COPD Subjects with an Asthmatic Component MedDRA version: 17.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 MedDRA version: 17.1 Level: LLT Classification code 10009028 Term: Chronic obstructive asthma (with obstructive pulmonary disease) System Organ Class: 100000004855
Conditions
Interventions
Product Name: Fluticasone Furoate / umeclidinium
Product Code: Fluticasone Furoate / umeclidinium
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: FLUTICASONE FUROATE
CAS N
Sponsors
GlaxoSmithKline Research & Devlopment Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18 years of age or older at Visit 0 2. Diagnosis: At the point of screening subjects, have sufficient medical history (e.g., signs and symptoms) to diagnose the subject as having COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society (Celli, 2004), AND evidence of an asthmatic component as demonstrated by spirometry, reversibility and current therapy at Visit 1 as follows: A. Spirometry: 1. A best post-bronchodilator morning (AM) FEV1 =50% and =80% of the predicted normal value at Visit 1 will be based upon the ERS Global Lung Function Initiative. AND 2. Pre- and post-bronchodilator FEV1/FVC ratio 45 years, in the absence of hormone replacement therapy). OR Child bearing potential: Has a negative pregnancy test at screening and agrees to use an acceptable contraceptive method consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow-up contact). The following is the GSK list of acceptable, highly effective methods for avoiding pregnancy wit
Exclusion criteria
Exclusion criteria: 1. History of Life-threatening Respiratory Event: Defined for this protocol as an episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years. 2. Respiratory Infection: Any infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in COPD/asthma management or, in the opinion of the investigator, is expected to affect the subject’s COPD/asthma status or the subject’s ability to participate in the study. 3. Severe Exacerbation: A subject must not have had an exacerbation prior to Visit 1 meeting either of the following criteria: - Deterioration of COPD or asthma requiring either the use of oral corticosteroids for at least 3 days or parenteral corticosteroids in the previous 3 months. - An in-patient hospitalization or emergency department visit due to COPD or asthma that required any oral or parenteral corticosteroids in the previous 6 months For consistency, courses of corticosteroids separated by 1 week or more should be treated as separate exacerbations.4. Risk Factors for Pneumonia: Immune suppression (e.g., Human Immunodeficiency Virus [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). Please view protocol for further information. 5. Pneumonia: Hospitalization for pneumonia within 3 months prior to Visit 1. 6. Concurrent Respiratory Disease: A subject must not have current evidence of the following: pneumonia, pneumothorax, atelectasis (segmental or larger), pulmonary fibrotic disease, bronchopulmonary dysplasia, or other respiratory abnormalities other than chronic obstructive pulmonary disease (including chronic bronchitis and emphysema) or asthma. Please view protocol for further information. 7. Other Concurrent Diseases/Abnormalities: A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation. Please view protocol for further information. 8. Viral Hepatitis and HIV: A positive Hepatitis B surface antigen or positive Hepatitis C antibody pre-study or at Visit 1. Subjects with HIV-positive history are not eligible. 9. Hepatic Impairment: Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). 10. Allergies: - Drug Allergy: Any immediate or delayed hypersensitivity reaction to a ß2 agonist, sympathomimetic drug, corticosteroid please view protocol for further information. 11. Concomitant Medication: Administration of prescription or over-the-counter medication that would significantly affect the course of COPD or asthma, or interact with study drug, please view protocol for further information. 12. Lung Resection: Subjects with lung volume reduction surgery within 12 months prior to Visit 1. 13. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., =12 hours per day) is not exclusionary. 14. Nebulized Therapy: Regular use (prescribed for use every day) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy. As-needed nebulized albuterol/salbutamol use is not exclusionary. 15. Pulmonary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the dose-response of once-daily UMEC in combination with FF (100/15.6, 100/62.5, 100/125, and 100/250 mcg) compared to FF 100 mcg monotherapy over a 4-week treatment period in COPD subjects with an asthmatic component.;Secondary Objective: To evaluate the treatment effect of FF/UMEC compared to the combination of FF and VI over a 4-week treatment period in COPD subjects with an asthmatic component. Exploratory Objective(s) - To evaluate the treatment effect of VI in COPD subjects with an asthmatic component treated with FF/UMEC - To evaluate the effect on lung function of discontinuing UMEC in COPD subjects with an asthmatic component - To explore the relationship of patient reported outcomes (PROs) with patient characteristics such as level of reversibility and obstruction, diagnosis and other measures of disease severity - To explore the responsiveness of PRO measures to response on other outcomes and determine potential responder definitions - To determine differential responses and their phenotypic characteristics by exploratory and subgroup analyses Other Objective(s) - To evaluate the safety of FF/UMEC therapy;Primary end point(s): Change from baseline in clinic trough (pre-dose) FEV1 at the end of Treatment Phase A;Timepoint(s) of evaluation of this end point: Visit 3 (baseline) and Visit 6 (Week 4, Day 29) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 28 and Day 29;Secondary end point(s): Mean change from baseline in rescue medication use at the end of Treatment Phase A Mean change from baseline in EXACT-RS score at the end of Treatment Phase A Change from baseline in daily morning (AM) PEF (pre-dose and pre-rescue bronchodilator) measured at home and averaged over the last 21 days of Treatment Phase A Change from trough in FEV1 at 3 hours post-study treatment at Visit 5 Change in clinic FEV1 following 2 puffs of albuterol/salbutamol given 3 hours post-study treatment dose at Visit 5 | — |
Countries
Argentina, Germany, Poland, Romania, Russian Federation, Ukraine, United States
Contacts
Public ContactClinical Trials HelpDesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed