Resumen

The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

years of age or older
COPD with evidence of an asthmatic component as demonstrated by spirometry, reversibility and current therapy at screening as follows:
Post-bronchodilator morning (AM) FEV1 \>=50% and \<=80% of the predicted normal value at Visit 1
Pre- and post-bronchodilator FEV1/FVC ratio \<0.7.
Demonstrated reversibility by \>=12% and \>=200 mL increase in FEV1 following albuterol at Visit 1.
A need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long-acting beta-agonist or leukotriene modifier, etc.) for a minimum of 12 weeks prior to Visit 1.
Outpatient subjects who are smokers or non-smokers.

Criterios de exclusión

Requirement for nebulized therapy
History of life-threatening respiratory event within the last 5 years.
Unresolved respiratory infection
Recent Severe COPD or Asthma Exacerbation
Risk factors for pneumonia
Hospitalization for pneumonia within 3 months
Concurrent respiratory disease other than chronic obstructive pulmonary disease or asthma.
Other uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
Viral hepatitis or HIV
Current or chronic history of liver disease, known hepatic or biliary abnormalities
Drug or milk protein allergy
Administration of prescription or over-the-counter medication that would significantly affect the course of COPD or asthma, or interact with study drug
Subjects with lung volume reduction surgery within 12 months prior to screening.
Use of long-term oxygen therapy (LTOT)
Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks
Unstable or life-threatening cardiac disease
Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding
Diseases preventing the use of anticholinergics

Intervenciones

drug

FF

Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister), combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

drug

UMEC

Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister)

drug

VI

Vilanterol is available as vilanterol inhalation powder (25 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

Ubicaciones

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

San Rafael, Mendoza Province, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

200699: A Clinical Study to Evaluate Four Doses of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

FF

UMEC

VI

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores