A 6-month Study to Evaluate the Efficacy and Safety of Fl... | NCT01053988

Label	Type	Description	Intervention Names
FF/GW642444 Inhalation Powder	Experimental	Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)	Drug: FF/GW642444 Inhalation Powder
FF Inhalation Powder	Experimental	Inhaled Corticosteroid (ICS)	Drug: FF Inhalation Powder
GW642444 Inhalation Powder	Experimental	Long Acting Beta Agonist(LABA)	Drug: GW642444 Inhalation Powder
Placebo	Placebo Comparator	Placebo	Drug: Placebo
FF/GW642444 Inhalation Pwdr	Experimental	Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)	Drug: FF/GW642444 Inhalation Powder

Name	Type	Description	Arm Group Labels	Other Names
FF/GW642444 Inhalation Powder	Drug	Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD	FF/GW642444 Inhalation Powder FF/GW642444 Inhalation Pwdr

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168	Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.	Baseline (BL) to Day 168
Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169	Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.	Baseline to Day 169

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168	Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type of subject: outpatient
Informed consent: Subjects must give their signed and dated written informed consent to participate.
Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of:
Non-child bearing potential OR
Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods defined in the protocol
Age: ≥40 years of age at Screening (Visit 1)
COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]
Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1).
Severity of Disease: Subjects with a Screening (Visit 1) measured post-albuterol/salbutamol:
FEV1/FVC ratio of ≤0.70 and
FEV1 ≤70% of predicted normal values
Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Screening (Visit 1).

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Asthma: Subjects with a current diagnosis of asthma
α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)
Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1.
Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medication or components of the inhalation powder
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium 4 hours prior to spirometry testing at each study visit
Additional medication: Use of certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ≤12 hours per day) is not exclusionary.
Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
Prior use of study medication/other investigational drugs
Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Mobile	Alabama	36608	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
23352226	Background	Kerwin EM, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N, Crim C. A randomised trial of fluticasone furoate/vilanterol (50/25 mug; 100/25 mug) on lung function in COPD. Respir Med. 2013 Apr;107(4):560-9. doi: 10.1016/j.rmed.2012.12.014. Epub 2013 Jan 23.
40536286	Derived	Yang L, Llanos-Paez C, Yang S, Ambery C, Berges A, Kjellsson MC, Karlsson MO. A Combined Model-Based Meta-Analysis of Aggregated and Individual FEV1 Data From Randomized COPD Trials. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70059. doi: 10.1002/psp4.70059. Epub 2025 Jun 19.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
112206	Individual Participant Data Set	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo Run-in	Participants received placebo once daily (OD) in the morning for 2 weeks.
FG001	Placebo	Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168

Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.

Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis

Posted

Least Squares Mean

Standard Error

Liters

Baseline (BL) to Day 168

ID	Title	Description
OG000	Placebo	Participants received placebo OD in the morning from the DPI for 24 weeks.
OG001	FF 100 µg OD	Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
OG002	VI 25 µg OD	Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
OG003	FF/VI 50/25 µg OD	Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
OG004	FF/VI 100/25 µg OD	Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.

Units	Counts
Participants	OG000139 OG001145 OG002144 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.026± 0.0184 OG0010.080± 0.0182 OG0020.129± 0.0182 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).	0.040	Nominal p-value	Least squares mean difference	0.053			2-Sided	95	0.003	0.104					Superiority or Other
OG000 OG002

Primary

Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169

Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.

Posted

Least Squares Mean

Standard Error

Liters

Baseline to Day 169

ID	Title	Description
OG000	Placebo	Participants received placebo OD in the morning from the DPI for 24 weeks.
OG001	FF 100 µg OD

Secondary

Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168

Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline to Day 168

ID	Title	Description
OG000	Placebo	Participants received placebo OD in the morning from the DPI for 24 weeks.

Secondary

Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1

Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.

Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.

Posted

Least Squares Mean

Standard Error

Liters

Baseline and Day 1

ID	Title	Description
OG000	Placebo	Participants received placebo OD in the morning from the DPI for 24 weeks.
OG001	FF 100 µg OD	Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.

Secondary

Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1

Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.

Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.

Posted

Median

Full Range

Minutes

Baseline and Day 1

ID	Title	Description
OG000	Placebo	Participants received placebo OD in the morning from the DPI for 24 weeks.
OG001	FF 100 µg OD	Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
OG002	VI 25 µg OD

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected207 at risk EG0012 affected206 at risk EG0026 affected205 at risk EG0030 affected206 at risk EG004
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0012 affected206 at risk EG0023 affected205 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0021 affected205 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0021 affected205 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Transplant failure	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0012 affected206 at risk EG0020 affected205 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Hypertonia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0021 affected205 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Glottis carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0021 affected205 at risk EG003
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0021 affected205 at risk EG003
Nasopharyngeal cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Sudden cardiac death	General disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0021 affected205 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0021 affected205 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003
Deafness neurosensory	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0011 affected206 at risk EG0020 affected205 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected207 at risk EG0010 affected206 at risk EG0020 affected205 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00014 affected207 at risk EG00118 affected206 at risk EG00222 affected205 at risk EG00314 affected206 at risk EG00422 affected206 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected207 at risk EG00113 affected206 at risk EG00211 affected205 at risk EG003
Oropharyngeal candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected207 at risk EG0014 affected206 at risk EG0022 affected205 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected207 at risk EG0012 affected206 at risk EG0023 affected205 at risk EG003
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected207 at risk EG0017 affected206 at risk EG0023 affected205 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected207 at risk EG0011 affected206 at risk EG0024 affected205 at risk EG003
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected207 at risk EG00117 affected206 at risk EG00216 affected205 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected207 at risk EG0015 affected206 at risk EG0027 affected205 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected207 at risk EG0017 affected206 at risk EG0022 affected205 at risk EG003

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Placebo	Participants received placebo OD in the morning from the DPI for 24 weeks.
BG001	FF 100 µg OD	Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
BG002	VI 25 µg OD	Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
BG003	FF/VI 50/25 µg OD	Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
BG004	FF/VI 100/25 µg OD	Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
BG005	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo OD in the morning from the DPI for 24 weeks.	11	207	37	207
EG001	FF 100 µg OD	Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	16	206	59	206
EG002	VI 25 µg OD	Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	15	205	53	205
EG003	FF/VI 50/25 µg OD	Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.	6	206	52	206
EG004	FF/VI 100/25 µg OD	Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	11	206	63	206