None listed
Conditions
Interventions
Group 1 Type of group
FF / GW642444 50 mcg / 25 mcg once a day AM, for 52 weeks
Group name:Group 4 Type of group
GW642444 25 mcg once a day AM, for 52 weeks
Sponsors
GlaxoSmithKline,
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Type of subject: Outpatient. • Informed consent: The subjects must give their written, signed and dated informed consent to participate. • Gender: Male or female subjects. A female subject is eligible to enter and participate in this study if: It has no reproductive potential (that is, it is physiologically incapable of becoming pregnant, including any postmenopausal or surgical sterilization participant). Women with surgical sterilization are defined as those who underwent a documented hysterectomy and / or bilateral oophorectomy or tubal ligation. Postmenopausal women are defined as those with amenorrhea for more than 1 year with an adequate clinical profile, for example, adequate age,> 45 years, in the absence of hormone replacement therapy. However, in questionable cases, a blood sample with FSH> 40MIU / ml and estradiol 40 years in the National Team (Visit 1) • Diagnosis of COPD: Subjects with a clinical history of COPD, as defined by the US Thoracic Society. of NA./the European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease, characterized by the limitation of air flow that is not fully reversible. The limitation of air flow is usually progressive and is associated with the abnormal inflammatory response of the lungs to harmful particles or gases, mainly caused by cigarette smoke. Although it affects the lungs, COPD also produces significant systemic consequences. • Tobacco use: Subjects with current or previous history of> 10 packs / year of smoking cigarettes at the time of selection (Visit 1). Ex-smokers are defined as those who stopped filming for at least 6 months before Visit 1. • Disease severity: Subject to a FEV1 / FVC ratio calculated after administration of albuterol / salbutamol of <0.70 in the Selection (Visit 1). Subjects with a FEV1 <70% measured after administration of albuterol / salbutamol of the expected normal values ​​calculated, using the reference equations of NHANES III [Hankinson, 1999] in the Selection (Visit 1). • History of exacerbations: Documented history (for example, verification of medical records) of at least one exacerbation of COPD in the 12 months prior to Visit 1, which required either oral corticosteroids, antibiotics and / or hospitalization. Previous use of antibiotics alone will not be considered a history of exacerbation, unless the use was associated with the treatment of aggravated COPD symptoms, such as increased dyspnea, sputum volume or purulence (color) of sputum. Subject verbal reports will not be acceptable.
Exclusion criteria
Exclusion criteria: • Pregnancy: Women who are pregnant or breastfeeding or who are planning to become pregnant during the study. • Asthma: Subjects with a current diagnosis of asthma. (Subjects with a previous history of asthma are eligible if they have a current diagnosis of COPD.) • Al-antipypsin deficiency: Subjects with a deficiency of a-1 antitrypsin as the underlying cause of COPD. • Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension and interstitial lung diseases or other active lung diseases. • Pulmonary resection: Subjects with lung volume reduction surgery within 12 months before Selection. • Chest x-ray: Chest x-ray (posteroanterior with lateral) reveals evidence of pneumonia or a clinically significant abnormality that is not considered to be caused by the presence of COPD or another condition that would hamper the ability to detect a CXR infiltrate (for example , cardiomegaly, effusion or pleural scar etc.). All subjects will undergo a chest x-ray on Selection Visit 1 (or a historical x-ray obtained within 2 weeks before the Selection) that will be reevaluated by a central provider. • Risk factors for pneumonia: Immunosuppression (HIV, Lupus, etc.) or other risk of pneumonia (for example, neurological disorders that affect the control of the upper airway, such as Parkinson´s disease, Myasthenia Gravis, etc.). • Exacerbation of moderate and severe COPD that is not resolved, at least, up to 14 days before Visit 1 and at least 30 days after the last dose of oral corticosteroids (if applicable). • Pneumonia and / or exacerbation of moderate and severe COPD at Visit 1 Note: Subjects experiencing pneumonia and / or exacerbation at Selection (Visit 1) should not continue in the study, but may be re-selected later, provided pneumonia and / or exacerbation of COPD has been resolved before the reselection visit. At the reselection visit, the chest radiograph should confirm the resolution of the pneumonia. The reselection visit should be carried out at least> 14 days after the resolution date of the exacerbation and / or pneumonia and at least 30 days after the last dose of oral corticosteroids (if applicable). • Other diseases / anomalies: Subjects with historical or current evidence of clinically significant cardiovascular (ie, pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or uncontrolled hematologic abnormalities. Significant is defined as any disease that, in the opinion of the researcher, would jeopardize the safety of the subject through their participation or that would influence the analysis of efficacy or safety if the disease / condition was exacerbated during the study. • Peptic ulcer disease: Subjects with clinically significant, uncontrolled peptic ulcer disease. • Hypertension: Subjects with clinically significant, uncontrolled hypertension. • Cancer: Subjects with carcinoma without complete remission for at least 5 years. In situ cervical carcinoma, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject were considered cured within 5 years of diagnosis. • Food / drug allergy: Subjects with a history of hypersensitivity to any of the study medications (for example, beta-agonists, corticosteroids) or components of the inhalation powder (for example, lactose, ma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization. Measure:Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean Timepoints:From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented. Measure:Time to First Occurrence of Moderate or Severe COPD Exacerbation Timepoints:From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal ; Outcome name:The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that r | — |
Countries
Argentina, Australia, Canada, Chile, Estonia, Germany, Italy, Mexico, Netherlands, Philippines, South Africa, Sweden, United Kindgdom, United States
Contacts
Public ContactSarita Mattos
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed