Trial Outcomes & Findings for A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD (NCT NCT01336608)

Last Updated: 2017-11-08

Results Overview

PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young's modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

446 participants

Primary outcome timeframe

BL to Day 168

Results posted on

2017-11-08

Participant Flow

A total of 3011 participants (par.) were screened, 559 entered the Run-in Period (RIP), of whom 444 were randomized and received at least one dose of study medication; 430 of these were included in the Intent-to-Treat (ITT) Population.

Eligible par. at screening entered a 2-week, single-blind placebo RIP to obtain albuterol (salbutamol) use at Baseline, and to ensure that par.'s COPD was stable at randomization. At the end of the RIP, par. meeting the randomization criteria entered the double-blind treatment period (TP) of 24 weeks (Wk).

Participant milestones

Participant milestones
Measure	Placebo-Run-in Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler \[MDI\] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.	Placebo QD Participants received placebo QD in the morning via a dry powder inhaler (DPI) for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	VI 25 µg QD Participants received vilanterol (VI) 25 micrograms (µg) inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	FF/VI 100/25 µg QD Participants received fluticasone furoate (FF)/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
2-week, Single-blind Run-In Period STARTED	559	0	0	0
2-week, Single-blind Run-In Period COMPLETED	444	0	0	0
2-week, Single-blind Run-In Period NOT COMPLETED	115	0	0	0
24-week, Double-blind Treatment Period STARTED	0	141	154	135
24-week, Double-blind Treatment Period Completed the Treatment Period	0	96	124	110
24-week, Double-blind Treatment Period COMPLETED	0	97	124	111
24-week, Double-blind Treatment Period NOT COMPLETED	0	44	30	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo-Run-in Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler \[MDI\] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.	Placebo QD Participants received placebo QD in the morning via a dry powder inhaler (DPI) for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	VI 25 µg QD Participants received vilanterol (VI) 25 micrograms (µg) inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	FF/VI 100/25 µg QD Participants received fluticasone furoate (FF)/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
2-week, Single-blind Run-In Period Did Not Meet Continuation Criteria	102	0	0	0
2-week, Single-blind Run-In Period Withdrawal by Subject	9	0	0	0
2-week, Single-blind Run-In Period Adverse Event	1	0	0	0
2-week, Single-blind Run-In Period Physician Decision	1	0	0	0
2-week, Single-blind Run-In Period Lost to Follow-up	2	0	0	0
24-week, Double-blind Treatment Period Adverse Event	0	8	6	7
24-week, Double-blind Treatment Period Lack of Efficacy-No Sub-Reason	0	2	0	0
24-week, Double-blind Treatment Period Lack of Efficacy-Sub-Reason Exacerbation	0	13	13	6
24-week, Double-blind Treatment Period Protocol Violation	0	4	3	3
24-week, Double-blind Treatment Period Protocol-defined Stopping Criteria	0	4	3	6
24-week, Double-blind Treatment Period Lost to Follow-up	0	3	0	0
24-week, Double-blind Treatment Period Physician Decision	0	3	1	1
24-week, Double-blind Treatment Period Withdrawal by Subject	0	7	4	1

Baseline Characteristics

A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo QD n=141 Participants Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	VI 25 µg QD n=154 Participants Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	FF/VI 100/25 µg QD n=135 Participants Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	Total n=430 Participants Total of all reporting groups
Age, Continuous	68.2 Years STANDARD_DEVIATION 8.10 • n=5 Participants	68.7 Years STANDARD_DEVIATION 7.69 • n=7 Participants	68.5 Years STANDARD_DEVIATION 8.01 • n=5 Participants	68.5 Years STANDARD_DEVIATION 7.91 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	36 Participants n=7 Participants	31 Participants n=5 Participants	89 Participants n=4 Participants
Sex: Female, Male Male	119 Participants n=5 Participants	118 Participants n=7 Participants	104 Participants n=5 Participants	341 Participants n=4 Participants
Race/Ethnicity, Customized African American/African Heritage	7 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	21 Participants n=5 Participants	23 Participants n=7 Participants	18 Participants n=5 Participants	62 Participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	45 Participants n=5 Participants	51 Participants n=7 Participants	47 Participants n=5 Participants	143 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Mixed Race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	64 Participants n=5 Participants	75 Participants n=7 Participants	64 Participants n=5 Participants	203 Participants n=4 Participants
Race/Ethnicity, Customized Mixed Race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: BL to Day 168

Population: 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.

Outcome measures

Outcome measures
Measure	VI 25 µg QD n=117 Participants Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	FF/VI 100/25 µg QD n=103 Participants Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	Placebo QD n=85 Participants Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)	-1.95 meters per second (m/sec) Standard Error 0.241	-1.75 meters per second (m/sec) Standard Error 0.256	-1.97 meters per second (m/sec) Standard Error 0.279

SECONDARY outcome

Timeframe: BL to Day 168

Population: ITT Population. 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.

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 at Screening, Days 1, 28, 84, 126, and 168. BL FEV1 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 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was preformed using a repeated measures model with covariates of visit, treatment, history of exacerbation strata, geographical region, BL FEV1 and interaction terms of BL by visit and treatment by visit.

Outcome measures

Outcome measures
Measure	VI 25 µg QD n=123 Participants Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	FF/VI 100/25 µg QD n=111 Participants Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	Placebo QD n=96 Participants Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168	0.033 Liters (L) Standard Error 0.0202	0.106 Liters (L) Standard Error 0.0210	-0.049 Liters (L) Standard Error 0.0221

SECONDARY outcome

Timeframe: BL (Week -1), Week 1 to Week 24

Population: ITT Population: all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.

Participants were given daily record cards for daily completion from BL (Week -1) through Week 24 (Visit 6) each morning and prior to taking study medication (i.e., single-blind and double-blind study medication) supplemental medication (albuterol \[salbutamol\] if received) and ipratropium bromide (if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Analysis was performed using an analysis of covarience (ANCOVA) model with covariates of treatment, BL mean of occasions of rescue medication use (Week -1), history of exacerbation, and geographical region.

Outcome measures

Outcome measures
Measure	VI 25 µg QD n=152 Participants Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	FF/VI 100/25 µg QD n=135 Participants Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	Placebo QD n=139 Participants Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period	1.50 Occasions per 24 hours Standard Error 0.089	1.47 Occasions per 24 hours Standard Error 0.095	1.97 Occasions per 24 hours Standard Error 0.093

Adverse Events

Placebo QD

Serious events: 5 serious events

Other events: 24 other events

Deaths: 0 deaths

VI 25 µg QD

Serious events: 12 serious events

Other events: 27 other events

Deaths: 0 deaths

FF/VI 100/25 µg QD

Serious events: 9 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo QD n=145 participants at risk Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	VI 25 µg QD n=158 participants at risk Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.	FF/VI 100/25 µg QD n=141 participants at risk Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
Infections and infestations Nasopharyngitis	3.4% 5/145 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	7.6% 12/158 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	6.4% 9/141 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.
Infections and infestations Oral candidiasis	0.69% 1/145 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	1.3% 2/158 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	6.4% 9/141 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.
Infections and infestations Upper respiratory tract infection	4.1% 6/145 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	2.5% 4/158 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	1.4% 2/141 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 4/145 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	0.63% 1/158 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	3.5% 5/141 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.
Musculoskeletal and connective tissue disorders Back pain	3.4% 5/145 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	3.2% 5/158 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	2.8% 4/141 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.
Nervous system disorders Headache	3.4% 5/145 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	5.7% 9/158 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	5.7% 8/141 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.69% 1/145 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	1.3% 2/158 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.	4.3% 6/141 • On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]). SAEs and non-serious AEs reported for par. of the Safety Population (Pop) comprised of ITT Pop plus par. from the excluded site who qualified for the ITT Pop. On-treatment AE or SAE is defined as an AE with an onset date on or after the start date of DB study medication, but not later than one day after the last dose of DB study medication.

Additional Information

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Principal investigator is a sponsor employee 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.
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