Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02184611 | A 24 Week Efficacy Study of Inhaled Umeclidinium (UMEC) in Patients of Chronic Obstructive Pulmonary Disease (COPD) Using a Novel Dry Powder Inhaler (NDPI) | PHASE3 | COMPLETED | 308 | — | — | May 9, 2016 | Nov 8, 2017 | Jun 29, 2020 | 26 | China, South Korea |
| NCT01822899 | A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 717 | — | — | Apr 4, 2013 | Oct 7, 2013 | Sep 6, 2017 | 78 | Czechia, Denmark +6 |
| NCT01772134 | Efficacy and Safety of the Addition of Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide (62.5 or 125mcg) Once-daily Over 12 Weeks | PHASE3 | COMPLETED | 617 | — | — | Jan 1, 2013 | Jul 22, 2013 | Jan 29, 2018 | 73 | United States, Canada +2 |
| NCT01772147 | Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks. | PHASE3 | COMPLETED | 608 | — | — | Jan 1, 2013 | Aug 1, 2013 | Mar 23, 2017 | 55 | United States, Chile +3 |
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 169 was defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 168 (i.e. at Week 24). Baseline FEV1 is defined as the mean of the two assessments made pre-dose at Visit 2 (Day 1). Change from Baseline was calculated by subtracting the value on-treatment from the Baseline value. Modified intent-to-treat (mITT) Population comprised of all participants randomized to treatment who received at least one dose of the study medication in the 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 weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status.
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 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.
| Arm | Type | Description |
|---|---|---|
| Umeclidinium bromide | EXPERIMENTAL | Subjects meeting the eligibility criteria will complete a 7 to 14 day run-in period and will be randomized to receive UMEC Inhalation Powder 62.5 mcg OD over a period of 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Subjects meeting the eligibility criteria will complete a 7 to 14 day run-in period and will be randomized to receive matching placebo of UMEC Inhalation Powder OD over a period of 24 weeks |
| Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | EXPERIMENTAL | Subjects will receive UMEC/ VI 62.5/25 mcg, one inhalation administered once-daily in the morning via the NDPI and one placebo ACCUHALER/DISKUS administered as one inhalation each morning and evening. |
| Fluticasone propionate/Salmeterol + placebo NDPI | ACTIVE_COMPARATOR | Subjects will receive FSC 500/50 mcg, administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once daily in the morning via NDPI. |
| Umeclidinium bromide 62.5 + Fluticasone propionate/Salmeterol | EXPERIMENTAL | Long-acting muscarinic antagonist (LAMA), 62.5mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg |
| Umeclidinium bromide 125 + Fluticasone propionate/Salmeterol | ACTIVE_COMPARATOR | Long-acting muscarinic antagonist (LAMA), 125mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg |
| Placebo + Fluticasone propionate/Salmeterol | PLACEBO_COMPARATOR | Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg |
| Fluticasone propionate/Salmeterol | ACTIVE_COMPARATOR | Inhaled corticosteroid (ICS)/Long-acting beta agonist (LABA) |
| Name | Type | Description |
|---|---|---|
| Umeclidinium bromide | DRUG | Blended with lactose and magnesium stearate dry white powder of umeclidinium 62.5 mcg to be inhaled via a NDPI |
| Placebo | DRUG | Blended with lactose and magnesium stearate dry white powder to be inhaled via a NDPI |
| Umeclidinium bromide/Vilanterol | DRUG | Dry white powder of UMEC 62.5 mcg per blister and VI 25 mcg per blister as NDPI with 30 doses (2 strips with 30 blisters per strip). |
| Placebo ACCUHALER/DISKUS | DRUG | Dry white powder of matching placebo as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip). |
| Fluticasone propionate/Salmeterol | DRUG | Dry white powder of fluticasone propionate 500 mcg per blister 50 mcg salmeterol per blister as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip). |
| Placebo NDPI | DRUG | Dry white powder of matching placebo as NDPI with 30 doses (2 strips with 30 blisters per strip). |
| Umeclidinium bromide 62.5mcg | DRUG | Inhalation Powder, LAMA 62.5mcg |
| Umeclidinium bromide 125mcg | DRUG | Inhalation Powder, LAMA 125mcg |
| Fluticasone propionate 250mcg/Salmeterol 50mcg | DRUG | Inhalation Powder, ICS/LABA |
Inclusion Criteria: * Type of subject: outpatient, Asian ancestry. * Informed Consent: A signed and dated written informed consent prior to study participation. * Age: 40 years of age or older at Screening (Visit 1). * Gender: Male or female subjects are eligible to participate in the study. A fema...