Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)
NCT ID: NCT01555138
Last Updated: 2015-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
581 participants
INTERVENTIONAL
2012-02-29
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Indacaterol
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Indacaterol
Indacaterol is delivered via a SDDPI.
Salmeterol/fluticasone propionate
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
Salmeterol
Salmeterol/fluticasone is delivered via a MDDPI
Interventions
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Indacaterol
Indacaterol is delivered via a SDDPI.
Salmeterol
Salmeterol/fluticasone is delivered via a MDDPI
Eligibility Criteria
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Inclusion Criteria
* Able to perform spirometry assessments
* Current or ex-smokers
* On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1.
Exclusion Criteria
* Having a history of, or current ECG abnormality
* Asthma
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Caba, Argentina, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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C A B A, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Villa María, Córdoba Province, Argentina
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Concepción del Uruguay, Entre Ríos Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Santa Fe, Rosario, Argentina
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Salta, Salta Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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Bogota, Cundinamarca, Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Acquaviva delle Fonti, BA, Italy
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Cassano delle Murge, BA, Italy
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Treviglio, BG, Italy
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Bologna, BO, Italy
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Caserta, CE, Italy
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Forlì, FC, Italy
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Cona, FE, Italy
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Foggia, FG, Italy
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Cassino, FR, Italy
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Genova, GE, Italy
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Messina, ME, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Sesto San Giovanni, Mi, Italy
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Cittadella, PD, Italy
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Pisa, PI, Italy
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Pordenone, PN, Italy
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Parma, PR, Italy
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Pavia, PV, Italy
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Salerno, SA, Italy
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Cuasso al Monte, VA, Italy
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Tradate, VA, Italy
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Negrar, VR, Italy
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Verona, VR, Italy
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Wilayah Persekutuan, Kuala Lumpur, Malaysia
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Kuching, Sarawak, Malaysia
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Pulau Pinang, , Malaysia
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Querétaro City, Querétaro, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Breda, Netherlands, Netherlands
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Helmond, Netherlands, Netherlands
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Rotterdam, , Netherlands
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Loja, Andalusia, Spain
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Sanlúcar de Barrameda, Andalusia, Spain
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Valladolid, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Canet de Mar, Catalonia, Spain
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Corbera de Llobregat, Catalonia, Spain
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Lleida, Catalonia, Spain
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Madrid, Madrid, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Muenchenstein, Switzerland, Switzerland
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Basel, , Switzerland
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Biel, , Switzerland
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Gossau, , Switzerland
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Newcastle upon Tyne, Newcastle-upon-Tyne, United Kingdom
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Dundee, Perthshire, United Kingdom
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Hants, Southampton, United Kingdom
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Bradford, , United Kingdom
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Chester, , United Kingdom
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East Yorkshire, , United Kingdom
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Kettering, , United Kingdom
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Lancaster, , United Kingdom
Novartis Investigative Site
Surrey, , United Kingdom
Countries
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Other Identifiers
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2011-003732-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQAB149B2401
Identifier Type: -
Identifier Source: org_study_id
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