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INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

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ClinicalTrials.gov Identifier: NCT03467425
Recruitment Status : Completed
First Posted : March 16, 2018
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: FF/UMEC/VI
Drug: Inhaled Corticosteroid
Drug: LAMA
Drug: LABA
Drug: COPD rescue medications
Enrollment 3109
Recruitment Details This was a Phase IV, open-label, randomized study to evaluate the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA multiple inhaler triple therapies (MITT) for chronic obstructive pulmonary disease (COPD) control within the usual clinical practice setting. TRELEGY and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
Pre-assignment Details A total of 3341 participants were screened and 3109 participants (Par.) were enrolled in this study. Of which, 3092 participants were randomized and received the study treatment. The remaining 17 participants were randomized in error (those who were recorded as screen failures and also randomized) and did not receive investigational product (IP).
Arm/Group Title FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT
Hide Arm/Group Description Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
Period Title: Overall Study
Started 1545 1547
Randomized But Did Not Start IP 1 0
Completed IP 1256 1359
Not Completed IP 288 188
Withdrew IP (WIP): Lost to Follow-up 15 24
WIP: Protocol Deviation 0 2
WIP: Adverse Event 112 29
WIP: Lack of Efficacy 56 28
WIP: Physician Decision 14 27
WIP: Withdrawal by Participant 91 78
Completed 1498 1493
Not Completed 47 54
Reason Not Completed
Adverse Event             9             9
Lack of Efficacy             3             1
Protocol Violation             0             1
Lost to Follow-up             18             25
Physician Decision             2             1
Withdrawal by Subject             15             17
Arm/Group Title FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT Total
Hide Arm/Group Description Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. Total of all reporting groups
Overall Number of Baseline Participants 1545 1547 3092
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1545 participants 1547 participants 3092 participants
67.8  (8.78) 67.8  (8.59) 67.8  (8.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1545 participants 1547 participants 3092 participants
Female
708
  45.8%
729
  47.1%
1437
  46.5%
Male
837
  54.2%
818
  52.9%
1655
  53.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1545 participants 1547 participants 3092 participants
Asian- Central/South Asian Heritage
12
   0.8%
7
   0.5%
19
   0.6%
Asian- East Asian Heritage
0
   0.0%
1
   0.1%
1
   0.0%
Asian- South East Asian Heritage
1
   0.1%
6
   0.4%
7
   0.2%
Black or African American
3
   0.2%
4
   0.3%
7
   0.2%
White- Arabic/North African Heritage
6
   0.4%
7
   0.5%
13
   0.4%
White- White/Caucasian/European Heritage
1523
  98.6%
1521
  98.3%
3044
  98.4%
White and Black or African American
0
   0.0%
1
   0.1%
1
   0.0%
1.Primary Outcome
Title Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24
Hide Description The CAT is a 8-item questionnaire, used to measure the health status of par. with COPD. Par. rated their experience on a 6-point scale: 0 (no impact) to 5 (maximum impact). CAT score was calculated by summing the non-missing scores of the 8 items with a range of 0-40. Higher scores indicate greater disease impact. Responders were par. who had a change from Baseline score >=2 at Week 24. Non-responders were the par. who had change from Baseline score <2 at Week 24. Change from Baseline was calculated as Week 24 value minus the Baseline value (Day 1). A composite strategy was applied when intercurrent events of randomized treatment modification, change in pulmonary rehabilitation or start of oxygen therapy occurred, otherwise a treatment policy strategy was applied. Missing Week 24 CAT data were imputed assuming missing at random and are presented in a separate category. Number of responders, non-responders based on CAT and par. with imputed CAT score at Week 24 are presented.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population comprised of all randomized participants (any participant who received a randomization number), excluding those who were randomized in error (a screen failure and also randomized). Only those participants with non-missing covariates were included in the analysis
Arm/Group Title FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT
Hide Arm/Group Description:
Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
Overall Number of Participants Analyzed 1539 1543
Measure Type: Count of Participants
Unit of Measure: Participants
Responders
731
  47.5%
616
  39.9%
Non-responders
756
  49.1%
835
  54.1%
Participants with imputed CAT score
52
   3.4%
92
   6.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI, Non-ELLIPTA MITT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Analysis was performed using logistic regression model with covariates of treatment group, Baseline CAT score, number of exacerbations in the prior year, actual prior medication use strata and country.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
1.13 to 1.51
Estimation Comments Statistical comparison is presented for combined data of responders, non-responders and those with imputed CAT score at Week 24.
2.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Hide Description FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were collected using a spirometer. Baseline was defined as the value recorded at Day 1. Change from Baseline was calculated as FEV1 value at Week 24 minus the Baseline value. A treatment policy strategy was used for the intercurrent events of randomized treatment discontinuation, randomized treatment modification, change of pulmonary rehabilitation status and start of oxygen therapy. Only those participants with non-missing covariates were included in the analysis.
Time Frame Baseline (Day 1) and at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FEV1 Population comprised of all participants of the ITT population for whom a spirometry assessment was performed at any of Visit 1 (Day 1) or Visit 2 (Week 24). Only those participants with data available at the specified data points were analyzed.
Arm/Group Title FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT
Hide Arm/Group Description:
Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
Overall Number of Participants Analyzed 691 675
Least Squares Mean (Standard Error)
Unit of Measure: Liters
1.446  (0.0105) 1.396  (0.0108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI, Non-ELLIPTA MITT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.050
Confidence Interval (2-Sided) 95%
0.026 to 0.073
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0121
Estimation Comments Analysis was performed using an ANCOVA with covariates of treatment group, Baseline FEV1, actual prior medication use strata, country and timing of spirometry.
3.Secondary Outcome
Title Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24
Hide Description Participants were trained on the correct use of their inhaler devices. All participants who had spirometry measured were to have an assessment of inhaler errors. During the assessment, participants were asked to demonstrate inhaler use when taking their regular dose of medication. A critical error is defined as an error that is most likely to result in no or significantly reduced medication being inhaled. These errors were recorded in an error checklist, during the assessment. A hypothetical strategy was used for the intercurrent event of randomized treatment modification. Percentage of participants making at least 1 critical error in inhalation technique at the Week 24 is presented.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Critical error Population comprised of all participants of the ITT population for whom a critical error assessment was performed at Visit 2 (Week 24). Only those participants with data available at the specified data points were analyzed.
Arm/Group Title FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT
Hide Arm/Group Description:
Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
Overall Number of Participants Analyzed 653 230
Measure Type: Number
Unit of Measure: Percentage of Participants
6 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI, Non-ELLIPTA MITT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
0.87 to 4.53
Estimation Comments Analysis was performed using logistic regression model with covariates of treatment group, actual prior medication use strata and country.
Time Frame Serious adverse events (SAEs) and non-serious AEs (non-SAEs) were collected from the start of study treatment up to Week 24
Adverse Event Reporting Description Data is reported for the ITT Population which comprised of all randomized participants (who received a randomization number), excluding those who were randomized in error. All SAEs were collected. Non-SAEs which were only drug-related or that lead to withdrawal from study/study treatment were collected.
 
Arm/Group Title FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-Ellipta MITT
Hide Arm/Group Description Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
All-Cause Mortality
FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-Ellipta MITT
Affected / at Risk (%) Affected / at Risk (%)
Total   8/1545 (0.52%)      8/1547 (0.52%)    
Hide Serious Adverse Events
FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-Ellipta MITT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   114/1545 (7.38%)      114/1547 (7.37%)    
Blood and lymphatic system disorders     
Anaemia  1  0/1545 (0.00%)  0 1/1547 (0.06%)  2
Cardiac disorders     
Acute myocardial infarction  1  5/1545 (0.32%)  5 5/1547 (0.32%)  5
Cardiac failure  1  3/1545 (0.19%)  3 7/1547 (0.45%)  7
Atrial fibrillation  1  4/1545 (0.26%)  4 5/1547 (0.32%)  5
Myocardial infarction  1  5/1545 (0.32%)  5 2/1547 (0.13%)  2
Acute coronary syndrome  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Angina pectoris  1  2/1545 (0.13%)  2 0/1547 (0.00%)  0
Coronary artery disease  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Aortic valve stenosis  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Atrial flutter  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Cardiac arrest  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Cardiac asthma  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Cardiac failure chronic  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Cardiogenic shock  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Cor pulmonale  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Left ventricular failure  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Ventricular hypokinesia  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Ventricular tachycardia  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Ear and labyrinth disorders     
Vestibular disorder  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Eye disorders     
Diplopia  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Gastrointestinal disorders     
Diverticulum intestinal  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Colitis  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Constipation  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Duodenal ulcer  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Enterocolitis  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Gastrointestinal polyp haemorrhage  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Incarcerated umbilical hernia  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Large intestine perforation  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Large intestine polyp  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Pancreatitis acute  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Rectal haemorrhage  1  0/1545 (0.00%)  0 1/1547 (0.06%)  2
Small intestinal haemorrhage  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
General disorders     
Chest pain  1  0/1545 (0.00%)  0 2/1547 (0.13%)  2
Non-cardiac chest pain  1  0/1545 (0.00%)  0 2/1547 (0.13%)  2
Death  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
General physical health deterioration  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Multiple organ dysfunction syndrome  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Sudden death  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Infections and infestations     
Pneumonia  1  26/1545 (1.68%)  27 30/1547 (1.94%)  30
Infective exacerbation of chronic obstructive airways disease  1  6/1545 (0.39%)  6 9/1547 (0.58%)  9
Sepsis  1  3/1545 (0.19%)  3 2/1547 (0.13%)  2
Cellulitis  1  2/1545 (0.13%)  2 0/1547 (0.00%)  0
Urosepsis  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Corynebacterium infection  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Erysipelas  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Gastrointestinal viral infection  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Haemophilus infection  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Influenza  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Lower respiratory tract infection  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Necrotising fasciitis  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Pneumonia haemophilus  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Pneumonia pneumococcal  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Pyelonephritis  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Respiratory syncytial virus bronchiolitis  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Respiratory tract infection  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Urinary bladder abscess  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Urinary tract infection  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Injury, poisoning and procedural complications     
Fall  1  2/1545 (0.13%)  2 3/1547 (0.19%)  3
Humerus fracture  1  2/1545 (0.13%)  2 1/1547 (0.06%)  1
Ankle fracture  1  2/1545 (0.13%)  2 0/1547 (0.00%)  0
Femoral neck fracture  1  0/1545 (0.00%)  0 2/1547 (0.13%)  2
Femur fracture  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Alcohol poisoning  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Injury  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Overdose  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Rib fracture  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Skin laceration  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Spinal fracture  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Toxicity to various agents  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Wound  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Investigations     
Blood glucose increased  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Metabolism and nutrition disorders     
Fluid retention  1  0/1545 (0.00%)  0 1/1547 (0.06%)  2
Hypokalaemia  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Hypomagnesaemia  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Hyponatraemia  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Shock hypoglycaemic  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Osteoarthritis  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Osteolysis  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Rhabdomyolysis  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/1545 (0.06%)  1 2/1547 (0.13%)  2
Lung neoplasm malignant  1  1/1545 (0.06%)  1 2/1547 (0.13%)  2
Prostate cancer  1  1/1545 (0.06%)  1 2/1547 (0.13%)  2
Oesophageal carcinoma  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Small cell lung cancer  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Basal cell carcinoma  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Breast cancer metastatic  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Hodgkin's disease  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Lung squamous cell carcinoma stage II  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Mesothelioma  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Non-small cell lung cancer metastatic  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Pancreatic carcinoma  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Pituitary tumour benign  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Pleural mesothelioma  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Small cell lung cancer limited stage  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
T-cell lymphoma stage IV  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Nervous system disorders     
Cerebrovascular accident  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Syncope  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Brain stem infarction  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Cerebral venous thrombosis  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Dizziness  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Peroneal nerve palsy  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Presyncope  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Reversible ischaemic neurological deficit  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Sensory loss  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Renal and urinary disorders     
Renal failure  1  0/1545 (0.00%)  0 2/1547 (0.13%)  2
Bladder perforation  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Dysuria  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Nephrolithiasis  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  26/1545 (1.68%)  28 28/1547 (1.81%)  29
Pleural effusion  1  0/1545 (0.00%)  0 4/1547 (0.26%)  4
Respiratory failure  1  3/1545 (0.19%)  4 1/1547 (0.06%)  1
Dyspnoea  1  1/1545 (0.06%)  1 2/1547 (0.13%)  2
Pulmonary embolism  1  3/1545 (0.19%)  3 0/1547 (0.00%)  0
Acute respiratory failure  1  0/1545 (0.00%)  0 2/1547 (0.13%)  2
Pulmonary oedema  1  1/1545 (0.06%)  1 1/1547 (0.06%)  1
Pneumonia aspiration  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Pneumothorax  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Vascular disorders     
Peripheral arterial occlusive disease  1  2/1545 (0.13%)  2 1/1547 (0.06%)  1
Peripheral ischaemia  1  1/1545 (0.06%)  1 2/1547 (0.13%)  2
Hypertensive crisis  1  2/1545 (0.13%)  2 0/1547 (0.00%)  0
Deep vein thrombosis  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
Iliac artery occlusion  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Peripheral artery occlusion  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Shock haemorrhagic  1  1/1545 (0.06%)  1 0/1547 (0.00%)  0
Varicose vein  1  0/1545 (0.00%)  0 1/1547 (0.06%)  1
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-Ellipta MITT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/1545 (2.07%)      3/1547 (0.19%)    
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  32/1545 (2.07%)  32 3/1547 (0.19%)  3
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03467425    
Other Study ID Numbers: 206854
2017-004369-29 ( EudraCT Number )
First Submitted: February 2, 2018
First Posted: March 16, 2018
Results First Submitted: August 19, 2020
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020