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

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive Asthma	Drug: Placebo inhalation capsules  Drug: Tiotropium inhalation capsules	Phase IV

Further Study Details: 

Primary Outcomes: The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline at visit 2 (day 1) for the time period from pre-dose to 6 hours post dose (AUC(0-6hours)FEV1) after 12 weeks of randomised treatment on visit 4 (day 85).
Secondary Outcomes: Secondary endpoints include additional FEV1 and FVC endpoints, morning and evening exspiratory flow rate (PEFR), number of puffs of rescue medication (salbutamol), adverse events, pulse rate, systolic and diastolic blood pressure
Expected Total Enrollment:  456

The objective of this trial is to evaluate the efficacy and safety of tiotropium in a subgroup of patients with COPD and pre-existing (concomitant) diagnosis of asthma. This is a 12-week, multi-centre, multi-national, prospective, randomised, placebo controlled clinical trial. Following an initial screening at Visit 1, all patients enter a two-week screening period. Patients pretreated with commercially available Spiriva® have to be switched to ipratropium MDI q.i.d. four weeks before Visit 1. At Visit 1, reversibility testing will be performed to determine eligibility.

Patients who meet all inclusion and exclusion criteria will be randomised into the 12 week, double blind portion of the study in which they will receive either tiotropium or placebo powder capsules to be inhaled via HandiHaler® once daily in the morning. In addition, patients are allowed to continue LABAs and steroids as concomitant medication. Salbutamol (100µg per puff) will be provided as rescue medication. Patients have to record daily rescue salbutamol use on the Patient Daily Diary Card.

Pulmonary function testing will be conducted at -30 and -10 minutes prior to administration of study drug and thereafter at 30, 60 minutes and 2, 3, 4 and 6 hours post-dosing at visit 2 (day 1), visit 3 (day 29) and day 4 (day 85).

Blood samples for laboratory testing will be collected at visit 1. Adverse events will be tracked throughout the entire screening period and 12-week treatment period The objective of this study, demonstrating the superiority of 18 µg tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma can be tested using the hypotheses given below.

H0: delta(T) - delta(P) = 0 versus HA: delta(T) - delta(P) not equal to 0 where delta(T) and delta(P) represent the overall mean for the primary endpoint for tiotropium (T) and placebo (P), respectively. Testing of the null hypothesis will be performed using a 2 sided test of significance at an alpha level (type I error rate) of 0.05.

Efficacy and Safety of tiotropium inhalation capsules is compared with placebo

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Criteria

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 resersibility 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00152984

Peter Schmidt, Dr.      +49 (6132) 77-3951  Ext. 3951    SCHMIDPE@ing.boehringer-ingelheim.com

Belgium
      a.Z. VUB, Brussel,  Belgium; Recruiting
      Private Practice, Hasselt,  Belgium; Recruiting
      Sint-Elisabethziekenhuis, TURNHOUT,  Belgium; Recruiting
      Sint-Vincentius ZH, Antwerpen,  Belgium; Recruiting
      Private Practice, Genk,  Belgium; Recruiting
      A.Z. Middelheim, Antwerpen,  Belgium; Recruiting
      St. Elisabethziekenhuis, Herentals,  Belgium; Recruiting
      Clinique Reine Astrid, Malmedy,  Belgium; Recruiting
      Liège 1,  Belgium; Recruiting
Canada, Alberta
      The University of Calgary, Calgary,  Alberta,  Canada; Recruiting
Canada, British Columbia
      Vancouver General Hospital, Vancouver,  British Columbia,  Canada; Recruiting
Canada, Manitoba
      BG 034, Winnipeg,  Manitoba,  Canada; Recruiting
Canada, Ontario
      107-1670 Dufferin Street, Toronto,  Ontario,  Canada; Recruiting
      McMaster University Medical Centre, Hamilton,  Ontario,  Canada; Recruiting
      Respiratory Research Lab, Toronto,  Ontario,  Canada; Recruiting
      Suite 300, 2338 Hurontario Street, Mississauga,  Ontario,  Canada; Recruiting
      Suite 501, Toronto,  Ontario,  Canada; Recruiting
      Department of Respiratory Medicine, Toronto,  Ontario,  Canada; Recruiting
Canada, Quebec
      Hopital Laval, Ste Foy,  Quebec,  Canada; Recruiting
      Centre de Recherche Clinique -CUSE, Sherbrooke,  Quebec,  Canada; Recruiting
Denmark
      Medical Dept. B0642, Hillerød,  Denmark; Recruiting
      Odense Universitetshospital, Odense,  Denmark; Recruiting
      Ortopædkirurgisk afdeling T, Hellerup,  Denmark; Recruiting
      Lungemedicinsk Forskning 2B, Aarhus,  Denmark; Recruiting
      H:S Bispebjerg Hospital, København NV,  Denmark; Recruiting
      Hvidovre Hospital, Hvidovre,  Denmark; Recruiting
France, F
      CHU Gabriel Montpied, Clermont-Ferrand,  F,  France; Recruiting
      Centre Hospitalier Universitaire, Reims,  F,  France; Completed
      Centre Médical, Nantes,  F,  France; Recruiting
      Cabinet Médical, Nantes,  F,  France; Recruiting
      Hôpital Privé Antony, Antony,  F,  France; Recruiting
      CHR d''''Annecienne, Annecy,  F,  France; Completed
      Cabinet Médical de Pneumologie, Nice,  F,  France; Recruiting
      Dr LEGENDRE Marc, Chamalières,  F,  France; Recruiting
      Hôpital Arnaud de Villeneuve, Montpellier,  F,  France; Recruiting
      Centre Hospitalier Metz Thionville, Metz,  F,  France; Recruiting
      Hôpital Ambroise Paré, Marseille,  F,  France; Recruiting
      Clinique Clémentville, Montpellier,  F,  France; Not yet recruiting
Germany
      Dr. med. Winfried Schröder-Babo, Gelnhausen,  Germany; Recruiting
      MEDARS GmbH, Berlin,  Germany; Recruiting
      Facharzt für Innere Medizin, Berlin,  Germany; Recruiting
      Dr. med. Reinhard Hüting, Minden,  Germany; Recruiting
      Pneumologisches Forschungsinstitut GmbH am Krankenhaus, Hamburg,  Germany; Recruiting
      1. Medizinisches Klinikum, Mainz,  Germany; Not yet recruiting
      Arzt für Lungen- und, Berlin,  Germany; Recruiting
      Arzt für Innere Medizin, Lungen- und, Bonn,  Germany; Not yet recruiting
Germany, -
      DFS-Verwaltung, Köln,  -,  Germany; Recruiting
      ClinPharm Internat. GmbH & Co. KG, Görlitz,  -,  Germany; Recruiting
      IFG - Institut für Gesundheitsförderung GmbH, Rüdersdorf,  -,  Germany; Recruiting
      Fachärztin für Allgemeinmedizin, Frankfurt/Main,  -,  Germany; Recruiting
      Inamed Research GmbH & Co. KG, Gauting,  -,  Germany; Recruiting
      Facharzt für Lungen- und, München,  -,  Germany; Recruiting
      Facharzt für Lungen- und, Fürth,  -,  Germany; Recruiting
Italy
      A. O. Universitaria di Ferrara - Arcispedale S. Anna, Ferrara,  Italy; Recruiting
      Università degli Studi di Genova, Genova,  Italy; Recruiting
      A.O. S. Martino e Cliniche Universitarie di Genova, Genova,  Italy; Recruiting
      A.O. Pisana, Pisa,  Italy; Recruiting
Netherlands
      Ziekenhuisgroep Twente, Hengelo,  Netherlands; Recruiting
      Ziekenhuisgroep Twent, Almelo,  Netherlands; Recruiting
      Medisch Centrum Leeuwarden, Leeuwarden,  Netherlands; Recruiting
      Atrium medisch centrum, HEERLEN,  Netherlands; Recruiting
      Maxima Medisch Centrum, VELDHOVEN,  Netherlands; Recruiting
      Afdeling longziekten, SNEEK,  Netherlands; Recruiting
      Amphia ziekenhuis, Breda,  Netherlands; Recruiting
South Africa
      Vergelegen Medi-Clinic, Somerset West,  South Africa; Recruiting
      Christiaan Barnard Memorial Hospital, Cape Town,  South Africa; Recruiting
      Medinel Clinical Trial Centre, Paarl,  South Africa; Recruiting
      Durban Lung Centre, Durban,  South Africa; Recruiting
      St. Augustine Hospital, Durban,  South Africa; Recruiting
      QdotPharma, George,  South Africa; Recruiting
      Kloof CRC, Pretoria,  South Africa; Recruiting
      Tiervlei Trial Centre, Bellville,  South Africa; Recruiting
      UCT Lung Institute, Cape Town,  South Africa; Recruiting

Study chairs or principal investigators

Peter Schmidt, Dr.,  Study Chair,  Boehringer Ingelheim Pharmaceuticals   

Study ID Numbers:  205.301
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152984
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices; Denmark: Danish Medicines Agency; Canada: Health Canada; Belgium: Ministry of Social Affairs, Public Health and the Environment; South Africa: Medicines Control Council; Italy: Ministry of Health; Netherlands: Medical Ethics Review Committee (METC); France: National Consultative Ethics Committee for Health and Life Sciences
ClinicalTrials.gov processed this record on 2005-09-13