A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma

GlaxoSmithKline Research & Development Ltd0 sites2,250 target enrollmentJuly 22, 2016

Overview

No summary available.

Registry

who.int

Start Date

July 22, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. 18 years of age or older at the time of signing the informed consent.
•TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
•2\. Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health at least one year prior to Visit 0\.
•3\. Symptomatic: Subjects with inadequately controlled asthma despite ICS/LABA maintenance therapy at Visit 1\.
•4\. Asthma Control: A documented non\-routine healthcare visit due to acute asthma symptoms in the 1 year prior to Visit 1\.
•5\. Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of \>250 mcg/day fluticasone proprionate
•Examples of acceptable doses of commonly prescribed ICS and LABA or ICS/LABA combination medication is provided in the Study Reference Manual (SRM). Dosing regimen should be restricted to the current local product labels.
•6\. Spirometry:
•A best pre\-bronchodilator morning FEV1 \=30% and \<85% of the predicted normal value at Visit 1\. Predicted values will be based upon the European Respiratory Society Global Lung Function Initiative
•7\. Reversibility of Disease: airway reversibility defined as \=12% and \=200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1\.

•CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER
•FUNCTION AND QTc INTERVAL)
•1\. Pneumonia: Chest X\-ray documented pneumonia in the 6 weeks prior to Visit 1\.
•2\. Asthma Exacerbation: Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1\.
•Note: Subjects who experience an asthma exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator’s discretion, the subject’s condition is stable and they are considered appropriate for enrolment into this study of up to 12 months’ duration.
•3\. Chronic Obstructive Pulmonary Disease: Subjects with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease guidelines, including all of the following:
•\-History of exposure to risk factors;
•\-A post\-albuterol/salbutamol FEV1/Forced Vital Capacity ratio of \<0\.70 and a post\-albuterol/salbutamol FEV1 of \=70% of predicted normal values;
•\-Onset of disease \=40 years of age
•4\. Concurrent respiratory disorders: Subjects with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.