Trial Outcomes & Findings for Asthma Exacerbation Study (NCT NCT01086384)
NCT ID: NCT01086384
Last Updated: 2018-01-24
Results Overview
Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second \[FEV1, maximum amount of air forcefully exhaled in one second\]), sex, age, and region.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2020 participants
Primary outcome timeframe
Baseline to Follow-up (up to 76 weeks of treatment)
Results posted on
2018-01-24
Participant Flow
Participants (par.) who met all entry criteria at Screening entered a 2-week Run-in Period for completion of Baseline safety evaluations and to obtain Baseline measures of asthma status. Participants who met continuation criteria at the end of the Run-in Period were randomized to receive study treatment.
Participant milestones
| Measure |
FP 250 µg/ICS
Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
|
FF 100 µg
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
FF/VI 100/25 µg
Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
|---|---|---|---|
|
2-week Run-in Period
STARTED
|
2183
|
0
|
0
|
|
2-week Run-in Period
COMPLETED
|
2020
|
0
|
0
|
|
2-week Run-in Period
NOT COMPLETED
|
163
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
1011
|
1009
|
|
Treatment Period
COMPLETED
|
0
|
863
|
885
|
|
Treatment Period
NOT COMPLETED
|
0
|
148
|
124
|
Reasons for withdrawal
| Measure |
FP 250 µg/ICS
Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
|
FF 100 µg
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
FF/VI 100/25 µg
Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
|---|---|---|---|
|
2-week Run-in Period
Adverse Event
|
1
|
0
|
0
|
|
2-week Run-in Period
Protocol Violation
|
1
|
0
|
0
|
|
2-week Run-in Period
Lost to Follow-up
|
1
|
0
|
0
|
|
2-week Run-in Period
Physician Decision
|
6
|
0
|
0
|
|
2-week Run-in Period
Withdrawal by Subject
|
19
|
0
|
0
|
|
2-week Run-in Period
Study Closed/Terminated
|
42
|
0
|
0
|
|
2-week Run-in Period
Continuation Criteria Not Met
|
92
|
0
|
0
|
|
2-week Run-in Period
Randomized in Error
|
1
|
0
|
0
|
|
Treatment Period
Withdrawal by Subject
|
0
|
53
|
55
|
|
Treatment Period
Protocol Violation
|
0
|
26
|
17
|
|
Treatment Period
Lack of Efficacy
|
0
|
22
|
13
|
|
Treatment Period
Adverse Event
|
0
|
19
|
15
|
|
Treatment Period
Lost to Follow-up
|
0
|
11
|
9
|
|
Treatment Period
Physician Decision
|
0
|
9
|
6
|
|
Treatment Period
Study Closed/Terminated
|
0
|
7
|
8
|
|
Treatment Period
Protocol-Defined Stopping Criteria
|
0
|
0
|
1
|
|
Treatment Period
Received Treatment in Error
|
0
|
1
|
0
|
Baseline Characteristics
Asthma Exacerbation Study
Baseline characteristics by cohort
| Measure |
FF 100 µg
n=1010 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
FF/VI 100/25 µg
n=1009 Participants
Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
Total
n=2019 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 16.82 • n=5 Participants
|
41.1 Years
STANDARD_DEVIATION 17.10 • n=7 Participants
|
41.7 Years
STANDARD_DEVIATION 16.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
689 Participants
n=5 Participants
|
661 Participants
n=7 Participants
|
1350 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
321 Participants
n=5 Participants
|
348 Participants
n=7 Participants
|
669 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
47 participants
n=5 Participants
|
40 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
79 participants
n=5 Participants
|
78 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
738 participants
n=5 Participants
|
738 participants
n=7 Participants
|
1476 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
104 participants
n=5 Participants
|
108 participants
n=7 Participants
|
212 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Follow-up (up to 76 weeks of treatment)Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication.
Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second \[FEV1, maximum amount of air forcefully exhaled in one second\]), sex, age, and region.
Outcome measures
| Measure |
FF 100 µg
n=1010 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
FF/VI 100/25 µg
n=1009 Participants
Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
|---|---|---|
|
Number of Participants With 1 or More Severe Asthma Exacerbations
|
186 participants
|
154 participants
|
SECONDARY outcome
Timeframe: Baseline to Follow-up (up to 76 weeks of treatment)Population: ITT Population
A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.
Outcome measures
| Measure |
FF 100 µg
n=1010 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
FF/VI 100/25 µg
n=1009 Participants
Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
|---|---|---|
|
Number of Severe Asthma Exacerbations
|
271 Severe asthma exacerbations
|
200 Severe asthma exacerbations
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: ITT Population. Only those participants available at the indicated time point (Week 36) were analyzed.
Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.
Outcome measures
| Measure |
FF 100 µg
n=902 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
FF/VI 100/25 µg
n=926 Participants
Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
|---|---|---|
|
Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36
|
0.265 Liters
Standard Deviation 0.014
|
0.348 Liters
Standard Deviation 0.014
|
Adverse Events
FF 100 µg
Serious events: 29 serious events
Other events: 479 other events
Deaths: 0 deaths
FF/VI 100/25 µg
Serious events: 41 serious events
Other events: 467 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF 100 µg
n=1010 participants at risk
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
FF/VI 100/25 µg
n=1009 participants at risk
Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.89%
9/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
1.1%
11/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.40%
4/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.40%
4/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis bacterial
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Lobar pneumonia
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Otitis media
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT 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)
Breast cancer
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT 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)
Metastases to lung
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT 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)
Osteochondroma
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT 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)
Renal cancer stage I
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT 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)
Renal cell carcinoma
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Nervous system disorders
Radiculopathy
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Cardiac disorders
Tachyarrthmia
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT 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
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Vascular disorders
Diabetic microangiopathy
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Psychiatric disorders
Fear
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.10%
1/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Immune system disorders
Anaphylactic reaction
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.10%
1/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
Other adverse events
| Measure |
FF 100 µg
n=1010 participants at risk
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
FF/VI 100/25 µg
n=1009 participants at risk
Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.0%
131/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
15.4%
155/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.2%
93/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
7.2%
73/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
7.3%
74/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
5.8%
59/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
3.8%
38/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
5.0%
50/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitus
|
3.8%
38/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
4.2%
42/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
4.1%
41/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
2.9%
29/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
17.7%
179/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
18.6%
188/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
64/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
5.5%
55/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
55/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
4.1%
41/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.6%
26/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
3.9%
39/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
26/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
3.3%
33/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
40/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
4.1%
41/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
23/1010
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
3.6%
36/1009
Serious adverse events (SAEs) and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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