Trial reportInternational journal of chronic obstructive pulmonary disease2012
Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol.
Trial report in International journal of chronic obstructive pulmonary disease, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01329029 (Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2020Pooled it
- Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2017Pooled it
- Adherence to roflumilast under dose-escalation strategy in Korean patients with COPD.International journal of chronic obstructive pulmonary disease · 2019Trial
- Pharmacokinetic and Pharmacodynamic Modelling to Characterize the Tolerability of Alternative Up-Titration Regimens of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease.Clinical pharmacokinetics · 2018Trial
- Use of a 4-week up-titration regimen of roflumilast in patients with severe COPD.International journal of chronic obstructive pulmonary disease · 2018Trial
- Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting β2-agonist fixed-dose combination: RE(2)SPOND rationale and study design.International journal of chronic obstructive pulmonary disease · 2016Trial
- A Randomized, Placebo-controlled Trial of Roflumilast. Effect on Proline-Glycine-Proline and Neutrophilic Inflammation in Chronic Obstructive Pulmonary Disease.American journal of respiratory and critical care medicine · 2015Trial
- The Role of the Pharmacist in Optimizing Outcomes With Roflumilast, a PDE4 Inhibitor for the Treatment of COPD.Journal of pharmacy practice · 2022Review
- Towards precision in defining COPD exacerbations.Breathe (Sheffield, England) · 2021Review
- Handling underlying discrete variables with bivariate mixed hidden Markov models in NONMEM.Journal of pharmacokinetics and pharmacodynamics · 2019Article
- Chronic Obstructive Pulmonary Disease: Clinical Implications for Patients With Lung CancerClinical journal of oncology nursing · 2018Article
- Roles of roflumilast, a selective phosphodiesterase 4 inhibitor, in airway diseases.Journal of thoracic disease · 2017Review
- Roflumilast: a review of its use in the treatment of COPD.International journal of chronic obstructive pulmonary disease · 2016Review
- Article
- Potential mechanisms to explain how LABAs and PDE4 inhibitors enhance the clinical efficacy of glucocorticoids in inflammatory lung diseases.F1000prime reports · 2015Review
- Impact of roflumilast on exacerbations of COPD, health care utilization, and costs in a predominantly elderly Medicare Advantage population.International journal of chronic obstructive pulmonary disease · 2015Article
- Rebuttal from Dr Rho et al.Chest · 2014Article
- Vulnerable COPD patients with comorbidities: the role of roflumilast.Therapeutics and clinical risk management · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMany patients with chronic obstructive pulmonary disease (COPD) continue to suffer exacerbations, even when treated with maximum recommended therapy (eg, inhaled combinations of long-acting β2-agonist and high dose inhaled corticosteroids, with or without a long-acting anticholinergic [long-acting muscarinic antagonist]). Roflumilast is approved to treat severe COPD in patients with chronic bronchitis--and a history of frequent exacerbations--as an add-on to bronchodilators. PURPOSE: The REACT (Roflumilast in the Prevention of COPD Exacerbations While Taking Appropriate Combination Treatment) study (identification number RO-2455-404-RD, clinicaltrials. gov identifier NCT01329029) will investigate whether roflumilast further reduces exacerbations when added to inhaled combination therapy in patients still suffering from frequent exacerbations. PATIENTS AND
methodsREACT is a 1-year randomized, double-blind, multicenter, phase III/IV study of roflumilast 500 μg once daily or placebo on top of a fixed long-acting β2-agonist/inhaled corticosteroid combination. A concomitant long-acting muscarinic antagonist will be allowed at stable doses. The primary outcome is the rate of moderate or severe COPD exacerbations. Using a Poisson regression model with a two-sided significance level of 5%, a sample size of 967 patients per treatment group is needed for 90% power. COPD patients with severe to very severe airflow limitation, symptoms of chronic bronchitis, and at least two exacerbations in the previous year will be recruited.
conclusionIt is hypothesized that because roflumilast (a phosphodiesterase-4 inhibitor) has a different mode of action to bronchodilators and inhaled corticosteroids, it may provide additional benefits when added to these treatments in frequent exacerbators. REACT will be important to determine the role of roflumilast in COPD management. Here, the design and rationale for this important study is described.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.