Tiotropium / Respimat One-Year Study

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168844
• Other study ID #: 205.254
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 15, 2014
• Start date: January 2003

Study information

• Verified date: September 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 983
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tiotropium Inhalation Solution

Other:
• Placebo

Locations

Country	Name	City	State
Australia	Boehringer Ingelheim Investigational Site	Clayton	Victoria
Australia	Boehringer Ingelheim Investigational Site	Frankston	Victoria
Australia	Boehringer Ingelheim Investigational Site	Perth	Western Australia
Australia	Boehringer Ingelheim Investigational Site	Toorak Gardens	South Australia
Australia	Boehringer Ingelheim Investigational Site	Woodville	South Australia
Belgium	Boehringer Ingelheim Investigational Site	Antwerpen
Belgium	Boehringer Ingelheim Investigational Site	Brussel
Belgium	Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	Boehringer Ingelheim Investigational Site	Genk
Belgium	Boehringer Ingelheim Investigational Site	Gent
Belgium	Boehringer Ingelheim Investigational Site	Liège
Belgium	Boehringer Ingelheim Investigational Site	Wavre
Canada	Boehringer Ingelheim Investigational Site	Courtice	Ontario
Canada	Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia
Canada	Boehringer Ingelheim Investigational Site	Mississauga	Ontario
Canada	Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	Boehringer Ingelheim Investigational Site	Sainte-Foy	Quebec
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
France	Boehringer Ingelheim Investigational Site	Angers
France	Boehringer Ingelheim Investigational Site	Beuvry
France	Boehringer Ingelheim Investigational Site	Cambrai
France	Boehringer Ingelheim Investigational Site	Lille
France	Boehringer Ingelheim Investigational Site	Metz cedex 01
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Darmstadt
Germany	Boehringer Ingelheim Investigational Site	Gelnhausen
Germany	Boehringer Ingelheim Investigational Site	Kassel
Germany	Boehringer Ingelheim Investigational Site	Rüdersdorf
Greece	Boehringer Ingelheim Investigational Site	Athens
Greece	Boehringer Ingelheim Investigational Site	Heraklion
Greece	Boehringer Ingelheim Investigational Site	Larissa
Greece	Boehringer Ingelheim Investigational Site	Maroussi, Athens
Greece	Boehringer Ingelheim Investigational Site	Melissia-Athens
Netherlands	Boehringer Ingelheim Investigational Site	Breda
Netherlands	Boehringer Ingelheim Investigational Site	Dordrecht
Netherlands	Boehringer Ingelheim Investigational Site	Groningen
Netherlands	Boehringer Ingelheim Investigational Site	Harderwijk
Netherlands	Boehringer Ingelheim Investigational Site	Heerlen
Netherlands	Boehringer Ingelheim Investigational Site	Zutphen
Norway	Boehringer Ingelheim Investigational Site	Ålesund
Norway	Boehringer Ingelheim Investigational Site	Oslo
Norway	Boehringer Ingelheim Investigational Site	Trondheim
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Spain	Boehringer Ingelheim Investigational Site	Alicante
Spain	Boehringer Ingelheim Investigational Site	Las Palmas de Gran Canaria
Spain	Boehringer Ingelheim Investigational Site	Madrid
Spain	Boehringer Ingelheim Investigational Site	Vic (Barcelona)
Sweden	Boehringer Ingelheim Investigational Site	Motala
Sweden	Boehringer Ingelheim Investigational Site	Skövde
Sweden	Boehringer Ingelheim Investigational Site	Uppsala
Sweden	Boehringer Ingelheim Investigational Site	Varberg
Turkey	Boehringer Ingelheim Investigational Site	Ankara
Turkey	Boehringer Ingelheim Investigational Site	Bursa
Turkey	Boehringer Ingelheim Investigational Site	Istanbul
United Kingdom	Boehringer Ingelheim Investigational Site	Birmingham
United Kingdom	Boehringer Ingelheim Investigational Site	Bristol
United Kingdom	Boehringer Ingelheim Investigational Site	Nottingham
United Kingdom	Boehringer Ingelheim Investigational Site	Sheffield
United Kingdom	Boehringer Ingelheim Investigational Site	Swansea
United Kingdom	Boehringer Ingelheim Investigational Site	Torquay
United States	Boehringer Ingelheim Investigational Site	Chattanooga	Tennessee
United States	Boehringer Ingelheim Investigational Site	Fort Collins	Colorado
United States	Boehringer Ingelheim Investigational Site	Fredericksburg	Virginia
United States	Boehringer Ingelheim Investigational Site	Harker Heights	Texas
United States	Boehringer Ingelheim Investigational Site	Harrisonburg	Virginia
United States	Boehringer Ingelheim Investigational Site	Houston	Texas
United States	Boehringer Ingelheim Investigational Site	Larchmont	New York
United States	Boehringer Ingelheim Investigational Site	Los Angeles	California
United States	Boehringer Ingelheim Investigational Site	Minneapolis	Minnesota
United States	Boehringer Ingelheim Investigational Site	Pismo Beach	California
United States	Boehringer Ingelheim Investigational Site	Raleigh	North Carolina
United States	Boehringer Ingelheim Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Greece,  Netherlands,  Norway,  Russian Federation,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)	Trough Forced Expiratory Volume in 1 second (FEV1)	10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication	No
Primary	Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)	Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0	Week 48	No
Primary	TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)	Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9; For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined.	Week 48	No
Primary	COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)	Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year.; For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.	48 weeks	No
Secondary	Change From Baseline in Heart Rate	Week 40 pre-dose - baseline	Baseline to Week 40 pre-dose	No
Secondary	Change From Baseline in PR Interval		Baseline to Week 40 pre-dose	No
Secondary	Change From Baseline in QRS Interval	Week 40 pre-dose - baseline	Baseline to Week 40 pre-dose	No
Secondary	Change From Baseline in QT Interval	Week 40 pre-dose - baseline	Baseline to Week 40 pre-dose	No
Secondary	Change From Baseline in QT Interval (Bazett)	Week 40 pre-dose - baseline	Baseline to Week 40 pre-dose	No
Secondary	Change From Baseline in QT Interval (Fridericia)	Week 40 pre-dose - baseline	Baseline to Week 40 pre-dose	No
Secondary	Change From Baseline in Heart Rate	Week 40 - baseline	Baseline to Week 40	No
Secondary	Change From Baseline in Supraventricular Premature Beat (SVPB) Total	Week 40 - baseline	Baseline to Week 40	No
Secondary	Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events	Week 40 - baseline	Baseline to Week 40	No
Secondary	Change From Baseline in SVPB Pairs	Week 40 - baseline	Baseline to Week 40	No
Secondary	Change From Baseline in Ventricular Premature Beat (VPB) Total	Week 40 - baseline	Baseline to Week 40	No
Secondary	Change From Baseline in VPB Run Events	Week 40 - baseline	Baseline to Week 40	No
Secondary	Change From Baseline in VPB Pairs	Week 40 - baseline	Baseline to Week 40	No
Secondary	Change From Baseline in Haematocrit, Packed Cell Volume (PCV)	Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Haemoglobin	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Red Blood Cell Count	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in White Blood Cell Count	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Platelets	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Neutrophils	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Eosinophils	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Basophils	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Lymphocytes	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Monocytes	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Neutrophils (Absolute)	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Lymphocytes (Absolute)	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Eosinophils (Absolute)	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Basophils (Absolute)	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Monocytes (Absolute)	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Calcium	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Phosphate	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Alkaline Phosphatase	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Lactic Dehydrogenase (LDH)	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Glucose	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Urea	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Blood Urea Nitrogen	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Creatinine	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Bilirubin, Total	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Uric Acid	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Protein, Total	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Albumin	Week 48 - baseline	Baseline to Week 48 or at premature discontinuation if before Week 48	No
Secondary	Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks	Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.	10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication	No
Secondary	Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks	Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.	10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication	No
Secondary	Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks	FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.	10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication	No
Secondary	Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks	FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.	10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication	No
Secondary	Weekly Mean Morning Pre-dose PEFRs	Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.	Weeks 2, 8, 16, 24, 32, 40, 48	No
Secondary	Weekly Mean Evening PEFRs	Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.	Weeks 2, 8, 16, 24, 32, 40, 48	No
Secondary	Weekly Mean Number of Puffs of Rescue Medication Per Day	Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.	Weeks 2, 8, 16, 24, 32, 40, 48	No
Secondary	Mahler TDI Scores	Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.; Worst score = -3, best score = +3	Week 48	No
Secondary	Saint George's Respiratory Questionnaire (SGRQ) Scores	Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.; The means are adjusted for centre, smoking status at entry and baseline value.	Week 48	No
Secondary	COPD Symptoms Scores	COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe; The means are adjusted for centre, smoking status at entry and baseline value.	Week 48	No
Secondary	PGE Scores	Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1-2 = Poor, 3-4 = Fair, 5-6 = Good, 7-8 = Excellent; The means are adjusted for centre, smoking status at entry and baseline value.	Week 48	No
Secondary	PGR Score	Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse; The means are adjusted for centre, smoking status at entry and baseline value.	Week 48	No

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