| Title |
A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 µg compared with tiotropium 18 µg in patients with COPD
|
|---|---|
| Published in |
International Journal of Chronic Obstructive Pulmonary Disease, April 2016
|
| DOI | 10.2147/copd.s102494 |
| Pubmed ID | |
| Authors |
Gregory Feldman, François Maltais, Sanjeev Khindri, Mitra Vahdati-Bolouri, Alison Church, William A Fahy, Roopa Trivedi |
| Abstract |
The long-acting muscarinic antagonists umeclidinium (UMEC) and tiotropium (TIO) are approved once-daily maintenance therapies for COPD. This study investigated the efficacy and safety of UMEC versus TIO in COPD. This was a 12-week, multicenter, randomized, blinded, double-dummy, parallel-group, non-inferiority study. Patients were randomized 1:1 to UMEC 62.5 μg plus placebo or TIO 18 μg plus placebo. The primary end point was trough forced expiratory volume in 1 second (FEV1) at day 85 (non-inferiority margin -50 mL; per-protocol [PP] population). Other end points included weighted mean FEV1 over 0-24 and 12-24 hours post-dose. Patient-reported outcomes comprised Transition Dyspnea Index score, St George's Respiratory Questionnaire total score, and COPD Assessment Test score. Adverse events were also assessed. In total, 1,017 patients were randomized to treatment. In the PP population, 489 and 487 patients received UMEC and TIO, respectively. In the PP population, change from baseline in trough FEV1 was greater with UMEC versus TIO at day 85, meeting non-inferiority and superiority margins (difference: 59 mL; 95% confidence interval [CI]: 29-88; P<0.001). Similar results were observed in the intent-to-treat analysis of trough FEV1 at day 85 (53 mL, 95% CI: 25-81; P<0.001). Improvements in weighted mean FEV1 over 0-24 hours post-dose at day 84 were similar with UMEC and TIO but significantly greater with UMEC versus TIO over 12-24 hours post-dose (70 mL; P=0.015). Clinically meaningful improvements in Transition Dyspnea Index and St George's Respiratory Questionnaire were observed with both treatments at all time points. No differences were observed between UMEC and TIO in patient-reported outcomes. Overall incidences of adverse events were similar for UMEC and TIO. UMEC 62.5 μg demonstrated superior efficacy to TIO 18 μg on the primary end point of trough FEV1 at day 85. Safety profiles were similar for both treatments. |
X Demographics
The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Japan | 1 | 33% |
| Unknown | 2 | 67% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 67% |
| Practitioners (doctors, other healthcare professionals) | 1 | 33% |
Mendeley readers
The data shown below were compiled from readership statistics for 82 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 1 | 1% |
| Spain | 1 | 1% |
| Unknown | 80 | 98% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Other | 20 | 24% |
| Student > Master | 11 | 13% |
| Student > Bachelor | 8 | 10% |
| Researcher | 7 | 9% |
| Student > Postgraduate | 6 | 7% |
| Other | 13 | 16% |
| Unknown | 17 | 21% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 27 | 33% |
| Pharmacology, Toxicology and Pharmaceutical Science | 15 | 18% |
| Agricultural and Biological Sciences | 6 | 7% |
| Nursing and Health Professions | 6 | 7% |
| Biochemistry, Genetics and Molecular Biology | 3 | 4% |
| Other | 7 | 9% |
| Unknown | 18 | 22% |
Attention Score in Context
This research output has an Altmetric Attention Score of 15. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 30 January 2020.
All research outputs
#2,329,989
of 25,374,647 outputs
Outputs from International Journal of Chronic Obstructive Pulmonary Disease
#215
of 2,577 outputs
Outputs of similar age
#37,355
of 314,725 outputs
Outputs of similar age from International Journal of Chronic Obstructive Pulmonary Disease
#7
of 68 outputs
Altmetric has tracked 25,374,647 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 90th percentile: it's in the top 10% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 2,577 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.5. This one has done particularly well, scoring higher than 91% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 314,725 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 88% of its contemporaries.
We're also able to compare this research output to 68 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 89% of its contemporaries.