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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152984
• Other study ID #: 205.301
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: December 27, 2017
• Start date: December 2004
• Est. completion date: April 2006

Study information

• Verified date: December 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium inhalation capsules

• Placebo inhalation capsules

Locations

Country	Name	City	State
Belgium	CHU Sart Tilman	Angleur
Belgium	A.Z. VUB	Brussel
Belgium	Boehringer Ingelheim Investigational Site	Genk
Belgium	Boehringer Ingelheim Investigational Site	Hasselt
Belgium	St. Elisabethziekenhuis	Herentals
Belgium	Clinique Reine Astrid	Malmedy
Belgium	Sint-Elisabethziekenhuis	Turnhout
Canada	Department of Medicine, Health Sciences Centre	Hamilton	Ontario
Canada	Boehringer Ingelheim Investigational Site	Mississauga	Ontario
Canada	Centre de Recherche Clinique -CUSE	Sherbrooke	Quebec
Canada	Hopital Laval	Ste-Foy	Quebec
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Department of Respiratory Medicine	Toronto	Ontario
Canada	Respiratory Research Lab	Toronto	Ontario
Canada	VGH Research Pavillion	Vancouver	British Columbia
Canada	BG 034, Room C2027	Winnipeg	Manitoba
Denmark	Lungemedicinsk Forskning 2B	Aarhus
Denmark	Lungemedicinsk afdeling Y	Hellerup
Denmark	Medicinsk afdeling B0642	Hiller?d
Denmark	Lungemedicinsk Klinik	Hvidovre
Denmark	H:S Bispebjerg Hospital	K?benhavn NV
Denmark	Lungemedicinsk Forskning	Odense C
France	Hopital d'Annecy	Annecy
France	Hopital Prive Antony	Antony cedex
France	Boehringer Ingelheim Investigational Site	Chamalieres
France	Hopital Gabriel Montpied	Clermont Ferrand cedex 1
France	Hopital Ambroise Pare	Marseille
France	Hopital Notre Dame de Bon Secours	Metz cedex 1
France	Boehringer Ingelheim Investigational Site	Montpellier
France	Hopital Arnaud de Villeneuve	Montpellier
France	Boehringer Ingelheim Investigational Site	Nantes
France	Centre Medical Erdre St Augustin	Nantes
France	Boehringer Ingelheim Investigational Site	Nice
France	Hopital Maison blanche	Reims cedex
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	MEDARS GmbH	Berlin
Germany	Boehringer Ingelheim Investigational Site	Bonn
Germany	Boehringer Ingelheim Investigational Site	Frankfurt/Main
Germany	Boehringer Ingelheim Investigational Site	Furth
Germany	Inamed Research GmbH & Co. KG	Gauting
Germany	Boehringer Ingelheim Investigational Site	Gelnhausen
Germany	ClinPharm Internat. GmbH & Co. KG	Gorlitz
Germany	Pneumologisches Forschungsinstitut GmbH am Krankenhaus	Hamburg
Germany	Med. Einrichtung der Universitat zu Koln	Koln
Germany	Boehringer Ingelheim Investigational Site	Minden
Germany	Boehringer Ingelheim Investigational Site	Munchen
Germany	Boehringer Ingelheim Investigational Site	Rudersdorf
Italy	A. O. Universitaria di Ferrara - Arcispedale S. Anna	Ferrara
Italy	A.O. S. Martino e Cliniche Universitarie di Genova	Genova
Italy	Universita di Genova	Genova
Italy	A.O. Pisana	Pisa
Netherlands	Ziekenhuisgroep Twent	Almelo
Netherlands	Amphia ziekenhuis	Breda
Netherlands	Atrium medisch centrum	Heerlen
Netherlands	Ziekenhuigroep Twente	Hengelo
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Antonius Ziekenhuis	Sneek
Netherlands	Maxima Medisch Centrum	Velthoven
South Africa	Boehringer Ingelheim Investigational Site	Bellville
South Africa	Boehringer Ingelheim Investigational Site	Cape Town
South Africa	Boehringer Ingelheim Investigational Site	Cape Town
South Africa	Boehringer Ingelheim Investigational Site	Durban
South Africa	Boehringer Ingelheim Investigational Site	George
South Africa	Boehringer Ingelheim Investigational Site	Paarl
South Africa	Boehringer Ingelheim Investigational Site	Pretoria
South Africa	Boehringer Ingelheim Investigational Site	Somerset West

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose)		after 12 weeks of treatment
Secondary	Forced vital capacity (FVC)		12 weeks
Secondary	Peak expiratory flow rate (PEFR)		12 weeks
Secondary	Use of rescue medication		12 weeks
Secondary	AUC0-6hFEV1		after first dose on Day 1 and after 4 weeks of treatment
Secondary	Change in trough FEV1 (i.e. trough response) from baseline.		after 4 and 12 weeks of treatment
Secondary	Change in peak FEV1 from baseline (=peak response) after first dose		after 4 and 12 weeks of treatment
Secondary	AUC0-6hFVC defined in the same way as for FEV1.		Day 1, week 4
Secondary	Trough FVC defined in the same way as for FEV1.		Day 1, week 4
Secondary	Peak FVC defined in the same way as for FEV1		Day 1, week 4
Secondary	Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement).		12 weeks
Secondary	Weekly average number of puffs of rescue medication used		12 weeks
Secondary	Occurrence of adverse events		12 weeks
Secondary	Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry		12 weeks
Secondary	Change from baseline in Physical examination		12 weeks

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