Resumen

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

Descripción detallada

A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS),
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be \<0.70 and FEV1 must be \<65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
Subjects with history of exacerbations.

Criterios de exclusión

Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening)
Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening)
Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.

Ubicaciones

Research Site

Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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CABA, Argentina

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Capital Federal, Argentina

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Ciudad Autonoma de Buenos Aire, Argentina

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Ciudad Autonoma de Buenos Aire, Argentina

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Ciudad Autonomade Buenos Aires, Argentina

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Ciudad Autónoma de Bs. As., Argentina

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Ciudad Capital, Argentina

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Ciudad de Buenos Aire, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Florida, Argentina

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La Plata, Argentina

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Lanús, Argentina

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Mar del Plata, Argentina

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Mar del Plata, Argentina

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Mendoza, Argentina

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Mendoza, Argentina

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Mendoza, Argentina

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Monte Grande, Argentina

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Paraná, Argentina

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Quilmes, Argentina

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Rosario, Argentina

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Rosario, Argentina

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Rosario, Argentina

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San Fernando, Argentina

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San Juan Bautista, Argentina

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San Miguel de Tucumán, Argentina

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San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Santa Fe, Argentina

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Santa Rosa, Argentina

A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

BGF MDI 320/14.4/9.6 μg

GFF MDI 14.4/9.6 μg

BGF MDI 160/14.4/9.6 μg

BFF MDI 320/9.6 μg

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