The Tiotropium Safety and Performance in Respimat® Trial (TIOSPIR®), a large scale, randomized, controlled, parallel-group trial-design and rationale

Wise, Robert A.; Anzueto, Antonio; Calverley, Peter M.A.; Dahl, Ronald; Dusser, Daniel; Pledger, Gordon; Koenen-Bergmann, Michael; Joseph, Elizabeth; Cotton, Daniel; Disse, Bernd

doi:10.1186/1465-9921-14-40

Cited by 53 publications

(55 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In the TIOSPIR trial, some seven inclusion and 29 exclusion criteria were applied to define the study population . In total, 21 of these criteria were reproducible in our database.…”

Section: Methodsmentioning

confidence: 99%

Tiotropium Respimat^®vs. HandiHaler^®: real‐life usage and TIOSPIR trial generalizability

Schmiedl

Fischer

Ibáñez

et al. 2015

Brit J Clinical Pharma

View full text Add to dashboard Cite

AIMTwo inhaler devices (Respimat® and HandiHaler®) are available for tiotropium, a long acting anticholinergic agent. We aimed to analyze drug utilization, off-label usage and generalizability of the TIOSPIR trial results for both devices. METHODSPatients aged ≥18 years exhibiting at least one documented prescription of tiotropium in the database of the Association of Statutory Health Insurance Physicians, Bavaria, Germany, were included (years 2004-2008). Annual period prevalence rates (PPRs) were calculated stratified by age, gender and inhaler devices. Offlabel usage (patients lacking a chronic obstructive pulmonary disease (COPD) diagnosis) and the proportion of patients meeting the inclusion and exclusion criteria of the TIOSPIR trial were analyzed. RESULTSBetween 2004 and 2008, PPRs increased and varied between 49.2 and 74.5 per 10 000 persons for HandiHaler® and between 1.5 and 9.3 per 10 000 persons for Respimat®. Small differences regarding patient characteristics existed between the two inhaler devices. Only about 30% (HandiHaler® 32.1%, Respimat® 30.0%) of the database patients receiving tiotropium could be theoretically included in the TIOSPIR trial. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• After the TIOSPIR trial, there were still some safety concerns regarding tiotropium Respimat® in, for example, cardiovascular patients.• Comparing characteristics of patients receiving tiotropium Respimat® or HandiHaler® is crucial in identifying populations at risk.• Up to now, generalizability of TIOSPIR trial results to a real-life population is unclear, hampering risk-benefit weighting. CONCLUSIONSComparing the two tiotropium devices, no clinically relevant differences regarding patient and prescribing characteristics were revealed. Results of the TIOSPIR trial were generalizable only to a minority of our study patients, underlining the need for real-life data.

show abstract

“…In the TIOSPIR trial, some seven inclusion and 29 exclusion criteria were applied to define the study population . In total, 21 of these criteria were reproducible in our database.…”

Section: Methodsmentioning

confidence: 99%

Tiotropium Respimat^®vs. HandiHaler^®: real‐life usage and TIOSPIR trial generalizability

Schmiedl

Fischer

Ibáñez

et al. 2015

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…The TIOSPIR (Tiotropium Safety and Performance in Respimat) trial (NCT01126437) in 17 135 patients with COPD confirmed that the safety profiles of tiotropium 5 µg and 2.5 µg delivered via the Respimat inhaler (hereinafter referred to as tiotropium Respimat) were comparable with those of tiotropium 18 μg delivered via the Spiriva HandiHaler device [53]. A number of studies have now evaluated the efficacy of tiotropium Respimat compared with placebo, each as an add-on to usual care with at least ICS in patients with symptomatic asthma.…”

Section: Tiotropium Add-on Therapy Delivered Via the Respimat Soft MImentioning

confidence: 79%

Long-acting muscarinic antagonists: a potential add-on therapy in the treatment of asthma?

et al. 2016

Self Cite

View full text Add to dashboard Cite

Asthma is a chronic inflammatory disorder of the airways that is a major global burden on both individuals and healthcare systems. Despite guideline-directed treatment, a significant proportion of patients with asthma do not achieve control. This review focuses on the potential use of long-acting anticholinergics as bronchodilators in the treatment of asthma, with results published from clinical trials of glycopyrrolate, umeclidinium and tiotropium. The tiotropium clinical trial programme is the most advanced, with data available from a number of phase II and III studies of tiotropium as an add-on to inhaled corticosteroid maintenance therapy, with or without a long-acting β 2 -agonist, in patients across asthma severities. Recent studies using the Respimat Soft Mist inhaler have identified 5 µg once daily as the preferred dosing regimen, which has shown promising results in adults, adolescents and children with asthma. Tiotropium Respimat has recently been incorporated into the Global Initiative for Asthma 2015 treatment strategy as a recommended alternative therapy at steps 4 and 5 in adult patients with a history of exacerbations. The increasing availability of evidence from ongoing and future clinical trials will be beneficial in determining where long-acting anticholinergic agents fit in future treatment guidelines across a variety of patient populations and disease severities. @ERSpublications Anticholinergics as an add-on to current treatment options may address the current unmet need in asthma management http://ow.ly/TTi1E

show abstract

“…But, subsequently a larger randomised-controlled trial comparing this effect in patients receiving tiotropium by Respimat or HandiHaler (which was deemed to be safe by the time), found no difference as far as mortality due to device was concerned. 21,22 Searching Newer Therapeutic Targets-COPD is a systemic disease and has different arms of pathogenesis. In due consideration, the treatment demands the search of such therapeutic targets other than the conventional bronchodilators namely LABAs and LAMAs.…”

Section: Review Of Literature Newer Innovations In Pharmacotherapy-mentioning

confidence: 99%

Pharmacotherapy in Copd- Recent Innovations and Research

Choubey¹,

Ghewade²

2017

jebmh

View full text Add to dashboard Cite

BACKGROUND COPD remains to be one of the major and increasing health problems worldwide. The treatment approach needs to be multidimensional, but pharmacotherapy claims the superiority though demands more rationalisation in terms of patient selections, dosing, authentication of new innovative molecules and drug delivery systems. Here, we present a review of various recent studies on pharmacotherapy of COPD done by searching through the PubMed, Google Scholar, Cochrane, along with the FDA website for the newer drug approvals. We selected the highly relevant articles on the newly-approved drugs and pivotal and post hoc studies and reviews related to them. In newer innovations, both tiotropium and indacaterol were compared and there was favourable difference in case of tiotropium in preventing exacerbations. In the search of newer therapeutic targets phosphodiesterase inhibition, two studies showed increase in the prebronchodilator FEV1 by 48 mL. REACT trial showed that the exacerbation was lowered by 13.2% by roflumilast. In infectious exacerbations, two trials MACRO and COLUMBUS study showed beneficial effect of azithromycin in the frequency of exacerbations. Calculating the pharmacotherapeutic risks, TORCH study showed that those who are receiving ICS, the development of pneumonias was more common with elderly fellows. Azithromycin is associated with cardiac-related deaths and hearing loss. On individualised treatment approach, WISDOM study showed that there was no significant difference in exacerbation rates once the ICS is withdrawn in the two groups, i.e. LABA/ICS combination and a LAMA for six weeks.In conclusion, devising rational treatment for COPD is of paramount importance. Treatment strategy will depend on severity of the obstruction and acute exacerbations. More severe disease needs more extensive approach possibly the inclusion of antiinflammatory drugs, which can be gradually withdrawn. ICS benefits the patients in terms of exacerbations without any significant changes in the lung functions. They do so more in patients with more asthma like history, but again there is risk of pneumonia especially with fluticasone preparations. LAMAs do better than LABAs in COPD. Newer innovations like long-term antibiotics and PDE IV inhibitors maybe add on choice for not responding patients.

show abstract

The Tiotropium Safety and Performance in Respimat® Trial (TIOSPIR®), a large scale, randomized, controlled, parallel-group trial-design and rationale

Cited by 53 publications

References 10 publications

Tiotropium Respimat^®vs. HandiHaler^®: real‐life usage and TIOSPIR trial generalizability

Tiotropium Respimat^®vs. HandiHaler^®: real‐life usage and TIOSPIR trial generalizability

Long-acting muscarinic antagonists: a potential add-on therapy in the treatment of asthma?

Pharmacotherapy in Copd- Recent Innovations and Research

Contact Info

Product

Resources

About

The Tiotropium Safety and Performance in Respimat® Trial (TIOSPIR®), a large scale, randomized, controlled, parallel-group trial-design and rationale

Cited by 53 publications

References 10 publications

Tiotropium Respimat®vs. HandiHaler®: real‐life usage and TIOSPIR trial generalizability

Tiotropium Respimat®vs. HandiHaler®: real‐life usage and TIOSPIR trial generalizability

Long-acting muscarinic antagonists: a potential add-on therapy in the treatment of asthma?

Pharmacotherapy in Copd- Recent Innovations and Research

Contact Info

Product

Resources

About

Tiotropium Respimat^®vs. HandiHaler^®: real‐life usage and TIOSPIR trial generalizability

Tiotropium Respimat^®vs. HandiHaler^®: real‐life usage and TIOSPIR trial generalizability