In This SectionTexas Health Research & Education Institute
Disease or Condition
Pulmonary - COPD
A 52-week efficacy and safety study to compare the effect of three dosage strengths of fluticasone furoate/GW642444 combination with GW642444 on the Annual Rate of Exacerbations in Subjects with chronic Obstructive Pulmonary Disease (COPD).
This is a randomized, double-blind, parallel group, multi-center, study that looks at the effect of a combination of two experimental medicines, fluticasone furoate (FF), (an inhaled steroid) and GW642444 (a bronchodilator) in people with Chronic Obstructive Pulmonary Disease (COPD). The combination of these two drugs is called FF/GW642444, which is an investigational drug being studied for use in people with COPD and has not yet been approved by the U.S. Food and Drug Administration (FDA). This study is designed to evaluate the effectiveness and safety of three dosage strengths of this compound, taken once daily in the morning. Fluticasone furoate (FF), an inhaled corticosteroid is FDA approved. GW642444,a bronchodilator, is not yet FDA approved.
Must be outpatient.
Subjects must give their signed written informed consent to participate.
Gender: Male or female subjects.
A female is eligible to participate in the study if she is non-child bearing potential, or surgically sterile, or has child bearing potential, with a negative pregnancy test at screening, and agrees to an acceptable contraceptive, or male partner is sterile.
Age: =40 years of age at screening visit.
COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
Tobacco use: Subjects with a current or prior history of =10 pack-years of cigarette smoking at screening.
Severity of Disease: Subjects with a measured post-albuterol/salbutamol FEV1/FVC ratio of =0.70 at screening (Visit 1). Subjects with a measured post-albuterol/salbutamol FEV1 =70% of predicted normal values at screening.
History of Exacerbations: A documented history of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization.
Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
a1-antitrypsin deficiency: Subjects with a-1 antitrypsin deficiency as the underlying cause of COPD.
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to screening.
Chest X-ray: Reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD.
Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway).
A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids.
Pneumonia and/or moderate and severe COPD exacerbation at Visit 1.
Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine or hematological abnormalities that are uncontrolled.
Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications or components of the inhalation powder . In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates
the subject’s participation will also be excluded.
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy or nocturnal oxygen therapy required for greater than 12 hours a day.
Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
Prior use of study medication/other investigational drugs.