Clinical trial NCT00152984: Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 472
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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 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

Primary outcomes:
measure: AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose)
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 12 weeks
measure: Peak expiratory flow rate (PEFR)
timeFrame: 12 weeks
measure: Use of rescue medication
timeFrame: 12 weeks
measure: AUC0-6hFEV1
timeFrame: after first dose on Day 1 and after 4 weeks of treatment
measure: Change in trough FEV1 (i.e. trough response) from baseline.
timeFrame: after 4 and 12 weeks of treatment
measure: Change in peak FEV1 from baseline (=peak response) after first dose
timeFrame: after 4 and 12 weeks of treatment
measure: AUC0-6hFVC defined in the same way as for FEV1.
timeFrame: Day 1, week 4
measure: Trough FVC defined in the same way as for FEV1.
timeFrame: Day 1, week 4
measure: Peak FVC defined in the same way as for FEV1
timeFrame: Day 1, week 4
measure: Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement).
timeFrame: 12 weeks
measure: Weekly average number of puffs of rescue medication used
timeFrame: 12 weeks
measure: Occurrence of adverse events
timeFrame: 12 weeks
measure: Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry
timeFrame: 12 weeks
measure: Change from baseline in Physical examination
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Angleur
country: Belgium
facility: CHU Sart Tilman
city: Brussel
country: Belgium
facility: A.Z. VUB
city: Genk
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Hasselt
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Herentals
country: Belgium
facility: St. Elisabethziekenhuis
city: Malmedy
country: Belgium
facility: Clinique Reine Astrid
city: Turnhout
country: Belgium
facility: Sint-Elisabethziekenhuis
city: Vancouver
country: Canada
facility: VGH Research Pavillion
state: British Columbia
city: Winnipeg
country: Canada
facility: BG 034, Room C2027
state: Manitoba
city: Hamilton
country: Canada
facility: Department of Medicine, Health Sciences Centre
state: Ontario
city: Mississauga
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Respiratory Research Lab
state: Ontario
city: Toronto
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Department of Respiratory Medicine
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre de Recherche Clinique -CUSE
state: Quebec
city: Ste-Foy
country: Canada
facility: Hopital Laval
state: Quebec
city: Aarhus
country: Denmark
facility: Lungemedicinsk Forskning 2B
city: Hellerup
country: Denmark
facility: Lungemedicinsk afdeling Y
city: Hiller?d
country: Denmark
facility: Medicinsk afdeling B0642
city: Hvidovre
country: Denmark
facility: Lungemedicinsk Klinik
city: K?benhavn NV
country: Denmark
facility: H:S Bispebjerg Hospital
city: Odense C
country: Denmark
facility: Lungemedicinsk Forskning
city: Annecy
country: France
facility: Hopital d'Annecy
city: Antony cedex
country: France
facility: Hopital Prive Antony
city: Chamalieres
country: France
facility: Boehringer Ingelheim Investigational Site
city: Clermont Ferrand cedex 1
country: France
facility: Hopital Gabriel Montpied
city: Marseille
country: France
facility: Hopital Ambroise Pare
city: Metz cedex 1
country: France
facility: Hopital Notre Dame de Bon Secours
city: Montpellier
country: France
facility: Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Nantes
country: France
facility: Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: Centre Medical Erdre St Augustin
city: Nice
country: France
facility: Boehringer Ingelheim Investigational Site
city: Reims cedex
country: France
facility: Hopital Maison blanche
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: MEDARS GmbH
city: Bonn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Furth
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gauting
country: Germany
facility: Inamed Research GmbH & Co. KG
city: Gelnhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gorlitz
country: Germany
facility: ClinPharm Internat. GmbH & Co. KG
city: Hamburg
country: Germany
facility: Pneumologisches Forschungsinstitut GmbH am Krankenhaus
city: Koln
country: Germany
facility: Med. Einrichtung der Universitat zu Koln
city: Minden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Munchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rudersdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: A. O. Universitaria di Ferrara - Arcispedale S. Anna
city: Genova
country: Italy
facility: A.O. S. Martino e Cliniche Universitarie di Genova
city: Genova
country: Italy
facility: Universita di Genova
city: Pisa
country: Italy
facility: A.O. Pisana
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twent
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Heerlen
country: Netherlands
facility: Atrium medisch centrum
city: Hengelo
country: Netherlands
facility: Ziekenhuigroep Twente
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Velthoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Bellville
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: George
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Paarl
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Somerset West
country: South Africa
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: B.I. Pharma GmbH & Co. KG
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: