title: Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).

summary:
This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits.

The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations.

The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation.

The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator.

Only COPD exacerbations with onset during randomised treatment will be included in the analysis.

design_allocation: Randomized

ReferenceCitation: Vogelmeier CF, Asijee GM, Kupas K, Beeh KM. Tiotropium and Salmeterol in COPD Patients at Risk of Exacerbations: A Post Hoc Analysis from POET-COPD(®). Adv Ther. 2015 Jun;32(6):537-47. doi: 10.1007/s12325-015-0216-2. Epub 2015 Jun 23.

family: Vogelmeier

full_name: Claus F. Vogelmeier

given: Claus F.

family: Asijee

full_name: Guus M. Asijee

given: Guus M.

family: Kupas

full_name: Katrin Kupas

given: Katrin

family: Beeh

full_name: Kai M. Beeh

given: Kai M.

journal_name: Advances in Therapy

oa_colors: green hybrid

evidence: open (via page says license)

license: implied-oa

license_normalized: implied-oa

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Tiotropium and Salmeterol in COPD Patients at Risk of Exacerbations: A Post Hoc Analysis from POET-COPD®

ReferenceCitation: Rabe KF, Fabbri LM, Israel E, Kögler H, Riemann K, Schmidt H, Glaab T, Vogelmeier CF. Effect of ADRB2 polymorphisms on the efficacy of salmeterol and tiotropium in preventing COPD exacerbations: a prespecified substudy of the POET-COPD trial. Lancet Respir Med. 2014 Jan;2(1):44-53. doi: 10.1016/S2213-2600(13)70248-0. Epub 2013 Dec 5.

family: Rabe

full_name: Klaus F Rabe

given: Klaus F

family: Fabbri

full_name: Leonardo M Fabbri

given: Leonardo M

family: Israel

full_name: Elliot Israel

given: Elliot

family: Kögler

full_name: Harald Kögler

given: Harald

family: Riemann

full_name: Kathrin Riemann

given: Kathrin

family: Schmidt

full_name: Hendrik Schmidt

given: Hendrik

family: Glaab

full_name: Thomas Glaab

given: Thomas

full_name: Claus F Vogelmeier

given: Claus F

journal_name: The Lancet Respiratory Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Beeh KM, Glaab T, Stowasser S, Schmidt H, Fabbri LM, Rabe KF, Vogelmeier CF. Characterisation of exacerbation risk and exacerbator phenotypes in the POET-COPD trial. Respir Res. 2013 Oct 29;14:116. doi: 10.1186/1465-9921-14-116.

full_name: Kai M Beeh

given: Kai M

ReferenceCitation: Rabe KF, Fabbri LM, Vogelmeier C, Kögler H, Schmidt H, Beeh KM, Glaab T. Seasonal distribution of COPD exacerbations in the Prevention of Exacerbations with Tiotropium in COPD trial. Chest. 2013 Mar;143(3):711-719. doi: 10.1378/chest.12-1277.

title: Seasonal Distribution of COPD Exacerbations in the Prevention of Exacerbations With Tiotropium in COPD Trial

ReferenceCitation: Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Mölken MP, Beeh KM, Rabe KF, Fabbri LM; POET-COPD Investigators. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011 Mar 24;364(12):1093-1103. doi: 10.1056/NEJMoa1008378.

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

title: Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD

ReferenceCitation: Beeh KM, Hederer B, Glaab T, Müller A, Rutten-van Moelken M, Kesten S, Vogelmeier C. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations. Int J Chron Obstruct Pulmon Dis. 2009;4:119-25. Epub 2009 Apr 15.

location_country:
Finland
Romania
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
France
Poland
Lithuania
Slovakia
Norway
Slovenia
Netherlands
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Israel
Spain
Turkey
Latvia

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ReferenceType: derived

ReferenceCitation: Gathe J, Andrade-Villanueva J, Santiago S, Horban A, Nelson M, Cahn P, Bogner J, Spencer D, Podzamczer D, Yong CL, Nguyen T, Zhang W, Drulak M, Quinson AM. Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients. Antivir Ther. 2011;16(5):759-69. doi: 10.3851/IMP1803.

family: Gathe

full_name: Joseph Gathe

given: Joseph

sequence: first

family: Andrade-Villanueva

full_name: Jaime Andrade-Villanueva

given: Jaime

sequence: additional

family: Santiago

full_name: Steven Santiago

given: Steven

family: Horban

full_name: Andrzej Horban

given: Andrzej

family: Nelson

full_name: Mark Nelson

given: Mark

family: Cahn

full_name: Pedro Cahn

given: Pedro

family: Bogner

full_name: Johannes Bogner

given: Johannes

family: Spencer

full_name: David Spencer

given: David

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

family: Yong

full_name: Chan-Loi Yong

given: Chan-Loi

family: Nguyen

full_name: Thuy Nguyen

given: Thuy

family: Zhang

full_name: Wei Zhang

given: Wei

family: Drulak

full_name: Murray Drulak

given: Murray

family: Quinson

full_name: Anne-Marie Quinson

given: Anne-Marie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Antiviral Therapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Boehringer Ingelheim

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Romania
Belgium
Australia
Russian Federation
France
Poland
Argentina
Canada
South Africa
Switzerland
Netherlands
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Botswana
Mexico
Spain

acronym: VERVE

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type: EudraCT Number

source: euctr

title: A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)

summary: The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

lead_sponsor_type: industriel

status_simplified: Completed


title: An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

summary: The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

location_country:
South Africa
Sweden
Netherlands
Philippines
Finland
France
Norway
Belgium
Denmark
Canada
Korea, Republic of
Taiwan

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location_facility: 1235.5.27003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307F Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20013 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301J Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45006 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20009 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.88601 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63007 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307E Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45008 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3306D Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3303C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82007 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3308A Boehringer Ingelheim Investigational Site

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location_facility: 1235.5.31008 Boehringer Ingelheim Investigational Site

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title: Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma

summary: The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

study_completion_date_type: Actual

lead_sponsor: AstraZeneca

location_country: Italy India France Hungary Germany Canada


title: Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma

summary: The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

location_country:
Italy
Switzerland
Netherlands
France
Belgium
Spain
United Kingdom


title: Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

acronym: NATURE

summary: Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.

study_type: Observational

time_perspective: Prospective

lead_sponsor: LivaNova

location_country:
Italy
United States
Spain
Germany
France
Japan
Belgium
Portugal
Denmark
Canada
Korea, Republic of

location_facility: University of Mississippi Medical Center

location_facility: Kanagawa Cardiov. and Respiratory Center

location_facility: Nara Hospital, Kinki University School of Medicine


title: A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain

summary: The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.

status: Terminated

study_completion_date_type: Anticipated

ReferenceCitation: Michael BD, Syndikus I, Clark A, Baborie A. Diffuse primary leptomeningeal melanocytosis in a patient receiving a novel cancer cell vaccine for prostate cancer. BMJ Case Rep. 2010 May 4;2010. pii: bcr1120092495. doi: 10.1136/bcr.11.2009.2495.

family: Michael

full_name: B. D. Michael

given: B. D.

family: Syndikus

full_name: I. Syndikus

given: I.

family: Clark

full_name: A. Clark

given: A.

family: Baborie

full_name: A. Baborie

journal_name: Case Reports

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Cell Genesys

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Poland
Belgium
Canada
United Kingdom

location_facility: Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen

location_facility: Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz

location_facility: Ziekenhuis Netwerk Antwerpen - AZ Middelheim

location_facility: General Clinical Research Center University of Michigan

location_facility: Cancer Center and Department of Medicine

location_facility: Institut Jean Godinot, Oncologie Medicale

location_facility: North Shore Hematology Oncology Associates P.C.

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera Maggiore della Carita

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie

location_facility: Katedra i Klinika Onkologii i Radioterapli

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Centre Hospitalier Universite de Sherbrooke

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu

location_facility: Presbyterian Hospital Center for Cancer Research

location_facility: Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Seattle Cancer Care Alliance, Univ. of Washington

location_facility: Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara

location_facility: Peachtree Hematology & Oncology Consultants, PC

location_facility: Centre Hospitalier de L'Universite de Montreal

location_facility: Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne

location_facility: Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer

location_facility: Centre Rene Gauducheau - Site Hospitalier Nord

location_facility: Scunthorpe General Hospital, Dept of Oncology

location_facility: Desert Hematology Oncology Medical Group

location_facility: Rosemere Cancer Centre, Royal Preston Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Universitatsklinikum Carl Gustav Carus An Der

location_facility: Wojewodzki Szpital Specjalistyczny Oddzial Urologii

location_facility: Center for Oncology Research & Treatment, PA

location_facility: Kaiser Permanente Medical Group Dept. of Oncology Research

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: Jupiter Hematology & Oncology Associates

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Wojewodzki Szpital Specjalistyczny w Siedlcach

location_facility: Department of Oncology Hammersmith Hospital

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Klinikum der Johann Wolfgang Goethe-Universitat

status_simplified: Unknown