Clinical trial NCT00168844: Tiotropium / Respimat One-Year Study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 983
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: To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.



Primary outcomes:
measure: Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)
timeFrame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
measure: Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)
timeFrame: Week 48
measure: TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)
timeFrame: Week 48
measure: COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)
timeFrame: 48 weeks
Secondary outcomes:
measure: Change From Baseline in Heart Rate
timeFrame: Baseline to Week 40 pre-dose
measure: Change From Baseline in PR Interval
timeFrame: Baseline to Week 40 pre-dose
measure: Change From Baseline in QRS Interval
timeFrame: Baseline to Week 40 pre-dose
measure: Change From Baseline in QT Interval
timeFrame: Baseline to Week 40 pre-dose
measure: Change From Baseline in QT Interval (Bazett)
timeFrame: Baseline to Week 40 pre-dose
measure: Change From Baseline in QT Interval (Fridericia)
timeFrame: Baseline to Week 40 pre-dose
measure: Change From Baseline in Heart Rate
timeFrame: Baseline to Week 40
measure: Change From Baseline in Supraventricular Premature Beat (SVPB) Total
timeFrame: Baseline to Week 40
measure: Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events
timeFrame: Baseline to Week 40
measure: Change From Baseline in SVPB Pairs
timeFrame: Baseline to Week 40
measure: Change From Baseline in Ventricular Premature Beat (VPB) Total
timeFrame: Baseline to Week 40
measure: Change From Baseline in VPB Run Events
timeFrame: Baseline to Week 40
measure: Change From Baseline in VPB Pairs
timeFrame: Baseline to Week 40
measure: Change From Baseline in Haematocrit, Packed Cell Volume (PCV)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Haemoglobin
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Red Blood Cell Count
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in White Blood Cell Count
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Platelets
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Neutrophils
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Eosinophils
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Basophils
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Lymphocytes
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Monocytes
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Neutrophils (Absolute)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Lymphocytes (Absolute)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Eosinophils (Absolute)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Basophils (Absolute)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Monocytes (Absolute)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Calcium
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Phosphate
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Alkaline Phosphatase
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Lactic Dehydrogenase (LDH)
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Glucose
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Urea
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Blood Urea Nitrogen
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Creatinine
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Bilirubin, Total
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Uric Acid
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Protein, Total
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Albumin
timeFrame: Baseline to Week 48 or at premature discontinuation if before Week 48
measure: Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks
timeFrame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
measure: Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks
timeFrame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
measure: Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks
timeFrame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
measure: Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks
timeFrame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
measure: Weekly Mean Morning Pre-dose PEFRs
timeFrame: Weeks 2, 8, 16, 24, 32, 40, 48
measure: Weekly Mean Evening PEFRs
timeFrame: Weeks 2, 8, 16, 24, 32, 40, 48
measure: Weekly Mean Number of Puffs of Rescue Medication Per Day
timeFrame: Weeks 2, 8, 16, 24, 32, 40, 48
measure: Mahler TDI Scores
timeFrame: Week 48
measure: Saint George's Respiratory Questionnaire (SGRQ) Scores
timeFrame: Week 48
measure: COPD Symptoms Scores
timeFrame: Week 48
measure: PGE Scores
timeFrame: Week 48
measure: PGR Score
timeFrame: Week 48
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Pismo Beach
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Fort Collins
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: Minneapolis
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Minnesota
city: Larchmont
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Raleigh
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Chattanooga
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Tennessee
city: Harker Heights
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Fredericksburg
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Harrisonburg
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Toorak Gardens
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: South Australia
city: Woodville
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: Victoria
city: Frankston
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: Victoria
city: Perth
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: Western Australia
city: Antwerpen
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Genk
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Wavre
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Edmonton
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Alberta
city: Halifax
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Courtice
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: Angers
country: France
facility: Boehringer Ingelheim Investigational Site
city: Beuvry
country: France
facility: Boehringer Ingelheim Investigational Site
city: Cambrai
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: Boehringer Ingelheim Investigational Site
city: Metz cedex 01
country: France
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Darmstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kassel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rüdersdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Heraklion
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Larissa
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Maroussi, Athens
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Melissia-Athens
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Dordrecht
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Harderwijk
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Zutphen
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: Boehringer Ingelheim Investigational Site
city: Trondheim
country: Norway
facility: Boehringer Ingelheim Investigational Site
city: Ålesund
country: Norway
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Alicante
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Vic (Barcelona)
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Motala
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Skövde
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Varberg
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: Boehringer Ingelheim Investigational Site
city: Bursa
country: Turkey
facility: Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
city: Bristol
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
city: Nottingham
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
city: Swansea
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
city: Torquay
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
citation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
citation: Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.
citation: Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat(R) Soft Mist Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245-51. doi: 10.2147/COPD.S16094. Epub 2011 Apr 26.