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

Participant Flow

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
Arm/Group Description	Eligible participants received a co...	Eligible participants received the ...
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

Baseline Characteristics

Arm/Group Title		FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI	Non-ELLIPTA MITT	Total
Arm/Group Description		Eligible participants received a co...	Eligible participants received the ...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

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
Description	The CAT is a 8-item questionnaire, used to measure the health status o...
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

Outcome Measure Data

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
Arm/Group Description:	Eligible participants received a co...	Eligible participants received the ...
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%

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
Description	FEV1 is a measure of lung function and is defined as the maximal amoun...
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

Outcome Measure Data

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
Arm/Group Description:	Eligible participants received a co...	Eligible participants received the ...
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)

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
Description	Participants were trained on the correct use of their inhaler devices....
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

Outcome Measure Data

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
Arm/Group Description:	Eligible participants received a co...	Eligible participants received the ...
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

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.

Adverse Events

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
Arm/Group Description	Eligible participants received a co...		Eligible participants received the ...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

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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

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Name/Title:	GSK Response Center
Organization:	GlaxoSmithKline
Phone:	866-435-7343
EMail:	GSKClinicalSupportHD@gsk.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Worsley S, Snowise N, Halpin DMG, Midwinter D, Ismaila AS, Irving E, Sansbury L, Tabberer M, Leather D, Compton C. Clinical effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol in usual practice: the COPD INTREPID study design. ERJ Open Res. 2019 Nov 4;5(4). pii: 00061-2019. doi: 10.1183/23120541.00061-2019. eCollection 2019 Oct.

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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

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