Study B2C111045, A Dose-Finding Study of GW642444 versus Placebo in Patients with COPD
- Conditions
- -J449 Chronic obstructive pulmonary disease, unspecifiedChronic obstructive pulmonary disease, unspecifiedJ449
- Registration Number
- PER-005-08
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Informed Consent: The subjects that sign the written informed consent to participate.
• Sex: Male or Female Subjects between the ages of 40 and 80 at Visit 1. A woman is eligible to enter and participate in the study if: She has no reproductive potential (ie, she is physiologically unable to get pregnant, including postmenopausal women); o Has reproductive potential; a pregnancy test has been performed on the screening with a negative result, and accepts one of the acceptable contraceptive methods used in a consistent and correct manner (ie according to the approved product leaflet and the doctor´s instructions for the duration of the study; from the selection to the follow-up contact)
• COPD diagnosis: Subjects with established clinical history of COPD according to the following definition of the American Thoracic Society / European Respiratory Society [Celli, 2004]; COPD is a preventable and treatable disease characterized by limited airflow that is not fully reversible. The limitation to air flow is usually progressive and is associated with an abnormal inflammatory response of the lungs to harmful particles or gases, mainly due to smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
• Tobacco use: Must have current or past history as a cigarette smoker of at least 10 packages a year. [number of packages per year = (number of cigarettes per day / 20) x number of years of smoker (for example, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years.) Ex-smokers are defined as Subjects who have quit smoking for at least 6 months before Visit 1.
• Severity of the disease: Subjects with an FEVi / FVC ratio measured post-salbutamol <0.70 in Visit 1 (Selection). Subjects with FEVi measured post-salbutamol ^ 5 and <70% of predicted normal values calculated using the reference equations of NHANES III in Visit 1 (Selection).
• Pregnancy: Pregnant or breastfeeding women.
• Asthma: Subjects with a primary diagnosis of asthma. (Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis)
• Ai-antitrypsin deficiency: Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD.
• Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung disease or other active pidmonar disease.
• Lung resection: Subjects with lung volume reduction surgery within the previous 12 months.
• Chest x-ray: Chest x-ray (or chest CT) that reveals evidence of clinically significant abnormalities that are not considered to be due to the presence of COPD. A chest x-ray should be taken if there is no chest x-ray or chest CT available for the 6 months prior to the Screening Visit. For centers in Germany, if there is no chest X-ray (or CT) available for the 6 months prior to the Selection (Visit 1), the subject will not be eligible to participate in the study.
• Hospitalization: Subjects hospitalized due to poorly controlled COPD within 12 weeks of the screening visit.
• Poorly controlled COPD: Subjects with poorly controlled COPD, which is defined as the manifestation of any of the following events in the 6 weeks prior to Visit 1: acute exacerbation of COPD that is treated by the subject with corticosteroids or antibiotics, or acute exacerbation of COPD requiring treatment prescribed by the physician
• Other diseases / abnormalities: Subjects with cardiovascular, neurological, psychiatric, renal, immunological, endocrine abnormalities (including uncontrolled diabetes or thyroid disease) clinically significant, or uncontrolled hematologic abnormalities.
• Infection of the lower respiratory tract: Subjects with lower respiratory tract infections that require the use of antibiotics within 6 weeks prior to the visit 1.
• 12-lead ECG: An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in an active medical problem.
• Hypertension: Subjects with clinically significant hypertension that is not controlled.
• Hepatitis: Subjects with positive Hepatitis B surface antigen or positive hepatitis C antibody before the study or in the Selection.
• Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. In situ carcinoma of the cervix, squamous cell carcinoma, and basal cell carcinoma would not be excluded if the subject was considered cured less than 5 years after diagnosis.
• Allergy to any drug: Subjects with a history of hypersensitivity to a beta agonist or to a component of the MDI and / or nebula, or sensitivity to any of the components of the dry powder product (magnesium stearate or lactose). Likewise, patients with a history of severe allergy to milk protein would be excluded.
• Drug abuse: Subjects with a known or suspected history of alcohol or drug abuse in the past 2 years.
• Medication prior to spirometry: Subjects who, for medical reasons, can not interrupt the use of salbutamol during the 6-hour period required before the spirometry test at each study visit would not be eligible for the study.
• Additional medications: Certain medications are not allowed during the study, and they must not have been taken for the periods indicated prior to Visit 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:It will be analyzed using a linear model with FEVi covariates basal valley, reversibility stratum, sex, age, smoking status and dose of GW642444.<br>Measure:Change from the basal value in FEV1 valley<br>Timepoints:Day 29<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:It will use the specified methodology for the primary analysis of the primary evaluation parameter.<br>Measure:Weighted average FEV1 of 24h<br>Timepoints:Days 1 and 28<br>;<br>Outcome name:(increase of> 12% above the baseline value in FEV1) will be analyzed using appropriate survival methods depending on the distribution of the data.<br>Measure:Time at the beginning<br>Timepoints:Days 1 and 28<br>;<br>Outcome name:The methodology specified for the primary analysis of the primary evaluation parameter will be used.<br>Measure:FEV1 weighted average of 4h<br>Timepoints:Days 1, 14 and 28<br>