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This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are currently using non-ICS controller medications. Subjects will participate in the study for up to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment sequence.
A sub-group of subjects at selected sites (approximately 30% of the total population) will have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic sampling at the start and end of each treatment period. Safety assessments will include monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic analysis.
Asthma, a reversible obstructive disease of the airways, is defined as a chronic inflammatory disorder of the airways in which many of the cells and cellular mediators play a role. The chronic inflammation is associated with airway hyper-responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or early in the morning. These episodes are usually associated with widespread, but variable airflow obstruction within the lung that is often reversible either spontaneously or with treatment (NIH 2007, GINA, 2010,). Guidelines recommend a stepwise approach to the management of asthma. For many patients with mild disease, asthma symptoms can be adequately relieved by 'on demand' use of a short acting beta-2 -agonist (SABA) alone. A long-acting, inhaled, muscarinic receptor antagonist (LAMA) exerts its effects via distinct and complementary bronchodilator mechanisms on large and small airways through antagonism of the endogenous agonist acetylcholine at the muscarinic receptors leading to smooth muscle relaxation and bronchodilation. However, most experience with older anti-cholinergics has been with acute use and little is known about their effect in chronic use or as maintenance in asthma.
Newer more selective muscarinic receptor antagonists are being developed for chronic use which appear to have a better adverse event profile compared with older anti-cholinergics in the treatment of asthma [Moulton 2011]. A once daily long-acting, inhaled, muscarinic receptor antagonist (LAMA) bronchodilator, GSK573719, may offer an alternative treatment option to patients with asthma.
The proposed study is a multi-national, randomized, double-blind, 3-period crossover, incomplete block study in outpatient subjects with mild asthma and who are not using inhaled corticosteroids (ICS) for symptom control. The primary objective of this study is to evaluate the dose response, efficacy and safety of five once-daily doses of GSK573719 compared with placebo, over a 14-day treatment period, in patients with asthma. A placebo arm will be included to determine an absolute treatment effect over placebo for each GSK573719 dose regimen.
Each eligible subject will be randomized to receive 3 out of 8 potential treatments in sequence over a total of three 14-day treatment periods. There will be 12 clinic visits including a safety follow-up visit at the end of the study. All subjects will be provided with albuterol (salbutamol) for use on an 'as-needed' basis throughout the run-in, treatment and washout periods. A sub-group (approximately 30%) of the study population will comprise subjects from selected sites. These subjects will have additional assessments at the start and end of each treatment period, including serial spirometry, serial ECGs, 24 hour Holter monitoring, and samples of blood and urine for pharmacokinetic analysis. Other safety parameters include the incidence of adverse events, vital signs, clinical laboratory parameters, ECGs and spirometry, including twice daily peak expiratory flow, asthma exacerbation assessment. and use of salbutamol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK573719 15.6 mcg | Experimental | GSK573719 (Umeclinidium bromide) 15.6 mcg once-daily |
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| GSK573719 31.25 mcg | Experimental | GSK573719 (Umeclinidium bromide) 31.25 mcg once-daily |
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| GSK573719 62.5 mcg | Experimental | GSK573719 (Umeclinidium bromide) 62.5 mcg once-daily |
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| GSK573719 125 mcg | Experimental | GSK573719 (Umeclinidium bromide) 125 mcg once-daily |
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| GSK573719 250 mcg | Experimental | GSK573719 (Umeclinidium bromide) 250 mcg once-daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK573719 Active treatment or Placebo | Drug | Eligible subjects will be randomised to a sequence of three treatments from 8 possible arms: 7 active drug doses (15.6mcg, 31.25 mc, 62.5mcg 125mcg or 250mcg GSK573719 once daily; 15.6mcg or 31.25 mcg GSK573719 taken twice daily) or matched placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) | Dose-response was conducted for both QD and BID UMEC doses on trough FEV1 (measure of lung function, defined as the maximal amount of air that can be forcefully exhaled in 1 second) on D 15. Total daily dose of UMEC was used in the modeling. The null model was the final model. The null model is defined as: CFEV1,ij=(THETA1+ETA1j)*meanBL+(THETA2+ETA1j)*periodBL+EPSij, where CFEV1,ij represents the change from BL in trough FEV1 for participant j measured at period i. THETA1 and THETA2 were the slopes with respect to meanBL and periodBL, respectively. Omegas were the variance of the slopes on meanBL and periodBL (ETA1j, ETA2j) for each participant and Sigma was the variance of the residual errors (EPSij). MeanBL is the mean of the Baseline (BL) which is the FEV1 value recorded pre-dose on D 1 of each TP; periodBL is the difference between the BL and the meanBL in each TP for each participant. | Day 15 of each treatment period (up to Study Day 71) |
| Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1 and mean Baseline FEV1 as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period. | Day 15 of each treatment period (up to Study Day 71) |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of SAEs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (BL) in the Weighted Mean (WM) 0-24 Hour FEV1 Obtained Post-AM Dose on Day 14 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from BL at a was calculated as WM at the evaluated time point minus BL. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1, and mean Baseline FEV1 as fixed effects and participant as a random effect. |
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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 | Newport Beach | California | 92663 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25464907 | Derived | Lee LA, Briggs A, Edwards LD, Yang S, Pascoe S. A randomized, three-period crossover study of umeclidinium as monotherapy in adult patients with asthma. Respir Med. 2015 Jan;109(1):63-73. doi: 10.1016/j.rmed.2014.10.009. Epub 2014 Oct 28. |
| 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 |
|---|---|---|---|
| 116402 | 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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Participants were randomized to receive a sequence of 3 of 8 possible treatments over 3 treatment periods. There are 56 combinations of 3 treatments from the 8 study treatments, each of which can be ordered in 6 ways (totaling 336 possible sequences; 246 were randomly assigned). Participant Flow data are presented by treatment rather than sequence.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days. |
| FG001 | UMEC 15.6 µg QD | Participants received umeclidinium bromide (UMEC) 15.6 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| GSK573719 15.6 mcg twice-daily | Experimental | GSK573719 (Umeclinidium bromide) 15.6 mcg twice-daily |
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| GSK573719 31.25 mcg twice daily | Experimental | Gsk573719 (Umeclinidium bromide) 31.25 mcg twice-daily |
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| Matched Placebo | Placebo Comparator | Matched Placebo arm |
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| GSK573719 (Sub-group cohort) | Procedure | Subjects at selected Sub-group sites (approximately 30% of the total population) will have additional serial assessments and procedures (including blood and urine samples for pharmacokinetic analysis) at the start (Day 1) and at the end (Days 14 and 15) of each treatment period. On Day 14 of each treatment period subjects will remain overnight at the clinic for 24-hour assessments, including spirometry, ECGs, and 24-hour Holter monitoring. |
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| Salbutamol/Albuterol | Drug | Salbutamol/Albuterol, short-activing beta agonist provided to all subjects to be taken as needed for the relief of asthma symptoms.throughout the study period, including washout periods |
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| From Baseline until the end of Treatment Period 3 (up to Study Day 70) |
| Number of Participants With Asthma Exacerbations During the Treatment Period | Worsening of asthma symptoms is monitored throughout the study. Severe exacerbation (deterioration of asthma requiring use of systemic corticosteroids for 3 days, inpatient hospitalization or emergency department visit due to asthma) is an exclusion criterion and requires withdrawal from the study. Asthma symptoms were assessed daily using an electronic diary throughout study. | From Baseline until the end of Treatment Period 3 (up to Study Day 70) |
| Change From Baseline in Systolic Blood Pressure on Day 14 of Each Treatment Period | Blood pressure measurement included systolic blood pressure (SBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in Diastolic Blood Pressure on Day 14 of Each Treatment Period | Blood pressure measurement included diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in Pulse Rate on Day 14 of Each Treatment Period | Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in Albumin, Total Protein, and Hemoglobin on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70)) |
| Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of ALP, ALT, AST, CK, GGT, and LDH at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of direct bilirubin, indirect (ind) bilirubin, total bilirubin, and creatinine at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of chloride, caron dioxide, glucose, potassium, sodium, and urea/BUN at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC - Absolute Neutrophil Count), Platelet, and Leukocytes Count on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - Absolute neutrophil [neut] count), platelet, and leucocytes count at Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils (neut) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in Hematocrit on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick on Day 14 of Each Treatment Period | Urinalysis parameters included: Urine Bilirubin (UB), Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Nitrite (UN), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace (T), 1+, 2+, and 3+, and for UG the result can be read as Neg, T, T or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, T, 1+, 2+ and 3+ levels at Day 14. | Baseline and Day 14 of each treatment period (up to Study Day 70)) |
| Urine pH on Day 14 of Each Treatment Period | Urine samples were collected for the measurement of urine pH by dipstick method at Day 14. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Day 14 of each treatment period (up to Study Day 70) |
| Urine Specific Gravity on Day 14 of Each Treatment Period | Urine samples were collected for the measurement of urine specific gravity by dipstick method at Day 14. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. | Day 14 of each treatment period (up to Study Day 70) |
| Number of Participants With the Indicated Abnormal Electrocardiogram Findings | Electrocardiograph measurements performed at Screening (Visit 1) and at Day 1 and Day 14 (pre-dose, 10 minutes post-dose and 2 hours post-dose.of each treatment period). Any clinically significant findings were identified during participant monitoring. | Day 14 of each treatment period (up to Study Day 70) |
| Number of Participants With the Indicated 24 Hour Holter Findings | Twenty-four hour Holter ECG measurements were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart's rhythm while the monitor is worn. Following the 24-hour period, the data from the monitor were downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist. The 24-hour Holter ECG measurements were obtained at during the screening period and on Day 14 of each treatment period. The number of participants with clinically significant change (abnormal or normal) were reported. | Day 14 of each treatment period (up to Study Day 70) |
| Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change in Baseline in Serial FEV1 Over 0-24 Hours After the Morning Dose on Day 14 of Each Treatment Period | Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 was measured at 5, 15, 30 minutes (min), 1, 3, 6, 9, 12, 16, 20, 23 and 24 hours (h) post-dose. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis was preformed using a repeated measures model with terms for period, treatment, time, mean Baseline, period Baseline, and time by mean Baseline, time by period Baseline, and time by treatment interactions. | Baseline and Day 14 of each treatment period (up to Study Day 70) |
| Change From Baseline in Mean Morning (AM) and Evening (PM) Pre-treatment Peak Expiratory Flow (PEF) Over Day 7 to Day 14 of Each Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 7 to 14 was analyzed. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; Baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect. | Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70) |
| Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Day 7 to Day 14 of Each Treatment Period | The mean number of puffs per day of rescue salbutamol at Baseline (i.e. run-in or washout data) and on-treatment were recorded. Total puffs was calculated as (Number of Puffs + (2 x number of Nebules)). Only the 7 days proceeding each treatment period were included in the Baseline calculations. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70) |
| Sunset |
| Louisiana |
| 70584 |
| United States |
| GSK Investigational Site | Bethesda | Maryland | 20814 | United States |
| GSK Investigational Site | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | Rolla | Missouri | 65401 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Bellevue | Nebraska | 68123-4303 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Austin | Texas | 78750 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Lovech | 5500 | Bulgaria |
| GSK Investigational Site | Pleven | 5800 | Bulgaria |
| GSK Investigational Site | Plovdiv | 4003 | Bulgaria |
| GSK Investigational Site | Rousse | 7000 | Bulgaria |
| GSK Investigational Site | Sofia | 1431 | Bulgaria |
| GSK Investigational Site | Stara Zagora | 6000 | Bulgaria |
| GSK Investigational Site | Varna | 9000 | Bulgaria |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22299 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22767 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Neu-Isenburg | Hesse | 63263 | Germany |
| GSK Investigational Site | Geesthacht | Schleswig-Holstein | 21502 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10717 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10789 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12203 | Germany |
| GSK Investigational Site | Guadalajara | Jalisco | 44100 | Mexico |
| GSK Investigational Site | Zapopan | Jalisco | 45040 | Mexico |
| GSK Investigational Site | Lima | Lima Province | Lima 18 | Peru |
| GSK Investigational Site | Lima | Lima Province | Lima 1 | Peru |
| GSK Investigational Site | Lima | Lima Province | Lima 27 | Peru |
| GSK Investigational Site | San Borja | Lima region | Lima 41 | Peru |
| GSK Investigational Site | San Miguel | Lima region | Lima 32 | Peru |
| GSK Investigational Site | Santiago de Surco | Lima region | Lima 33 | Peru |
| GSK Investigational Site | Bialystok | 15-010 | Poland |
| GSK Investigational Site | Krakow | 31-024 | Poland |
| GSK Investigational Site | Krakow | 31-455 | Poland |
| GSK Investigational Site | Ruda Śląska | 41-790 | Poland |
| GSK Investigational Site | Zawadzkie | 47-120 | Poland |
| GSK Investigational Site | Zgierz | 95-100 | Poland |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116402 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116402 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116402 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116402 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116402 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116402 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | UMEC 31.25 µg QD | Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| FG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| FG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| FG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| FG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| FG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
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| Washout Period 1 (12-14 Days) |
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| Treatment Period 2 |
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| Washout Period 2 (12-14 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Treatments | The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments : UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo. |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) | Dose-response was conducted for both QD and BID UMEC doses on trough FEV1 (measure of lung function, defined as the maximal amount of air that can be forcefully exhaled in 1 second) on D 15. Total daily dose of UMEC was used in the modeling. The null model was the final model. The null model is defined as: CFEV1,ij=(THETA1+ETA1j)*meanBL+(THETA2+ETA1j)*periodBL+EPSij, where CFEV1,ij represents the change from BL in trough FEV1 for participant j measured at period i. THETA1 and THETA2 were the slopes with respect to meanBL and periodBL, respectively. Omegas were the variance of the slopes on meanBL and periodBL (ETA1j, ETA2j) for each participant and Sigma was the variance of the residual errors (EPSij). MeanBL is the mean of the Baseline (BL) which is the FEV1 value recorded pre-dose on D 1 of each TP; periodBL is the difference between the BL and the meanBL in each TP for each participant. | Intent-To-Treat (ITT) Population: : all participants randomized to treatment and who received at least one dose of study medication. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15. | Posted | Geometric Mean | 95% Confidence Interval | unitless | Day 15 of each treatment period (up to Study Day 71) |
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| Primary | Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1 and mean Baseline FEV1 as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period. | ITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15. | Posted | Least Squares Mean | Standard Error | Liters | Day 15 of each treatment period (up to Study Day 71) |
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| Primary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of SAEs. | ITT Population | Posted | Number | Participants | From Baseline until the end of Treatment Period 3 (up to Study Day 70) |
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| Primary | Number of Participants With Asthma Exacerbations During the Treatment Period | Worsening of asthma symptoms is monitored throughout the study. Severe exacerbation (deterioration of asthma requiring use of systemic corticosteroids for 3 days, inpatient hospitalization or emergency department visit due to asthma) is an exclusion criterion and requires withdrawal from the study. Asthma symptoms were assessed daily using an electronic diary throughout study. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Participants | From Baseline until the end of Treatment Period 3 (up to Study Day 70) |
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| Primary | Change From Baseline in Systolic Blood Pressure on Day 14 of Each Treatment Period | Blood pressure measurement included systolic blood pressure (SBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Millimeters of mercury (mmHg) | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Change From Baseline in Diastolic Blood Pressure on Day 14 of Each Treatment Period | Blood pressure measurement included diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Millimeters of mercury (mmHg) | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Change From Baseline in Pulse Rate on Day 14 of Each Treatment Period | Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Beats per minute | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Change From Baseline in Albumin, Total Protein, and Hemoglobin on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Grams per liter (G/L) | Baseline and Day 14 of each treatment period (up to Study Day 70)) |
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| Primary | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of ALP, ALT, AST, CK, GGT, and LDH at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | International Units/Liter (IU/L) | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of direct bilirubin, indirect (ind) bilirubin, total bilirubin, and creatinine at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Micromoles/Liter (µM/L) | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of chloride, caron dioxide, glucose, potassium, sodium, and urea/BUN at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Micromoles/Liter (µM/L) | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC - Absolute Neutrophil Count), Platelet, and Leukocytes Count on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - Absolute neutrophil [neut] count), platelet, and leucocytes count at Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | 10^9 cells/Liter (GI/L) | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils (neut) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Percentage of cells in blood | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Change From Baseline in Hematocrit on Day 14 of Each Treatment Period | Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick on Day 14 of Each Treatment Period | Urinalysis parameters included: Urine Bilirubin (UB), Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Nitrite (UN), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace (T), 1+, 2+, and 3+, and for UG the result can be read as Neg, T, T or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, T, 1+, 2+ and 3+ levels at Day 14. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Number | Participants | Baseline and Day 14 of each treatment period (up to Study Day 70)) |
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| Primary | Urine pH on Day 14 of Each Treatment Period | Urine samples were collected for the measurement of urine pH by dipstick method at Day 14. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Urine Specific Gravity on Day 14 of Each Treatment Period | Urine samples were collected for the measurement of urine specific gravity by dipstick method at Day 14. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Number of Participants With the Indicated Abnormal Electrocardiogram Findings | Electrocardiograph measurements performed at Screening (Visit 1) and at Day 1 and Day 14 (pre-dose, 10 minutes post-dose and 2 hours post-dose.of each treatment period). Any clinically significant findings were identified during participant monitoring. | ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. | Posted | Number | Participants | Day 14 of each treatment period (up to Study Day 70) |
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| Primary | Number of Participants With the Indicated 24 Hour Holter Findings | Twenty-four hour Holter ECG measurements were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart's rhythm while the monitor is worn. Following the 24-hour period, the data from the monitor were downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist. The 24-hour Holter ECG measurements were obtained at during the screening period and on Day 14 of each treatment period. The number of participants with clinically significant change (abnormal or normal) were reported. | ITT Population. Only participants with sufficient data (at least 16 hours of recorded data) at the specified time points were analyzed. | Posted | Number | Participants | Day 14 of each treatment period (up to Study Day 70) |
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| Secondary | Change From Baseline (BL) in the Weighted Mean (WM) 0-24 Hour FEV1 Obtained Post-AM Dose on Day 14 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from BL at a was calculated as WM at the evaluated time point minus BL. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1, and mean Baseline FEV1 as fixed effects and participant as a random effect. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Liters | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Secondary | Change in Baseline in Serial FEV1 Over 0-24 Hours After the Morning Dose on Day 14 of Each Treatment Period | Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 was measured at 5, 15, 30 minutes (min), 1, 3, 6, 9, 12, 16, 20, 23 and 24 hours (h) post-dose. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis was preformed using a repeated measures model with terms for period, treatment, time, mean Baseline, period Baseline, and time by mean Baseline, time by period Baseline, and time by treatment interactions. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Least Squares Mean | Standard Error | Liters | Baseline and Day 14 of each treatment period (up to Study Day 70) |
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| Secondary | Change From Baseline in Mean Morning (AM) and Evening (PM) Pre-treatment Peak Expiratory Flow (PEF) Over Day 7 to Day 14 of Each Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 7 to 14 was analyzed. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; Baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect. | ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by "n=X, X" in the category title and the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Liters per minute | Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70) |
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| Secondary | Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Day 7 to Day 14 of Each Treatment Period | The mean number of puffs per day of rescue salbutamol at Baseline (i.e. run-in or washout data) and on-treatment were recorded. Total puffs was calculated as (Number of Puffs + (2 x number of Nebules)). Only the 7 days proceeding each treatment period were included in the Baseline calculations. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Number of puffs | Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70) |
|
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to Study Day 70).
On-treatment SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received at least one dose of randomized study medication during treatment period. Provision was made for the collection of any SAEs during the 9 - 14 days screening (pre-treatment) period. None was reported.
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 | Placebo | Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days. | 0 | 126 | 4 | 126 | ||
| EG001 | UMEC 15.6 µg QD | Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. | 0 | 131 | 7 | 131 | ||
| EG002 | UMEC 31.5 µg QD | Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. | 0 | 138 | 7 | 138 | ||
| EG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. | 0 | 133 | 12 | 133 | ||
| EG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. | 0 | 128 | 11 | 128 | ||
| EG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. | 1 | 135 | 12 | 135 | ||
| EG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. | 0 | 126 | 7 | 126 | ||
| EG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. | 0 | 133 | 7 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous abortion | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Product taste abnormal | General 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 |
|---|---|
| C573971 | GSK573719 |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Protocol Violation |
|
| Protocol-defined Stopping Criteria |
|
| Withdrawal by Subject |
|
| Protocol-defined Stopping Criteria |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Protocol-defined Stopping Criteria |
|
| Lost to Follow-up |
|
| Protocol-defined Stopping Criteria |
|
| Asian-Japanese/East Asian HER/South East Asian HER |
|
| White |
|
| American Indian or Alaskan Native & White |
|
|
| Omega (period Baseline) |
|
| Sigma (Variance of Residual error) |
|
| OG002 | UMEC 31.25 µg QD | Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
|
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| UMEC 62.5 µg QD |
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| UMEC 31.25 µg QD |
Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
|
| UMEC 31.25 µg QD |
Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
|
Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
|
| OG003 |
| UMEC 62.5 µg QD |
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG002 | UMEC 31.25 µg QD | Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| UMEC 62.5 µg QD |
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG003 |
| UMEC 62.5 µg QD |
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG002 | UMEC 31.25 µg QD | Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG002 | UMEC 31.25 µg QD | Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
|
|
| OG003 | UMEC 62.5 µg QD | Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG004 | UMEC 125 µg QD | Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG005 | UMEC 250 µg QD | Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. |
| OG006 | UMEC 15.6 µg BID | Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
| OG007 | UMEC 31.25 µg BID | Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. |
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|