| Title |
Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting β2-agonist fixed-dose combination: RE2SPOND rationale and study design
|
|---|---|
| Published in |
International Journal of Chronic Obstructive Pulmonary Disease, August 2016
|
| DOI | 10.2147/copd.s109661 |
| Pubmed ID | |
| Authors |
Stephen I Rennard, Fernando J Martinez, Klaus F Rabe, Sanjay Sethi, Emilio Pizzichini, Andrew McIvor, Shahid Siddiqui, Antonio Anzueto, Haiyuan Zhu |
| Abstract |
Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein. In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate-severe exacerbations within 12 months, and were receiving ICS/LABA FDC for ≥3 months. The primary efficacy measure is the rate of moderate or severe COPD exacerbations per participant per year. The secondary efficacy outcomes include mean change in prebronchodilator forced expiratory volume in 1 second (FEV1) over 52 weeks, rate of severe exacerbations, and rate of moderate, severe, or antibiotic-treated exacerbations. Additional assessments include spirometry, rescue medication use, the COPD assessment test, daily symptoms using the EXACT-Respiratory symptoms (E-RS) questionnaire, all-cause and COPD-related hospitalizations, and safety and pharmacokinetic measures. Across 17 countries, 2,354 participants were randomized from September 2011 to October 2014. Enrollment goal was met in October 2014, and study completion occurred in June 2016. This study will further characterize the effects of roflumilast added to ICS/LABA on exacerbation rates, lung function, and health of severe-very severe COPD participants at risk of further exacerbations. The results will determine the clinical benefits of roflumilast combined with standard-of-care inhaled COPD treatment. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 50% |
| Practitioners (doctors, other healthcare professionals) | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 51 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 51 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 7 | 14% |
| Student > Bachelor | 7 | 14% |
| Researcher | 6 | 12% |
| Student > Postgraduate | 4 | 8% |
| Professor > Associate Professor | 3 | 6% |
| Other | 7 | 14% |
| Unknown | 17 | 33% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 18 | 35% |
| Nursing and Health Professions | 4 | 8% |
| Agricultural and Biological Sciences | 3 | 6% |
| Unspecified | 2 | 4% |
| Pharmacology, Toxicology and Pharmaceutical Science | 1 | 2% |
| Other | 2 | 4% |
| Unknown | 21 | 41% |
Attention Score in Context
This research output has an Altmetric Attention Score of 45. 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 12 January 2023.
All research outputs
#914,343
of 25,373,627 outputs
Outputs from International Journal of Chronic Obstructive Pulmonary Disease
#34
of 2,577 outputs
Outputs of similar age
#17,904
of 381,036 outputs
Outputs of similar age from International Journal of Chronic Obstructive Pulmonary Disease
#2
of 102 outputs
Altmetric has tracked 25,373,627 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 96th percentile: it's in the top 5% 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 98% of its peers.
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We're also able to compare this research output to 102 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 98% of its contemporaries.