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

NCT ID: NCT00677807

Last Updated: 2011-08-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Indacaterol 150 µg

Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Indacaterol 300 µg

Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Placebo

Placebo once-daily (o.d.) via SDDPI.

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Interventions

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Indacaterol

Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Intervention Type DRUG

Placebo

Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

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


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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Homewood, Alabama, United States

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Jasper, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Pine Bluff, Arkansas, United States

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Encinitas, California, United States

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Fullerton, California, United States

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Orange, California, United States

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Riverside, California, United States

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Spring Valley, California, United States

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Fort Collins, Colorado, United States

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Golden, Colorado, United States

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Wheat Ridge, Colorado, United States

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Clearwater, Florida, United States

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Largo, Florida, United States

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Pensacola, Florida, United States

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Rockledge, 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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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Normal, Illinois, United States

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O'Fallon, Illinois, United States

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River Forest, Illinois, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Iowa City, Iowa, United States

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Topeka, Kansas, United States

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Crescent Springs, Kentucky, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Lafayette, Louisiana, United States

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Metaire, Louisiana, United States

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Biddeford, Maine, United States

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Flint, Michigan, United States

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Livonia, Michigan, United States

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Troy, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Chesterfield, Missouri, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Rosario, , Argentina

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Kaufbeuren, , Germany

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Landsberg, , Germany

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Ratingen, , Germany

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Steinfurt-Borghorst, , Germany

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Bangalore, , India

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Chennai, , India

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Coimbatore, , India

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Coimbatore, , India

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Indore, , India

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Kolkata, , India

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Ludhiana, , India

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Panjim, , India

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Trivandrum, , India

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Bologna, , Italy

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Busto Arsizio, , Italy

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Catania, , Italy

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Catanzaro, , Italy

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Crema, , Italy

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Sottomarina, , Italy

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Alicante, , Spain

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Alzira, , Spain

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Barcelona, , Spain

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Burgos, , Spain

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Córdoba, , Spain

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Girona, , Spain

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Gladakano, , Spain

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Jerez de Frontera, , Spain

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Las Palmas de Gran Canaria, , Spain

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Las Palmas de Gran Canarias, , Spain

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Lugo, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Ourense, , Spain

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Oviedo, , Spain

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Palma de Mallorca, , Spain

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Ponferrada, , Spain

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Pontevedra, , Spain

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Port de Sagunt, , Spain

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Seville, , Spain

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Valencia, , Spain

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Vic, , Spain

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Vila-real, , Spain

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Zaragoza, , Spain

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Gothenburg, , Sweden

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Jönköping, , Sweden

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Lidingö, , Sweden

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Luleå, , Sweden

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Luleå, , Sweden

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Lund, , Sweden

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Kartal/Istanbul, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Yenisehir/Izmir, , Turkey (Türkiye)

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Countries

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United States Argentina Canada Germany India Italy Spain Sweden Turkey (Türkiye)

References

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

Reference Type DERIVED
PMID: 21349928 (View on PubMed)

Other Identifiers

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2008-000663-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAB149B2335SE

Identifier Type: -

Identifier Source: org_study_id

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