Trial Outcomes & Findings for Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents (NCT NCT01431950)
NCT ID: NCT01431950
Last Updated: 2017-01-09
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.
COMPLETED
PHASE3
238 participants
Baseline and Week 24
2017-01-09
Participant Flow
Participants meeting eligibility criteria at the Screening visit entered a 4-week Run-in Period for Baseline safety evaluations and to obtain measures of asthma status. Participants were then randomized to a 24-week Treatment Period. A total of 500 participants were screened; 239 were randomized, and 238 received \>=1 dose of study treatment.
Participant milestones
| Measure |
FF 100 µg OD
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
119
|
|
Overall Study
COMPLETED
|
100
|
104
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
Reasons for withdrawal
| Measure |
FF 100 µg OD
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Overall Study
Study Site Closed/Terminated
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Met Protocol-defined Stopping Criteria
|
0
|
1
|
Baseline Characteristics
Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
Baseline characteristics by cohort
| Measure |
FF 100 µg OD
n=119 Participants
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
n=119 Participants
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 15.41 • n=5 Participants
|
45.1 Years
STANDARD_DEVIATION 15.78 • n=7 Participants
|
45.9 Years
STANDARD_DEVIATION 15.58 • n=5 Participants
|
|
Gender
Female
|
81 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Gender
Male
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage (HER)
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian HER
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian HER /South East Asian HER
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native & White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received \>=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice \[GCP\] issues identified during a site audit). Only those par. with non-missing covariates and post-Baseline FEV1 data were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.
Outcome measures
| Measure |
FF 100 µg OD
n=106 Participants
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
n=109 Participants
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
|
0.208 Liters
Standard Error 0.0417
|
0.284 Liters
Standard Error 0.0411
|
SECONDARY outcome
Timeframe: From Baseline up to Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
FF 100 µg OD
n=108 Participants
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
n=109 Participants
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period
|
21.3 Percentage of rescue-free 24-hr periods
Standard Error 3.05
|
23.1 Percentage of rescue-free 24-hr periods
Standard Error 3.03
|
SECONDARY outcome
Timeframe: From Baseline up to Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
FF 100 µg OD
n=108 Participants
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
n=109 Participants
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period
|
5.9 Liters/minute (L/min)
Standard Error 3.26
|
7.2 Liters/minute (L/min)
Standard Error 3.25
|
SECONDARY outcome
Timeframe: From Baseline up to Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
FF 100 µg OD
n=108 Participants
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
n=109 Participants
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period
|
13.4 L/min
Standard Error 3.22
|
13.2 L/min
Standard Error 3.20
|
SECONDARY outcome
Timeframe: From Baseline up to Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
FF 100 µg OD
n=108 Participants
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
n=109 Participants
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period
|
17.5 Percentage of symptom-free 24-hr periods
Standard Error 2.80
|
19.6 Percentage of symptom-free 24-hr periods
Standard Error 2.79
|
Adverse Events
FF 100 µg OD
FF 200 µg OD
Serious adverse events
| Measure |
FF 100 µg OD
n=119 participants at risk
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
n=119 participants at risk
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Abscess
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Acute sinusitis
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.84%
1/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
Other adverse events
| Measure |
FF 100 µg OD
n=119 participants at risk
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 200 µg OD
n=119 participants at risk
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.8%
14/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
12.6%
15/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
11.8%
14/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
6.7%
8/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
4.2%
5/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
6.7%
8/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
6.7%
8/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
4.2%
5/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
5.9%
7/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
3.4%
4/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
5.9%
7/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
10.1%
12/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
12.6%
15/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
3/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
4.2%
5/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.2%
5/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
1.7%
2/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
4/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
3.4%
4/119 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- 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.
- Publication restrictions are in place
Restriction type: OTHER