Chronic obstructive pulmonary disease (COPD) MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Product Code: GSK2834425
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed IN
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: capable of giving signed informed consent prior to study start which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Type of participant: Outpatient. 3. Age: Participants 40 years of age or older at Screening (Visit 1). 4. Gender: Male or female participants. Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 of the protocol during the treatment period and until the safety follow-up contact after the last dose of study treatment. 5. COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]. 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 (Visit 1). 8. Severity of Disease: Participants must demonstrate at Screening: a post-bronchodilator FEV1=65 years) yes F.1.3.1 Number of subjects for this age range 366
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. 2. Asthma: Participants with a current diagnosis of asthma. (Participants with a prior history of asthma are eligible if they have a current diagnosis of COPD). 3. a1-antitrypsin deficiency: Participants with a1-antitrypsin deficiency as the underlying cause of COPD. 4. Other respiratory disorders: Participants with active tuberculosis, lung cancer, and clinically significant: bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary diseases. 5. Lung resection: Participants who have undergone lung volume reduction surgery within the 12 months prior to Screening. 6. Risk Factors for Pneumonia: immune suppression (e.g. advanced human immunodeficiency virus [HIV] with high viral load and low CD4 count, lupus on immunosuppressants) that in the opinion of the investigator would increase risk of pneumonia or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson’s Disease, Myasthenia Gravis). Participants at potentially high risk for pneumonia (e.g. very low body mass index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator. 7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). 8. Respiratory tract infection that has not resolved at least 7 days prior to Screening. 9. Abnormal Chest x-ray: Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest X-ray (e.g. significant cardiomegaly, pleural effusion or scarring). All participants will have a chest X-ray at Screening Visit 1 (or historical radiograph or computerized tomography [CT] scan obtained within 3 months prior to screening). Note: Participants who have experienced pneumonia and/or moderate or severe COPD exacerbations within 3 months of screening must provide a post pneumonia/exacerbation chest X-ray or have a chest X-ray conducted at Screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (BfS). 10. Other diseases/abnormalities: Participants with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. 11. Unstable liver disease: ALT >2x Upper Limit of Normal (ULN); and bilirubin >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %) Current active liver or biliary disea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of single inhaler triple therapy (FF/UMEC/VI) compared to multiple inhaler triple combination therapy with budesonide/formoterol plus tiotropium after 12 weeks of treatment on lung function. ;Secondary Objective: To evaluate the effects of single inhaler triple therapy (FF/UMEC/VI) compared to multiple inhaler triple combination therapy with budesonide/formoterol plus tiotropium after 12 weeks of treatment on Health Status. To evaluate the effects of single inhaler triple therapy (FF/UMEC/VI) compared to multiple inhaler triple combination therapy with budesonide/formoterol plus tiotropium after 12 weeks of treatment on COPD exacerbations. Assess how inspiratory airflow limitation affects ability to use the ELLIPTA To evaluate the safety profile of single inhaler triple therapy (FF/UMEC/VI) compared to multiple inhaler triple combination therapy with budesonide/formoterol plus tiotropium over 84 days of treatment ;Primary end point(s): Weighted mean change from baseline in FEV1 over 0-24 hours at Week 12 ;Timepoint(s) of evaluation of this end point: For the timepoints of evaluation of endpoints please refer to section E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points - Change from baseline in trough FEV1 on Day 2, Day 28, Day 84 and Day 85 - Weighted mean change from baseline in FEV1 over 0-24 hours on Day 1 Other end points - Proportion of responders based on the St George’s Respiratory Questionnaire (SGRQ) Total Score at Week 4 and Week 12 - Change from baseline in SGRQ Total Score at Week 4 and Week 12 - Proportion of responders based on the COPD Assessment Test (CAT) Total Score at Week 4 and Week 12 - Change from baseline in CAT Total Score at Week 4 and Week 12 - Moderate or severe exacerbation event - Peak Inspiratory Flow Rate (PIFR) at Screening (Week -4) Safety end points - Incidence of adverse events - Vital signs ;Timepoint(s) of evaluation of this end point: For the timepoints of evaluation of endpoints please refer to section E.5.2 | — |
Countries
Czech Republic, Germany, Portugal, United States
Contacts
Public ContactClinical Trials Helpdesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed