Tiotropium / Respimat One-Year Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Tiotropium Inhalation Solution Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT) [ Time Frame: Baseline to Week 48 ]
Trough Forced Expiratory Volume in 1 second (FEV1)
Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) [ Time Frame: Week 48 ]
Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0
TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) [ Time Frame: Week 48 ]
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
COPD Exacerbation Rate, Safety Set (SS) [ Time Frame: 48 weeks ]
Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year

Secondary Outcome Measures:

Change From Baseline in Heart Rate [ Time Frame: Baseline to Week 40 pre-dose ]
Week 40 pre-dose - baseline
Change From Baseline in PR Interval [ Time Frame: Baseline to Week 40 pre-dose ]
Change From Baseline in QRS Interval [ Time Frame: Baseline to Week 40 pre-dose ]
Week 40 pre-dose - baseline
Change From Baseline in QT Interval [ Time Frame: Baseline to Week 40 pre-dose ]
Week 40 pre-dose - baseline
Change From Baseline in QT Interval (Bazett) [ Time Frame: Baseline to Week 40 pre-dose ]
Week 40 pre-dose - baseline
Change From Baseline in QT Interval (Fridericia) [ Time Frame: Baseline to Week 40 pre-dose ]
Week 40 pre-dose - baseline
Change From Baseline in Heart Rate [ Time Frame: Baseline to Week 40 ]
Week 40 - baseline
Change From Baseline in Supraventricular Premature Beat (SVPB) Total [ Time Frame: Baseline to Week 40 ]
Week 40 - baseline
Change From Baseline in SVPB Run Events [ Time Frame: Baseline to Week 40 ]
Week 40 - baseline
Change From Baseline in SVPB Pairs [ Time Frame: Baseline to Week 40 ]
Week 40 - baseline
Change From Baseline in Ventricular Premature Beat (VPB) Total [ Time Frame: Baseline to Week 40 ]
Week 40 - baseline
Change From Baseline in Ventricular Premature Beat (VPB) Run Events [ Time Frame: Baseline to Week 40 ]
Week 40 - baseline
Change From Baseline in VPB Pairs [ Time Frame: Baseline to Week 40 ]
Week 40 - baseline
Change From Baseline in Haematocrit, Packed Cell Volume (PCV) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Change From Baseline in Haemoglobin [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Red Blood Cell Count [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in White Blood Cell Count [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Platelets [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Neutrophils [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Eosinophils [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Basophils [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Lymphocytes [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Monocytes [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Neutrophils (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Eosinophils (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Basophils (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Lymphocytes (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Monocytes (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Calcium [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Phosphate [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Alkaline Phosphatase [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Lactic Dehyrogenase (LDH) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Glucose [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Urea [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Blood Urea Nitrogen [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Creatinine [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Bilirubin, Total [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Uric Acid [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Protein, Total [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline
Change From Baseline in Albumin [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
Week 48 - baseline

Enrollment:	1007
Study Start Date:	February 2003
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tiotropium Respimat 5mcg (Tio R5)	Drug: Tiotropium Inhalation Solution
Tiotropium Respimat 10mcg (Tio R10)	Drug: Tiotropium Inhalation Solution
Placebo	Other: Placebo

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168831

Show 78 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat® Soft Mist™ Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245-51. Epub 2011 Apr 26.

ClinicalTrials.gov Identifier:	NCT00168831 History of Changes
Other Study ID Numbers:	205.255
Study First Received:	September 12, 2005
Results First Received:	January 30, 2009
Last Updated:	May 14, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013