Investigator Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Remington-Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Novartis Investigator Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Novartis Investigator Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
John Winder Associates
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43650
Country
United States
Facility Name
Advanced Health Care Specialists
City
Thornville
State/Province
Ohio
ZIP/Postal Code
43076
Country
United States
Facility Name
The University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Pharmacotherapy Research Associates, Inc
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Oklahoma Allergy and Asthma Clinic
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynne Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Healthcare Research Consultants, Inc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
River Road Medical Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Oregon Clinical Research Associates
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy Associates Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Novartis Investigator Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1110
Country
United States
Facility Name
Tri-State Medical Group
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009 - 1957
Country
United States
Facility Name
Novartis Investigator Site
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Chest Diseases of Northwestern PA
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Asthma Allergy &Pulmonary Associates, PC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Novartis Investigator Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Novartis Investigator Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Pittsburgh Pulmonary Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
South Hills Pulmonary Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
New England Center for Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Partners in Clinical Research
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Low County Lung and Critical Care, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406-7108
Country
United States
Facility Name
Hugh D. Durrence, MD, Family Medicine
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Med Plus South - Strand Family Practice
City
Garden City
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Novartis Investigator Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Spartanburg Pharmaceutical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab
City
Varnville
State/Province
South Carolina
ZIP/Postal Code
29944
Country
United States
Facility Name
MultiSpeciality Clinical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Volunteer Research Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Dickson Family Medicine Group, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Novartis Investigator Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208-3599
Country
United States
Facility Name
Heartland Medical, P.C
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825-1409
Country
United States
Facility Name
PharmaTex Research LLC
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Trinity Clinic - Corsicana
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Pharmaceutical Research & Consulting, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4307
Country
United States
Facility Name
Asthma & Allergy Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Western Sky Medical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Texas Pulmonary & Critical Care
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555 - 0561
Country
United States
Facility Name
*Private Practice*
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houstons Veteran's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
West Houston Allergy and Asthma, PA
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Quality Assurance Research Centre
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Audie L. Murphy VA Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229 - 4404
Country
United States
Facility Name
Allergy and Asthma Research Center, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Wellmed Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Vermont Lung Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
Johnston Memorial Hospital Pulmonary Research
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Lynchburg Pulmonary Associates
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Novartis Investigator Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Madrona Medical Group - Clinical Research Dept.
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98226
Country
United States
Facility Name
Pulmonary and Research Associates
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
William L. Gray Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Pulmonary Consultants, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Madigan Army medical Center / Dept. of Army
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
26304
Country
United States
Facility Name
Novartis Investigator Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Novartis Investigator Site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigator Site
City
Capital Federal
Country
Argentina
Facility Name
Novartis Investigator Site
City
Santa Fe
Country
Argentina
Facility Name
Novartis Investigator Site
City
Ajax
Country
Canada
Facility Name
Novartis Investigator Site
City
Calgary
Country
Canada
Facility Name
Novartis Investigator Site
City
Chatham
Country
Canada
Facility Name
Novartis Investigator Site
City
Gatineau
Country
Canada
Facility Name
Novartis Investigator Site
City
Moncton
Country
Canada
Facility Name
Novartis Investigator Site
City
Montreal
Country
Canada
Facility Name
Novartis Investigator Site
City
Niagara Falls
Country
Canada
Facility Name
Novartis Investigator Site
City
Ottawa
Country
Canada
Facility Name
Novartis
City
Quebec
Country
Canada
Facility Name
Novartis Investigator Site
City
Saskatoon
Country
Canada
Facility Name
Novartis Investigator Site
City
Sherbrooke
Country
Canada
Facility Name
Novartis Investigator Site
City
St John's
Country
Canada
Facility Name
Novartis Investigator Site
City
St John
Country
Canada
Facility Name
Novartis Investigator Site
City
St Romuald
Country
Canada
Facility Name
Novartis Investigator Site
City
Ste-Foy
Country
Canada
Facility Name
Novartis Investigator Site
City
Toronto
Country
Canada
Facility Name
Novartis Investigator Site
City
Trois-Rivieres
Country
Canada
Facility Name
Novartis Investigator Site
City
Vancouver
Country
Canada
Facility Name
Novartis Investigator Site
City
Waterloo
Country
Canada
Facility Name
Novartis Investigator Site
City
Windsor
Country
Canada
Facility Name
Novartis Investigator Site
City
Winnipeg
Country
Canada
Facility Name
Novartis Investigator Site
City
Augsburg
Country
Germany
Facility Name
Novartis Investigator Site
City
Bad Segeberg
Country
Germany
Facility Name
Novartis Investigator Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigator Site
City
Bielefeld
Country
Germany
Facility Name
Novartis Investigator Site
City
Bonn
Country
Germany
Facility Name
Novartis Investigator Site
City
Bruhl
Country
Germany
Facility Name
Novartis Investigator Site
City
Dachau
Country
Germany
Facility Name
Novartis
City
Fuerth
Country
Germany
Facility Name
Novartis Investigator Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigator Site
City
Hoyerswerda
Country
Germany
Facility Name
Novartis Investigator Site
City
Kaufbeuren
Country
Germany
Facility Name
Novartis Investigator 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
Muenchen
Country
Germany
Facility Name
Novartis Investigator Site
City
Oranienburg
Country
Germany
Facility Name
Novartis Investigator Site
City
Oschersleben
Country
Germany
Facility Name
Novartis Investigator Site
City
Potsdam
Country
Germany
Facility Name
Novartis Investigator Site
City
Ratingen
Country
Germany
Facility Name
Novartis Investigator Site
City
Steinfurt
Country
Germany
Facility Name
Novartis Investigator Site
City
Wuppertal
Country
Germany
Facility Name
Novartis Investigator Site
City
Bangalore
Country
India
Facility Name
Novartis Investigator Site
City
Banglore
Country
India
Facility Name
Novartis Investigator Site
City
Caranazalem
Country
India
Facility Name
Novartis Investigator Site
City
Chennai
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
Kolkatta
Country
India
Facility Name
Novartis Investigator Site
City
Ludhiana
Country
India
Facility Name
Novartis Investigator Site
City
Mumbai
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
Chioggia
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
Genova
Country
Italy
Facility Name
Novartis Investigator Site
City
Messina
Country
Italy
Facility Name
Novartis Investigator Site
City
Milano
Country
Italy
Facility Name
Novartis
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
Bucheon
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Busan
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Chuncheon
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Daegu
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Kwangju
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Suwon
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Wonju
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Ponce
ZIP/Postal Code
716
Country
Puerto Rico
Facility Name
Novartis Investigator Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigator Site
City
Barcelona
Country
Spain
Facility Name
Novartis
City
Barcelona
Country
Spain
Facility Name
Novartis Investigator Site
City
Burgos
Country
Spain
Facility Name
Novartis Investigator Site
City
Cadiz
Country
Spain
Facility Name
Novartis Investigator Site
City
Calde Lugo
Country
Spain
Facility Name
Novartis Investigator Site
City
Galdakano
Country
Spain
Facility Name
Novartis Investigator Site
City
Gerona
Country
Spain
Facility Name
Novartis Investigator Site
City
Gran Canaria
Country
Spain
Facility Name
Novartis Investigator Site
City
La Coruna
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 Investigator Site
City
Pontevedra
Country
Spain
Facility Name
Novartis Investigator Site
City
Puerto de Sagunto
Country
Spain
Facility Name
Novartis Investigator 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 Investigator Site
City
Zaragoza
Country
Spain
Facility Name
Novartis
City
Goteborg
Country
Sweden
Facility Name
Novartis Investigator Site
City
Jonkoping
Country
Sweden
Facility Name
Novartis Investigator Site
City
Lidingo
Country
Sweden
Facility Name
Novartis Investigator Site
City
Lulea
Country
Sweden
Facility Name
Novartis Investigator Site
City
Lund
Country
Sweden
Facility Name
Novartis Investigator Site
City
Chiayi
Country
Taiwan
Facility Name
Novartis Investigator Site
City
LinKou
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Taichung
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Taipei
Country
Taiwan
Facility Name
Novartis
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Anakara
Country
Turkey
Facility Name
Novartis
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigator Site
City
Konya
Country
Turkey
Facility Name
Novartis Investigator Site
City
Manisa
Country
Turkey
Facility Name
Novartis Investigator Site
City
Mersin
Country
Turkey
Facility Name
Novartis Investigator Site
City
Yenisehir
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22206353
Citation
Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.
Results Reference
derived
PubMed Identifier
22158330
Citation
Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.
Results Reference
derived
PubMed Identifier
21397482
Citation
Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.
Results Reference
derived
PubMed Identifier
21227674
Citation
Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.
Results Reference
derived
PubMed Identifier
20463178
Citation
Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, Iqbal A, Swales J, Owen R, Higgins M, Kramer B; INHANCE Study Investigators. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010 Jul 15;182(2):155-62. doi: 10.1164/rccm.200910-1500OC. Epub 2010 May 12.
Results Reference
derived

Learn more about this trial

26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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