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

NCT ID: NCT00877383

Last Updated: 2011-08-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-02-28

Brief Summary

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

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A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indacaterol 150 μg and tiotropium 18 μg

Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol 150 μg

Intervention Type DRUG

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Tiotropium 18 μg

Intervention Type DRUG

Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®).

Tiotropium 18 μg

Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type ACTIVE_COMPARATOR

Tiotropium 18 μg

Intervention Type DRUG

Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®).

Placebo to indacaterol

Intervention Type DRUG

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Interventions

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Indacaterol 150 μg

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Intervention Type DRUG

Tiotropium 18 μg

Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®).

Intervention Type DRUG

Placebo to indacaterol

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Exclusion Criteria

* Patients who have received systemic corticosteroids and/or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Jasper, Alabama, United States

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Mobile, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Buena Park, California, United States

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Fullerton, California, United States

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Mission Viejo, California, United States

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San Ramon, California, United States

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Santa Barbara, California, United States

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Sepulveda, California, United States

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Spring Valley, California, United States

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Torrance, California, United States

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Torrance, California, United States

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Vista, California, United States

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Boulder, Colorado, United States

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Centennial, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Glastonbury, Connecticut, United States

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Waterbury, Connecticut, United States

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Clearwater, Florida, United States

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Destin, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Ocala, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Port Orange, Florida, United States

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South Miami, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Couer D'Alene, Idaho, United States

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Downers Grove, Illinois, United States

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Elk Grove Village, Illinois, United States

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River Forest, Illinois, United States

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Springfield, Illinois, United States

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Shawnee, Kansas, United States

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Crescent Springs, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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Waldorf, Maryland, United States

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Burlington, Massachusetts, United States

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Troy, Michigan, United States

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Chaska, Minnesota, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Saint Paul, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Ozark, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Kalispell, Montana, United States

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Bellevue, Nebraska, United States

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Lincoln, Nebraska, United States

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Papillion, Nebraska, United States

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Henderson, Nevada, United States

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Brick, New Jersey, United States

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New Brunswick, New Jersey, United States

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Ocean City, New Jersey, United States

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Bayside, New York, United States

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Great Neck, New York, United States

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Larchmont, New York, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Shelby, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Grand Forks, North Dakota, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Allentown, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Phoenixville, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Easley, South Carolina, United States

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Greenville, South Carolina, United States

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North Charleston, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Abingdon, Virginia, United States

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Fredericks, Virginia, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Gatineau, , Canada

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Joliette, , Canada

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Mirabel, , Canada

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Mississauga, , Canada

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Montreal, , Canada

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Québec, , Canada

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Saint-Jérôme, , Canada

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Sainte-Foy, , Canada

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Sherbrooke, , Canada

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Toronto, , Canada

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Trois-Rivières, , Canada

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Windsor, , Canada

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Armenia, , Colombia

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Cali, , Colombia

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Karlovy Vary, , Czechia

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Kladno, , Czechia

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Kroměříž, , Czechia

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Liberec, , Czechia

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Rokycany, , Czechia

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Strakonice, , Czechia

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Třebíč, , Czechia

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Érd, , Hungary

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Füzesabony, , Hungary

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Győr, , Hungary

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Százhalombatta, , Hungary

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Ahmedabad, , India

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Bangalore, , India

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Coimbatore, , India

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Hyderabad, , India

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Indore, , India

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Jaipur, , India

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Ludhiana, , India

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Panjim, , India

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Trivandrum, , India

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Almelo, , Netherlands

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Breda, , Netherlands

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Heerlen, , Netherlands

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Helmond, , Netherlands

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Veldhoven, , Netherlands

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Zutphen, , Netherlands

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Banská Bystrica, , Slovakia

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Bardejov, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Martin, , Slovakia

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Poprad, , Slovakia

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Považská Bystrica, , Slovakia

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Štúrovo, , Slovakia

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Alicante, , Spain

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Almería, , Spain

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Barakaldo, , Spain

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Madrid, , Spain

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Palma de Mallorca, , Spain

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Pozuelo de Alarcón, , Spain

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Riudecols, , Spain

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San Boi de Llobregat, , Spain

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Seville, , Spain

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Vilassar de Mar, , Spain

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Countries

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United States Canada Colombia Czechia Hungary India Netherlands Slovakia Spain

References

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

Reference Type DERIVED
PMID: 22544891 (View on PubMed)

Other Identifiers

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CQAB149B2351

Identifier Type: -

Identifier Source: org_study_id

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