A PHASE III, 52 WEEK, RANDOMIZED, DOUBLE-BLIND, 3-ARM PARALLEL GROUP STUDY, COMPARING THE EFFICACY, SAFETY AND TOLERABILITY OF THE FIXED DOSE TRIPLE COMBINATION FF/UMEC/VI WITH THE FIXED DOSE DUAL COMBINATIONS OF FF/VI AND UMEC/VI, ALL ADMINISTERED ONCE-DAILY IN THE MORNING VIA A DRY POWDER INHALER IN SUBJECTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

GlaxoSmithKline,0 sites189 target enrollmentStarted: October 24, 2014Last updated: September 4, 2023

Conditions

Trial Snapshot

No summary available.

•Subjects eligible for enrolment in the study must meet all of the following criteria:
•1. Informed Consent: A signed and dated written informed consent prior to study participation.
•2. Type of subject: Outpatient.
•3. Age: Subjects 40 years of age or older at Visit 1.
•4. Gender: Male or female subjects.
•5. COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
•6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening (visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history
•7. Severity of COPD symptoms: A score of ≥10 on the COPD Assessment Test (CAT) at screening.
•8. Severity of COPD Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 at Screening.

•Subjects meeting any of the following criteria must not be enrolled in the study:
•1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
•2. 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).
•3. α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD.
•4. Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
•5. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening.
•6. Risk Factors for Pneumonia: immune suppression (e.g. HIV, Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson’s Disease, Myasthenia Gravis)
•Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.

Sponsor

GlaxoSmithKline,