Trial reportRespiratory research2013
The Tiotropium Safety and Performance in Respimat Trial (TIOSPIR), a large scale, randomized, controlled, parallel-group trial-design and rationale.
Trial report in Respiratory research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01126437 (A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler), which is not on this map. Cited by 27 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.
A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A systematic review of comparative studies of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease: does inhaler choice matter?BMC pulmonary medicine · 2016Pooled it
- Comparative efficacy of inhaled medications (ICS/LABA, LAMA, LAMA/LABA and SAMA) for COPD: a systematic review and network meta-analysis.International journal of chronic obstructive pulmonary diseasePooled it
- Long-term safety of tiotropium/olodaterol in older patients with moderate-to-very-severe COPD in the TONADO® studies.NPJ primary care respiratory medicine · 2020Trial
- Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial.Respiratory research · 2020Trial
- Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIRInternational journal of chronic obstructive pulmonary disease · 2018Trial
- Determinants of exacerbation risk in patients with COPD in the TIOSPIR study.International journal of chronic obstructive pulmonary disease · 2017Trial
- Tiotropium Respimat(®) Versus HandiHaler(®): Comparison of Bronchodilator Efficacy of Various Doses in Clinical Trials.Advances in therapy · 2016Trial
- Differences in outcomes between GOLD groups in patients with COPD in the TIOSPIR(®) trial.International journal of chronic obstructive pulmonary disease · 2016Trial
- Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial.BMJ open · 2015Trial
- Safety and efficacy of tiotropium Respimat versus HandiHaler in patients naive to treatment with inhaled anticholinergics: a post hoc analysis of the TIOSPIR trial.NPJ primary care respiratory medicine · 2015Trial
- The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes.Respiratory research · 2015Trial
- Cardiac safety of tiotropium in patients with cardiac events: a retrospective analysis of the UPLIFT® trial.Respiratory research · 2015Trial
- Real world pharmacovigilance study of FDA adverse event reporting system events for Spiriva Respimat.Frontiers in medicine · 2026Article
- Mortality and Exacerbation Risk by Body Mass Index in Patients with COPD in TIOSPIR and UPLIFT.Annals of the American Thoracic Society · 2022Article
- Investigation of the Clinical, Radiological and Biological Factors Associated with Disease Progression, Phenotypes and Endotypes of COPD in China (COMPASS): study design, protocol and rationale.ERJ open research · 2021Article
- Healthcare Resource Utilization, Exacerbations, and Readmissions Among Medicare Patients with Chronic Obstructive Pulmonary Disease After Long-Acting Muscarinic Antagonist Therapy Initiation with Soft Mist versus Dry Powder Inhalers.International journal of chronic obstructive pulmonary disease · 2020Article
- Discordance in investigator-reported and adjudicated sudden death in TIOSPIR.ERJ open research · 2017Article
- Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT® trial.Respiratory research · 2016Article
- Long-acting muscarinic antagonists: a potential add-on therapy in the treatment of asthma?European respiratory review : an official journal of the European Respiratory Society · 2016Review
- Tiotropium Respimat(®) vs. HandiHaler(®): real-life usage and TIOSPIR trial generalizability.British journal of clinical pharmacology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTiotropium bromide is an effective therapy for COPD patients. Comparing across programs tiotropium Respimat Soft Mist inhaler was at least as efficacious as tiotropium HandiHaler, however, concerns have been raised about tiotropium's safety when given via Respimat.
methodsThe TIOSPIR trial (NCT01126437) compares the safety and efficacy of tiotropium Respimat 5 μg once daily (marketed) and 2.5 μg once daily (investigational) with tiotropium HandiHaler 18 μ once daily (marketed). The hypotheses to be tested are 1). that tiotropium Respimat 5 μg once daily and Respimat 2.5 μg once daily are non-inferior to HandiHaler in terms of all-cause mortality, and 2). that tiotropium Respimat 5 μg once daily is superior to HandiHaler in terms of time to first exacerbation. A spirometry substudy evaluates the bronchodilator efficacy. The trial is a randomized, double-blind, double dummy, event-driven, parallel group study. Participants can use any background treatment for COPD except inhaled anticholinergic agents. The study encompasses a wide range of COPD patients, e.g. patients with stable cardiac diseases including arrhythmia can be included. Clinical sites are international and include both primary care as well as specialists.
resultsTo date, over 17,000 participants have been randomized from over 1200 sites in 50 countries with an anticipated treatment duration of 2-3 years.
conclusionTIOSPIR will provide precise estimates of the relative safety and efficacy of the Respimat and HandiHaler formulations of tiotropium, assess potential dose-dependence of important outcomes and provide information on the clinical epidemiology of COPD in a large international patient cohort.
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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.