Trial reportBMC pulmonary medicine2015
Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease.
Trial report in BMC pulmonary medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00419744 (A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects), which is not on this map. Cited by 31 papers, 3 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.
A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Impact of prior and concurrent medication on exacerbation risk with long-acting bronchodilators in chronic obstructive pulmonary disease: a post hoc analysis.Respiratory research · 2019Pooled it
- Efficacy and safety of tiotropium and olodaterol in COPD: a systematic review and meta-analysis.Respiratory research · 2017Pooled it
- Rescue medication use as a patient-reported outcome in COPD: a systematic review and regression analysis.Respiratory research · 2017Pooled it
- Predictive machine learning algorithm for COPD exacerbations using a digital inhaler with integrated sensors.BMJ open respiratory research · 2025Trial
- Salbutamol use in relation to maintenance bronchodilator efficacy in COPD: a prospective subgroup analysis of the EMAX trial.Respiratory research · 2020Trial
- Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study.The European respiratory journal · 2017Trial
- Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD.International journal of chronic obstructive pulmonary disease · 2017Trial
- Early and sustained symptom improvement with umeclidinium/vilanterolTherapeutic advances in respiratory diseaseTrial
- Excessive Short-acting Beta-agonists Prescriptions in COPD Treated with Triple Inhaler Therapy: A Possible Marker of Frequent Exacerbations. A Retrospective Cohort Study.Thoracic research and practice · 2026Article
- Short-acting βERJ open research · 2025Article
- Unmet needs of patients with COPD in Germany: a retrospective, cross-sectional study.ERJ open research · 2025Article
- Article
- Development and Validation of a Quantitative Score for the Criteria Clinical Control in Stable COPD Proposed in the Spanish COPD Guidelines (GesEPOC): Results of the EPOCONSUL Audit.Journal of clinical medicine · 2025Article
- Article
- Short-Acting Beta-Agonists, Antibiotics, Oral Corticosteroids, and the Associated Burden of COPD.CHEST pulmonary · 2024Article
- High use of short-acting βERJ open research · 2023Article
- Comparison of Rescue Medication Prescriptions in Patients with Chronic Obstructive Pulmonary Disease Receiving Umeclidinium/Vilanterol versus Tiotropium Bromide/Olodaterol in Routine Clinical Practice in England.International journal of chronic obstructive pulmonary disease · 2023Article
- Risk of all-cause mortality or hospitalization for pneumonia associated with inhaled β2-agonists in patients with asthma, COPD or asthma-COPD overlap.Respiratory research · 2022Article
- Pilot Study of a Patient Experience with an ELLIPTA Inhaler Electronic Medication Monitor and Associated Integrated System: A Prospective Observational Study Using the COPD Patient-Powered Research Network.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2021Article
- Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD.NPJ primary care respiratory medicine · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDebate exists regarding which endpoints most sensitively reflect day-to-day variation in chronic obstructive pulmonary disease (COPD) symptoms and are most useful in clinical practice to predict COPD exacerbations. We hypothesized that short-acting β2-agonist (SABA) reliever use would predict short- and long-term exacerbation risk in COPD patients.
methodsWe performed a retrospective analysis of data from a study (ClinicalTrials.gov registration: NCT00419744) comparing budesonide/formoterol 320/9 μg with formoterol 9 μg (both twice daily) in patients with moderate-to-very-severe COPD; reliever salbutamol 90 μg was provided. First occurrence of reliever use >4 (low), >10 (medium), and >20 (high) inhalations/day was assessed as a predictor of short-term (3-week) exacerbation risk. Mean daily reliever use in the week preceding the 2-month visit was investigated as a predictor of the long-term (10-month) exacerbation risk, using intervals of 2-5, 6-9, and ≥10 inhalations/day.
resultsOverall, 810 patients were included (61 % male; mean age 63.2 years; post-bronchodilator forced expiratory volume in 1 s 37.7 % of predicted). First occurrence of low, medium, or high reliever use was predictive of an exacerbation within the following 3 weeks; exacerbation risk increased significantly with increasing reliever use. Mean reliever use over 1 week was predictive of long-term exacerbation risk. Patients with mean use of 2-5, 6-9, and ≥10 inhalations/day exhibited 21 %, 67 %, and 135 % higher exacerbation rates, respectively, in the following 10 months, compared with <2 inhalations/day. Budesonide/formoterol was associated with lower short- and long-term exacerbation risk than formoterol in all reliever-use groups.
conclusionsSABA reliever use is a predictor of short- and long-term exacerbation risk in moderate-to-very-severe COPD patients with a history of exacerbations receiving budesonide/formoterol or formoterol.
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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.