Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma

27. december 2017 opdateret af: Boehringer Ingelheim

A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma

The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

472

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Belgien
- - Angleur, Belgien, 4031
    - CHU Sart Tilman
  - Brussel, Belgien, 1090
    - A.Z. VUB
  - Genk, Belgien, 3600
    - Boehringer Ingelheim Investigational Site
  - Hasselt, Belgien, 3500
    - Boehringer Ingelheim Investigational Site
  - Herentals, Belgien, 2200
    - St. Elisabethziekenhuis
  - Malmedy, Belgien, 4960
    - Clinique Reine Astrid
  - Turnhout, Belgien, 2300
    - Sint-Elisabethziekenhuis
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1L8
    - VGH Research Pavillion
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - BG 034, Room C2027
- Ontario
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Department of Medicine, Health Sciences Centre
  - Mississauga, Ontario, Canada, L5B 1N1
    - Boehringer Ingelheim Investigational Site
  - Toronto, Ontario, Canada, M5S 2A5
    - Boehringer Ingelheim Investigational Site
  - Toronto, Ontario, Canada, M5T 2S8
    - Respiratory Research Lab
  - Toronto, Ontario, Canada, M6H 3M2
    - Boehringer Ingelheim Investigational Site
  - Toronto, Ontario, Canada, M6M 2J5
    - Department of Respiratory Medicine
- Quebec
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Centre de Recherche Clinique -CUSE
  - Ste-Foy, Quebec, Canada, G1V 4G5
    - Hopital Laval
Danmark
- - Aarhus, Danmark, DK-8000
    - Lungemedicinsk Forskning 2B
  - Hellerup, Danmark, 2900
    - Lungemedicinsk afdeling Y
  - Hiller?d, Danmark, 3400
    - Medicinsk afdeling B0642
  - Hvidovre, Danmark, DK-2650
    - Lungemedicinsk Klinik
  - K?benhavn NV, Danmark, 2400
    - H:S Bispebjerg Hospital
  - Odense C, Danmark, 5000
    - Lungemedicinsk Forskning
Frankrig
- - Annecy, Frankrig, 74000
    - Hôpital d'Annecy
  - Antony cedex, Frankrig, 92166
    - Hôpital Privé Antony
  - Chamalieres, Frankrig, 66400
    - Boehringer Ingelheim Investigational Site
  - Clermont Ferrand cedex 1, Frankrig, 63003
    - Hôpital Gabriel Montpied
  - Marseille, Frankrig, 13291
    - Hôpital Ambroise Paré
  - Metz cedex 1, Frankrig, 57038
    - Hôpital Notre Dame de Bon Secours
  - Montpellier, Frankrig, 34295
    - Hopital Arnaud de Villeneuve
  - Montpellier, Frankrig, 34070
    - Boehringer Ingelheim Investigational Site
  - Nantes, Frankrig, 44000
    - Boehringer Ingelheim Investigational Site
  - Nantes, Frankrig, 44000
    - Centre Medical Erdre St Augustin
  - Nice, Frankrig, 06000
    - Boehringer Ingelheim Investigational Site
  - Reims cedex, Frankrig, 51092
    - Hopital Maison Blanche
Holland
- - Almelo, Holland, 7609 PP
    - Ziekenhuisgroep Twent
  - Breda, Holland, 4819 EV
    - Amphia Ziekenhuis
  - Heerlen, Holland, 6419 PC
    - Atrium medisch centrum
  - Hengelo, Holland, 7555 DL
    - Ziekenhuigroep Twente
  - Leeuwarden, Holland, 8934 AD
    - Medisch Centrum Leeuwarden
  - Sneek, Holland, 8601 ZK
    - Antonius ziekenhuis
  - Velthoven, Holland, 5505 DB
    - Maxima Medisch Centrum
Italien
- - Ferrara, Italien, 44100
    - A. O. Universitaria di Ferrara - Arcispedale S. Anna
  - Genova, Italien, 16132
    - Università di Genova
  - Genova, Italien, 16132
    - A.O. S. Martino e Cliniche Universitarie di Genova
  - Pisa, Italien, 56100
    - A.O. Pisana
Sydafrika
- - Bellville, Sydafrika, 7530
    - Boehringer Ingelheim Investigational Site
  - Cape Town, Sydafrika, 7700
    - Boehringer Ingelheim Investigational Site
  - Cape Town, Sydafrika, 8001
    - Boehringer Ingelheim Investigational Site
  - Durban, Sydafrika, 4001
    - Boehringer Ingelheim Investigational Site
  - George, Sydafrika, 6529
    - Boehringer Ingelheim Investigational Site
  - Paarl, Sydafrika, 7646
    - Boehringer Ingelheim Investigational Site
  - Pretoria, Sydafrika, 0001
    - Boehringer Ingelheim Investigational Site
  - Somerset West, Sydafrika, 7130
    - Boehringer Ingelheim Investigational Site
Tyskland
- - Berlin, Tyskland, 14057
    - MEDARS GmbH
  - Berlin, Tyskland, 12203
    - Boehringer Ingelheim Investigational Site
  - Berlin, Tyskland, 12687
    - Boehringer Ingelheim Investigational Site
  - Bonn, Tyskland, 53119
    - Boehringer Ingelheim Investigational Site
  - Frankfurt/Main, Tyskland, 60323
    - Boehringer Ingelheim Investigational Site
  - Furth, Tyskland, 90762
    - Boehringer Ingelheim Investigational Site
  - Gauting, Tyskland, 82131
    - Inamed Research GmbH & Co. KG
  - Gelnhausen, Tyskland, 63571
    - Boehringer Ingelheim Investigational Site
  - Gorlitz, Tyskland, 02826
    - ClinPharm Internat. GmbH & Co. KG
  - Hamburg, Tyskland, 20535
    - Pneumologisches Forschungsinstitut GmbH am Krankenhaus
  - Koln, Tyskland, 50924
    - Med. Einrichtung der Universitat zu Koln
  - Minden, Tyskland, 32423
    - Boehringer Ingelheim Investigational Site
  - Munchen, Tyskland, 80335
    - Boehringer Ingelheim Investigational Site
  - Rudersdorf, Tyskland, 15562
    - Boehringer Ingelheim Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

Diagnosis of COPD and diagnosis of asthma before the age of 30
Current or ex-smokers with a cigarette smoking history of at least 10 pack-years
Treatment with inhaled steroids at least 1 year before study entry
FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years
Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1
Post bronchodilator FEV1 less than 70% of FVC at visit 1

Exclusion criteria:

Respiratory infection or exacerbation 6 weeks prior to Visit 1 or during run-in period.
Significant diseases other than COPD or asthma
Myocardial infarction within the last 6 months
Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
Hospitalisation for heart failure (NYHA Class III or IV) within the last year
History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Known active tuberculosis
History of thoracotomy with pulmonary resection
History of cancer within the last 5 years (excluding treated basal cell carcinoma)
Patients requiring oxygen therapy for more than 1 hour per day
Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1
Known hypersensitivity to anticholinergic drugs or lactose

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose) Tidsramme: after 12 weeks of treatment	after 12 weeks of treatment

Sekundære resultatmål

Resultatmål	Tidsramme
Forekomst af uønskede hændelser Tidsramme: 12 uger	12 uger
Brug af redningsmedicin Tidsramme: 12 uger	12 uger
Forced vital capacity (FVC) Tidsramme: 12 weeks	12 weeks
Peak expiratory flow rate (PEFR) Tidsramme: 12 weeks	12 weeks
AUC0-6hFEV1 Tidsramme: after first dose on Day 1 and after 4 weeks of treatment	after first dose on Day 1 and after 4 weeks of treatment
Change in trough FEV1 (i.e. trough response) from baseline. Tidsramme: after 4 and 12 weeks of treatment	after 4 and 12 weeks of treatment
Change in peak FEV1 from baseline (=peak response) after first dose Tidsramme: after 4 and 12 weeks of treatment	after 4 and 12 weeks of treatment
AUC0-6hFVC defined in the same way as for FEV1. Tidsramme: Day 1, week 4	Day 1, week 4
Trough FVC defined in the same way as for FEV1. Tidsramme: Day 1, week 4	Day 1, week 4
Peak FVC defined in the same way as for FEV1 Tidsramme: Day 1, week 4	Day 1, week 4
Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement). Tidsramme: 12 weeks	12 weeks
Weekly average number of puffs of rescue medication used Tidsramme: 12 weeks	12 weeks
Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry Tidsramme: 12 weeks	12 weeks
Change from baseline in Physical examination Tidsramme: 12 weeks	12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2004

Primær færdiggørelse (Faktiske)

1. april 2006

Studieafslutning (Faktiske)