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The primary aim of this study is to clarify the position of FF and FF/Vilanterol (VI) 100/25 micrograms (mcg) compared with existing therapies by assessing FF dosage equivalent to low to middle-dose inhaled corticosteroids (ICS). The study is divided into Run-in period, Period 1 (open-label treatment), Period 2 (double blind treatment) and Follow-up. Subjects with well controlled asthma after completing a run-in period of 4 weeks will be switched from middle-dose ICS/long acting beta 2 agonist (LABA) equivalent dose to once-daily FF/VI 100/25 mcg for an 8 weeks treatment period (Period 1). After this, subjects will be randomized in a 1:1:1 ratio to receive either FP 250 mcg twice daily, FP 100 mcg twice daily or FF 100 mcg once daily in a 12 week double blind treatment period (Period 2). There will be a 1 week Follow-up Period following completion of the double-blind treatment period, or early withdrawal from the study. Overall , the total duration of subject's participation in the study will be for 25 weeks. RELVAR is a registered trademark of the GSK group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 FF/VI 100/25 mcg | Experimental | Subjects will receive Fluticasone Furoate/Vilanterol 100/25 mcg once-daily via a dry powder inhaler for 8 weeks in the open-label treatment period. |
|
| Arm 2 FF 100 mcg | Experimental | Subjects will receive Fluticasone Propionate matching placebo twice-daily (morning and evening) and Fluticasone Furoate 100 mcg once daily in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period |
|
| Arm 3 FP 250 mcg | Experimental | Subjects will receive Fluticasone Propionate 250 mcg twice-daily (morning and evening) and Fluticasone Furoate matching placebo once daily in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period |
|
| Arm 4 FP 100 mcg | Experimental | Subjects will receive Fluticasone Propionate 100 mcg twice-daily (morning and evening) and Fluticasone Furoate matching placebo once daily in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Furoate/Vilanterol | Drug | FF/VI 100mg/25 mcg is available as a dry white powder to be given once daily in the evening via dry powder inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants (Par) Withdrawn From the Study Due to "Poorly-controlled Asthma" During Period 2 | Asthma symptom scores (SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity [morning] or to 4-symptoms so severe that par could not sleep at all [nightly]. Withdrawal due to poorly-controlled(WPC) (required step-up therapy) asthma was defined as asthma worsening/exacerbation or ≧3 per week of : day symptoms on ≧ 2 days, rescue use on ≧2 days, morning PEF <80 % of best effort on ≧ 1 day, night symptoms on ≧1 or more day, a best pre-bronchodilator forced expiratory volume in 1s (FEV1) < 80% at clinic . Percentage of par WPC asthma at visit 6, 7, 9 and 11 (Week 10, 12, 16 and 20 respectively) were reported. Cox Proportional Hazards Model was used with covariates of Baseline FEV1, gender, age and treatment group. Analysis was descriptive only, no p -values calculated, treatment differences and associated 95% CI were produced. | From Week 9 to Week 20 |
| Percentage of Participants With 'Well-controlled Asthma' at the End of Period 2 | Asthma symptom scores(SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity[morning] or to 4-symptoms so severe that par could not sleep at all[nightly]. "Well-controlled asthma" was defined as having no exacerbation/asthma worsening, no night-time symptoms, a best pre-bronchodilator forced expiratory volume in 1 second ≥80% at clinic, and ≥2 per week of: daytime symptoms on ≤1 day, rescue use on ≤1 day, or morning peak expiratory flow ≥80% of the best effort value. "Well-controlled asthma" at the end of period 2 was assessed in the week prior to Visit 11 (Week 20). Percentage of participants were calculated as the number of participants with "well-controlled asthma" divided by total number participants excluding withdrawals prior to visit 11 (end of period 2) other than asthma worsening/exacerbation. A Logistic Regression Model was used with covariates of Baseline FEV1, gender, age and treatment group. | Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Change From Baseline in Clinic Visit Trough FEV1 at the End of Period 2 | FEV measures amount of air a person can exhale during a forced breath. The amount of air exhaled in one second of the forced breath is FEV1. Trough FEV1 was measured between 3pm and 11pm excluding Visit 1. Highest value from the three acceptable measurements were recorded. Change from Baseline was calculated as adjusted mean FEV1 value during Period 2 minus Baseline. The Baseline value was the predose value at the randomization (Visit 5: Week 8). Analysis of covariance (ANCOVA) Model was used with covariates of baseline FEV1, gender, age and treatment group. The adjusted mean from this model is presented [least square mean (LSM)]. |
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Inclusion Criteria:
Other inclusion criteria at Visit 2 and Visit 5:
Exclusion Criteria:
Note: Immunotherapy for the treatment of allergies is allowed during the study provided it was initiated at least 4 weeks prior to Visit 1 and subjects remain in the maintenance phase for the duration of the study; Cytochrome P450 3A4 (CYP3A4) inhibitors: Subjects who have received a potent CYP3A4 inhibitor within 4 weeks of Visit 1 (e.g.,Clarithromycin, atazanavir, indinavir, itraconazole, ketoconazole, nefazadone, nelfinavir; ritonavir; saquinavir; telithromycin, troleandomycin, voriconazole, mibefradil, cyclosporine, etc).
Other exclusion criteria at Visit 2 and Visit 5:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aomori | 036-8545 | Japan | |||
| GSK Investigational Site |
Not provided
| 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 |
|---|---|---|---|
| 201135 | Informed Consent Form | 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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Eligible participants entered a 4 week run-in period followed by an 8 week open label treatment period. Participants whose asthma was well controlled at visit 5 (end of Period 1) were randomized in a 1:1:1 ratio to a double blind study period of 12 weeks. They were informed to avoid Salbutamol inhaler within 6 hours at each visit.
A total of 551 participants were screened, 490 entered into the run-in period, 430 entered into the open label treatment period 1(Period 1) and 371 were further randomized to treatment Period 2 (Period 2). Note that 1 subject was randomized incorrectly even though the subject failed at randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | FF/VI 100/25 mcg OD | Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study. |
| FG001 | FF 100 mcg OD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 8 Weeks in Period 1 |
|
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| Fluticasone Furoate 100 mcg | Drug | FF 100 mcg is available as a dry white powder to be given once daily in the evening via dry powder inhaler |
|
| Fluticasone Propionate 250 mcg | Drug | FP 250 mcg is available as a dry white powder to be given twice daily (morning and evening) via dry powder inhaler |
|
| Fluticasone Propionate 100 mcg | Drug | FP 100 mcg is available as a dry white powder to be given twice daily (morning and evening) via dry powder inhaler |
|
| Fluticasone Furoate Placebo | Drug | Matching placebo of Fluticasone Furoate will be given once daily in the evening via dry powder inhaler |
|
| Fluticasone Propionate Placebo | Drug | Matching placebo of Fluticasone Propionate will be given twice daily (morning and evening) via dry powder inhaler |
|
| Week 20 |
| Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2 | Peak expiratory flow is a person's maximum speed of expiration, as measured with a peak flow meter which determines person's ability to breathe out air. PEF was measured each morning and evening prior to study medication or any rescue salbutamol inhalation aerosol use, using an electronic peak flow meter. Mean change from Baseline was calculated as PEF value averaged during Period 2 (Week 9 to Week 20) minus Baseline. Data is presented separately for morning(AM) and evening(PM) assessments. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8) separately for morning and evening. Adjusted mean change from baseline is presented [least square mean (LSM)]. | From Week 9 to Week 20 |
| Least Squares Mean Change From Baseline in the Percentage of Symptom Free 24 Hour Periods During Period 2 | Participants who were symptom free for 24-hours were assessed with the help of a daily Dairy. It included the details on daily asthma symptom scores ranging from 0 (no symptoms) to 5-symptoms so severe that participant could not perform normal activity [morning] or to 4-symptoms so severe that participants could not sleep at all [nightly]. Mean change from Baseline was calculated as percentage of symptom free 24 hours during Period 2 (Week 9 to Week 20) minus Baseline. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)]. | From Week 9 to Week 20 |
| Least Squares Mean Change From Baseline in the Percentage of Rescue Free 24 Hour (hr) Periods During Period 2 | The time during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Participants who did not require inhalation of salbutamol (rescue medication) for 24-hours were captured with the help of a daily dairy, all participants were required to record use of rescue medication daily for day and night time separately on e-diary. Mean change from Baseline was calculated as percentage of rescue free 24 hour period during Period 2 (Week 9 to Week 20) minus Baseline value. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)]. | From Week 9 to Week 20 |
| Least Squares Mean Change From Baseline in Asthma Control Test (ACT) Score at the End of Period 2 | The total ACT score is the sum of the scores attributed to the five questions, ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >=20 indicates well-controlled asthma. The questions were designed to be self-completed by the participant. Mean change from Baseline was calculated as ACT score at the end of Period 2 (Week 20) minus Baseline value. The Baseline value was the predose value at randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean(LSM)]. | Week 20 |
| Proportion of Subjects With ACT Score >= 20 at Visit 11 (Week 20) | Asthma control test is a five item questionnaire with each response rating from 1 to 5 (1 is severe and 5 is no event) of asthma events over previous 4-weeks. The questions were designed to be self-completed by the participant. The percentage of participants with ACT score >=20 at the end of the Period 2 were analyzed using a logistic regression model including covariates for baseline ACT score, gender, age and treatment group. | Week 20 |
| Fukuoka |
| 802-0052 |
| Japan |
| GSK Investigational Site | Fukuoka | 811-1394 | Japan |
| GSK Investigational Site | Fukuoka | 816-0813 | Japan |
| GSK Investigational Site | Fukuoka | 832-0059 | Japan |
| GSK Investigational Site | Gifu | 509-6134 | Japan |
| GSK Investigational Site | Hiroshima | 732-0052 | Japan |
| GSK Investigational Site | Hyōgo | 672-8064 | Japan |
| GSK Investigational Site | Ibaraki | 302-0022 | Japan |
| GSK Investigational Site | Ibaraki | 319-1113 | Japan |
| GSK Investigational Site | Kagawa | 760-0018 | Japan |
| GSK Investigational Site | Kagawa | 760-8538 | Japan |
| GSK Investigational Site | Kagawa | 761-8073 | Japan |
| GSK Investigational Site | Kagawa | 762-0031 | Japan |
| GSK Investigational Site | Kanagawa | 239-0821 | Japan |
| GSK Investigational Site | Kanagawa | 252-0143 | Japan |
| GSK Investigational Site | Kochi | 780-0901 | Japan |
| GSK Investigational Site | Kyoto | 612-0026 | Japan |
| GSK Investigational Site | Mie | 514-1101 | Japan |
| GSK Investigational Site | Mie | 515-8544 | Japan |
| GSK Investigational Site | Osaka | 560-0005 | Japan |
| GSK Investigational Site | Ōita | 870-0921 | Japan |
| GSK Investigational Site | Saitama | 343-0808 | Japan |
| GSK Investigational Site | Tokyo | 103-0027 | Japan |
| GSK Investigational Site | Tokyo | 104-8560 | Japan |
| GSK Investigational Site | Tokyo | 140-0011 | Japan |
| GSK Investigational Site | Tokyo | 140-0013 | Japan |
| GSK Investigational Site | Tokyo | 145-0063 | Japan |
| GSK Investigational Site | Tokyo | 171-0014 | Japan |
| GSK Investigational Site | Tokyo | 187-0002 | Japan |
| GSK Investigational Site | Tokyo | 190-0014 | Japan |
| GSK Investigational Site | Tokyo | 191-0031 | Japan |
| GSK Investigational Site | Tokyo | 204-8522 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 201135 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201135 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201135 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201135 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
| FG002 | FP 100 mcg BD | Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
| FG003 | FP 250 mcg BD | Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
| COMPLETED |
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| NOT COMPLETED |
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|
| 12 Weeks in Period 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Period 1- FF/VI 100/25 mcg OD | Participants received FF/VI 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study. |
| 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 | Percentage of Participants (Par) Withdrawn From the Study Due to "Poorly-controlled Asthma" During Period 2 | Asthma symptom scores (SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity [morning] or to 4-symptoms so severe that par could not sleep at all [nightly]. Withdrawal due to poorly-controlled(WPC) (required step-up therapy) asthma was defined as asthma worsening/exacerbation or ≧3 per week of : day symptoms on ≧ 2 days, rescue use on ≧2 days, morning PEF <80 % of best effort on ≧ 1 day, night symptoms on ≧1 or more day, a best pre-bronchodilator forced expiratory volume in 1s (FEV1) < 80% at clinic . Percentage of par WPC asthma at visit 6, 7, 9 and 11 (Week 10, 12, 16 and 20 respectively) were reported. Cox Proportional Hazards Model was used with covariates of Baseline FEV1, gender, age and treatment group. Analysis was descriptive only, no p -values calculated, treatment differences and associated 95% CI were produced. | Intent-to-treat (ITT) population defined as participants randomized to treatment and who received at least one dose of randomized study medication in Period 2. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Week 9 to Week 20 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With 'Well-controlled Asthma' at the End of Period 2 | Asthma symptom scores(SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity[morning] or to 4-symptoms so severe that par could not sleep at all[nightly]. "Well-controlled asthma" was defined as having no exacerbation/asthma worsening, no night-time symptoms, a best pre-bronchodilator forced expiratory volume in 1 second ≥80% at clinic, and ≥2 per week of: daytime symptoms on ≤1 day, rescue use on ≤1 day, or morning peak expiratory flow ≥80% of the best effort value. "Well-controlled asthma" at the end of period 2 was assessed in the week prior to Visit 11 (Week 20). Percentage of participants were calculated as the number of participants with "well-controlled asthma" divided by total number participants excluding withdrawals prior to visit 11 (end of period 2) other than asthma worsening/exacerbation. A Logistic Regression Model was used with covariates of Baseline FEV1, gender, age and treatment group. | ITT population. Participants who withdrew prior to Visit 11 for the reasons other than exacerbation were excluded. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 20 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in Clinic Visit Trough FEV1 at the End of Period 2 | FEV measures amount of air a person can exhale during a forced breath. The amount of air exhaled in one second of the forced breath is FEV1. Trough FEV1 was measured between 3pm and 11pm excluding Visit 1. Highest value from the three acceptable measurements were recorded. Change from Baseline was calculated as adjusted mean FEV1 value during Period 2 minus Baseline. The Baseline value was the predose value at the randomization (Visit 5: Week 8). Analysis of covariance (ANCOVA) Model was used with covariates of baseline FEV1, gender, age and treatment group. The adjusted mean from this model is presented [least square mean (LSM)]. | ITT population. Number of participants available for the last post-baseline value during Period 2 were used for analysis. | Posted | Least Squares Mean | Standard Error | Liter | Week 20 |
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| Secondary | Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2 | Peak expiratory flow is a person's maximum speed of expiration, as measured with a peak flow meter which determines person's ability to breathe out air. PEF was measured each morning and evening prior to study medication or any rescue salbutamol inhalation aerosol use, using an electronic peak flow meter. Mean change from Baseline was calculated as PEF value averaged during Period 2 (Week 9 to Week 20) minus Baseline. Data is presented separately for morning(AM) and evening(PM) assessments. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8) separately for morning and evening. Adjusted mean change from baseline is presented [least square mean (LSM)]. | ITT population. Only those participants available at specified timepoints were analyzed | Posted | Least Squares Mean | Standard Error | Liter per minute (L/min) | From Week 9 to Week 20 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in the Percentage of Symptom Free 24 Hour Periods During Period 2 | Participants who were symptom free for 24-hours were assessed with the help of a daily Dairy. It included the details on daily asthma symptom scores ranging from 0 (no symptoms) to 5-symptoms so severe that participant could not perform normal activity [morning] or to 4-symptoms so severe that participants could not sleep at all [nightly]. Mean change from Baseline was calculated as percentage of symptom free 24 hours during Period 2 (Week 9 to Week 20) minus Baseline. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)]. | ITT population. Only those participants available at specified time point were analyzed | Posted | Least Squares Mean | Standard Error | Percentage of symptom-free 24-h period | From Week 9 to Week 20 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in the Percentage of Rescue Free 24 Hour (hr) Periods During Period 2 | The time during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Participants who did not require inhalation of salbutamol (rescue medication) for 24-hours were captured with the help of a daily dairy, all participants were required to record use of rescue medication daily for day and night time separately on e-diary. Mean change from Baseline was calculated as percentage of rescue free 24 hour period during Period 2 (Week 9 to Week 20) minus Baseline value. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)]. | ITT population. Only those participants available at specified time point were analyzed | Posted | Least Squares Mean | Standard Error | Percentage of rescue-free 24-hr periods | From Week 9 to Week 20 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in Asthma Control Test (ACT) Score at the End of Period 2 | The total ACT score is the sum of the scores attributed to the five questions, ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >=20 indicates well-controlled asthma. The questions were designed to be self-completed by the participant. Mean change from Baseline was calculated as ACT score at the end of Period 2 (Week 20) minus Baseline value. The Baseline value was the predose value at randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean(LSM)]. | ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated. | Posted | Least Squares Mean | Standard Error | Score on scale | Week 20 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With ACT Score >= 20 at Visit 11 (Week 20) | Asthma control test is a five item questionnaire with each response rating from 1 to 5 (1 is severe and 5 is no event) of asthma events over previous 4-weeks. The questions were designed to be self-completed by the participant. The percentage of participants with ACT score >=20 at the end of the Period 2 were analyzed using a logistic regression model including covariates for baseline ACT score, gender, age and treatment group. | ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 20 |
|
Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FF/VI 100/25 mcg OD Period 1 | Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study. | 0 | 430 | 67 | 430 | ||
| EG001 | FF 100 mcg OD Period 2 | Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. | 1 | 123 | 22 | 123 | ||
| EG002 | FP 100 mcg BD Period 2 | Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. | 0 | 124 | 22 | 124 | ||
| EG003 | FP 250 mcg BD Period 2 | Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. | 1 | 124 | 28 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Abortion complete | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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 |
|---|---|
| C523187 | fluticasone furoate |
| C550468 | vilanterol |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Lack of Efficacy |
|
| Protocol defined stopping criteria |
|
| Withdrawal by Subject |
|
| Randomized incorrectly |
|
| Hazard Ratio (HR) |
| 0.79 |
| 2-Sided |
| 95 |
| 0.28 |
| 2.19 |
| Superiority or Other |
| FP 100 mcg BD |
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
| OG002 | FP 250 mcg BD | Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
|
|
|
| OG002 | FP 250 mcg BD | Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
|
|
| OG002 | FP 250 mcg BD | Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
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| OG002 | FP 250 mcg BD | Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
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| OG002 | FP 250 mcg BD | Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
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| OG002 | FP 250 mcg BD | Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
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| FP 250 mcg BD |
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study. |
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