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The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilanterol | Experimental | Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks |
|
| Salmeterol | Active Comparator | Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilanterol | Drug | Vilanterol inhalation powder inhaled orally once daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 | FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period | The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Huntington Beach | California | 92647 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24928338 | Derived | Lotvall J, Bateman ED, Busse WW, O'Byrne PM, Woodcock A, Toler WT, Jacques L, Goldfrad C, Bleecker ER. Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids. J Negat Results Biomed. 2014 Jun 13;13(1):9. doi: 10.1186/1477-5751-13-9. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112060 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline, safety evaluations, and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. A total of 583 par. were screened, and 347 were randomized, of which 298 received at least one dose of study treatment.
347 participants (par.) were randomized to treatment; all 347 were included in the Intent-to-Treat (ITT) Population. One par. was not randomized but received treatment in error. This par. was not included in the ITT Population and is thus not captured in the Participant Flow module. This par. is categorized as being enrolled in the study (n=348).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Salmeterol Inhalation Powder |
| Drug |
Salmeterol inhalation powder inhaled orally twice daily for 12 weeks |
|
| Placebo Inhalation Powder NDPI | Drug | Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler |
|
| Placebo Inhalation Powder Diskus | Drug | Placebo inhalation powder inhaled orally twice daily for 12 weeks |
|
| Baseline and Weeks 1-12 |
| Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period | Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | Baseline and Weeks 1-12 |
| Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points | FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point. | Baseline and Week 12 |
| Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | Baseline and Weeks 1-12 |
| Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | Baseline and Weeks 1-12 |
| Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours) | The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored. | Day 1 and Week 12 |
| Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12 | At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often. | Week 4 and Week 12 |
| Orlando |
| Florida |
| 32822 |
| United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Lawrenceville | Georgia | 30046 | United States |
| GSK Investigational Site | Skillman | New Jersey | 08558 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Chester | South Carolina | 29706 | United States |
| GSK Investigational Site | Clinton | South Carolina | 29325 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Gauting | Bavaria | 82131 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Lima | Lima Province | Lima 27 | Peru |
| GSK Investigational Site | San Isidro | Lima region | Lima 27 | Peru |
| GSK Investigational Site | San Miguel | Lima region | Lima 32 | Peru |
| GSK Investigational Site | Callao | Lima | Callao 2 | Peru |
| GSK Investigational Site | Lima | Lima 27 | Peru |
| GSK Investigational Site | Chrzanów | 32-500 | Poland |
| GSK Investigational Site | Krakow | 30-901 | Poland |
| GSK Investigational Site | Krakow | 31-024 | Poland |
| GSK Investigational Site | Krakow | 31-455 | Poland |
| GSK Investigational Site | Lublin | 20-552 | Poland |
| GSK Investigational Site | Dnipropetrovsk | 49027 | Ukraine |
| GSK Investigational Site | Dnipropetrovsk | 49074 | Ukraine |
| GSK Investigational Site | Donetsk | 83099 | Ukraine |
| GSK Investigational Site | Ivano-Frankivsk | 76018 | Ukraine |
| GSK Investigational Site | Kharkiv | 61037 | Ukraine |
| GSK Investigational Site | Kharkiv | 61124 | Ukraine |
| GSK Investigational Site | Kyiv | 03680 | Ukraine |
| GSK Investigational Site | Simferopol | 95043 | Ukraine |
| GSK Investigational Site | Yalta | 98603 | Ukraine |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112060 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112060 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112060 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112060 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112060 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112060 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Vilanteral 25 µg OD | Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
| FG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. |
| BG001 | Vilanteral 25 µg OD | Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
| BG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 | FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment. | Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time point were assessed. | Posted | Least Squares Mean | Standard Error | Liters | Baseline and Week 12 |
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| Secondary | Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period | The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | ITT Population. Only those participants available at the indicated time points were assessed. | Posted | Least Squares Mean | Standard Error | Percentage of rescue-free 24-hr periods | Baseline and Weeks 1-12 |
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| Secondary | Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period | Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | ITT Population. Only those participants available at the indicated time points were assessed. | Posted | Least Squares Mean | Standard Error | Percentage of symptom-free 24-hr periods | Baseline and Weeks 1-12 |
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| Secondary | Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points | FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point. | ITT Population. Only those participants available at the indicated time points were assessed. | Posted | Least Squares Mean | Standard Error | Liters | Baseline and Week 12 |
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| Secondary | Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | ITT Population. Only those participants available at the indicated time points were assessed. | Posted | Least Squares Mean | Standard Error | Liters per minute (L/min) | Baseline and Weeks 1-12 |
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| Secondary | Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | ITT Population. Only those participants available at the indicated time points were assessed. | Posted | Least Squares Mean | Standard Error | Liters per minute (L/min) | Baseline and Weeks 1-12 |
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| Secondary | Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours) | The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored. | ITT Population. Only those participants available at the indicated time points were assessed. | Posted | Number | Participants | Day 1 and Week 12 |
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| Secondary | Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12 | At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often. | ITT Population. Only those participants available at the indicated time points were assessed. | Posted | Number | Participants | Week 4 and Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. | 1 | 116 | 26 | 116 | ||
| EG001 | Vilanteral 25 µg OD | Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. | 1 | 115 | 26 | 115 | ||
| EG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. | 0 | 116 | 21 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death | General disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C550468 | vilanterol |
Not provided
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| Male |
|
| American Indian or Alaska Native |
|
| Japanese/East Asian Heritage |
|
| White |
|
| ANCOVA |
| 0.926 |
P-value for the adjusted treatment difference for Salmetarol 50 µg BID versus Placebo. |
| Mean Difference (Final Values) |
| -0.006 |
| 2-Sided |
| 95 |
| -0.124 |
| 0.113 |
The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Salmeterol 50 µg BID versus Placebo. |
| Superiority or Other |
| OG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
|
|
| OG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
|
|
| OG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
|
|
| OG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
|
|
| OG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
|
|
| OG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
|
|
| OG002 | Salmeterol 50 µg BID | Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. |
|
|