title: 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)

summary: Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

ReferenceCitation: Wise RA, Calverley PM, Carter K, Clerisme-Beaty E, Metzdorf N, Anzueto A. Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR(R) trial. Int J Chron Obstruct Pulmon Dis. 2018 Feb 14;13:605-616. doi: 10.2147/COPD.S148393. eCollection 2018.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Calverley PMA, Mueller A, Fowler A, Metzdorf N, Wise RA. The Effect of Defining Chronic Obstructive Pulmonary Disease by the Lower Limit of Normal of FEV1/FVC Ratio in Tiotropium Safety and Performance in Respimat Participants. Ann Am Thorac Soc. 2018 Feb;15(2):200-208. doi: 10.1513/AnnalsATS.201703-194OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Dahl R, Calverley PM, Anzueto A, Metzdorf N, Fowler A, Mueller A, Wise R, Dusser D. Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial. BMJ Open. 2015 Dec 29;5(12):e009015. doi: 10.1136/bmjopen-2015-009015.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_concat: PubMed Central;sdu.dk

publisher_dissemination: British Medical Journal

ReferenceCitation: Anzueto A, Wise R, Calverley P, Dusser D, Tang W, Metzdorf N, Dahl R. The Tiotropium Safety and Performance in Respimat(R) (TIOSPIR(R)) Trial: Spirometry Outcomes. Respir Res. 2015 Sep 15;16(1):107. doi: 10.1186/s12931-015-0269-4.

ReferenceCitation: Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B, Dusser D, Joseph E, Kattenbeck S, Koenen-Bergmann M, Pledger G, Calverley P; TIOSPIR Investigators. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013 Oct 17;369(16):1491-501. doi: 10.1056/NEJMoa1303342. Epub 2013 Aug 30.

evidence: open (via free article)

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acronym: REMARC

intervention_type: Drug

lead_sponsor: The Lymphoma Academic Research Organisation

summary:
This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy

For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.

ReferenceType: derived

ReferenceCitation: Cottereau AS, Meignan M, Nioche C, Capobianco N, Clerc J, Chartier L, Vercellino L, Casasnovas O, Thieblemont C, Buvat I. Risk stratification in diffuse large B-cell lymphoma using lesion dissemination and metabolic tumor burden calculated from baseline PET/CTdagger. Ann Oncol. 2021 Mar;32(3):404-411. doi: 10.1016/j.annonc.2020.11.019. Epub 2020 Dec 3.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Vercellino L, Cottereau AS, Casasnovas O, Tilly H, Feugier P, Chartier L, Fruchart C, Roulin L, Oberic L, Pica GM, Ribrag V, Abraham J, Simon M, Gonzalez H, Bouabdallah R, Fitoussi O, Sebban C, Lopez-Guillermo A, Sanhes L, Morschhauser F, Trotman J, Corront B, Choufi B, Snauwaert S, Godmer P, Briere J, Salles G, Gaulard P, Meignan M, Thieblemont C. High total metabolic tumor volume at baseline predicts survival independent of response to therapy. Blood. 2020 Apr 16;135(16):1396-1405. doi: 10.1182/blood.2019003526.

oa_colors: green other

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

location_facility: Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner

location_facility: Frankston Hospital Monash Medical Centre

location_facility: SPZOZ Zespol Szpitali Miejskich w Chorzowie

location_facility: Universite Catholique de Louvain Mont Godinne

location_facility: Universitätklinik der PMU Salzburg - Für Innere Medizin III

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Hospital Général Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Mater Misericordiae Hospital - Calvary Mater NewCastle

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii

location_facility: AZ Groeninge - Campus Maria s Voorzienigheid

location_facility: Hopital Universitario Virgen de la Arrixaca

location_facility: Klinika Hematologii Collegium Medicum UJ

location_facility: Albury Base Hospital/Murray Valley Private Hospital

location_facility: Flinders Medical Centre - Repatriation General Hospital

location_facility: LKH Leoben-Eisenerz Department für Hämato-Onkologie

location_facility: Landeskrankenhaus Steyr - Innere Medizin II

location_facility: Complejo Hospitalario Universitario de A Coruna

location_facility: AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un

location_facility: Instituto Português de Oncologia de Lisboa de Francisco Gentil

location_facility: Universite Catholique de Louvain Saint Luc

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny

location_facility: Medizinische Universität Innsbruck für Innere Medizin

location_facility: Hôpital des instructions des Armées PERCY

status: Completed

title: Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country: France Poland Portugal Australia Switzerland Austria Belgium Spain Israel

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Completed