Trial reportInternational journal of chronic obstructive pulmonary disease2009
Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations.
Trial report in International journal of chronic obstructive pulmonary disease, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis.The Cochrane database of systematic reviews · 2014Pooled it
- Tiotropium versus long-acting beta-agonists for stable chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2012Pooled it
- Characterisation of exacerbation risk and exacerbator phenotypes in the POET-COPD trial.Respiratory research · 2013Trial
- Rigorous methodological approaches to address knowledge gaps in exercise, nutrition, immunity, and infection risk research.Physiological reports · 2025Review
- Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3).BMC pulmonary medicine · 2020Article
- Chronic obstructive pulmonary disease hospital admissions and drugs--unexpected positive associations: a retrospective general practice cohort study.NPJ primary care respiratory medicine · 2014Article
- The role of bronchodilator treatment in the prevention of exacerbations of COPD.The European respiratory journal · 2012Review
- Long-acting β-adrenoceptor agonists in the management of COPD: focus on indacaterol.International journal of chronic obstructive pulmonary disease · 2011Review
- Treatment of COPD: from pharmacological to instrumental therapies.European respiratory review : an official journal of the European Respiratory Society · 2010Review
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 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Currently available long-acting inhaled bronchodilators (tiotropium, salmeterol, formoterol) have demonstrated beneficial effects on exacerbations in placebo-controlled trials. However, there have been no direct comparisons of these drugs with exacerbations as the primary outcome and consequently COPD treatment guidelines do not indicate a preference for either bronchodilator. Therefore, an international, randomized, double-blind, double-dummy, parallel-group clinical trial has been designed to investigate the comparative efficacy of 2 long-acting bronchodilators tiotropium 18 microg daily and salmeterol 50 microg bid on exacerbations. The trial will include at least 6800 randomized patients with diagnosis of COPD, >or= 10 pack-year history of smoking, post-bronchodilator FEV(1) <or= 70% predicted, and a history of exacerbations in the previous year. The primary endpoint is time to first COPD exacerbation. Secondary endpoints include number of exacerbations and time to premature discontinuation of trial medication. The trial has been designed to address several of the challenges in studying exacerbations in a controlled trial by a symptom and event-based definition of exacerbations, frequent follow-up contacts, selection of time to first event as the primary endpoint and using exposure adjusted analysis when examining number of events. Other challenges in designing exacerbation trials such as differential discontinuation and follow-up of discontinued patients are discussed.
Indexed as
Identifiers
19436693PMC2672797W2172144439What OpenQuestion holds
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.