Completed
Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
What is being tested
Data Collection
Who is being recruted
Chronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
Over 40 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: November 2002
Summary
Principal SponsorBoehringer Ingelheim
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 26, 2002
Actual date on which the first participant was enrolled.Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler
Official TitleEfficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Principal SponsorBoehringer Ingelheim
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
131 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive
Criteria
7 inclusion criteria required to participate
All patients had to sign an informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
All patients had to have a diagnosis of chronic obstructive pulmonary disease.
Patients had to have relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (FEV1) ≤ 60% of predicted normal and FEV1 ≤ 70% of forced vital capacity FVC (Visits 1 and 2).
Male or female patients 40 years of age or older.
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9 exclusion criteria prevent from participating
Patients with significant diseases other than chronic obstructive pulmonary disease (COPD) had to be excluded. A significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
Patients with a recent history (i.e., one year or less) of myocardial infarction.
Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
Suspended
Division of Pulmonary and Critical Care Medicine
Little Rock, United StatesOpen Division of Pulmonary and Critical Care Medicine in Google MapsSuspended
Boehringer Ingelheim Investigational Site
San Diego, United StatesSuspended
San Jose Clinical Research
San Jose, United StatesSuspended
Boehringer Ingelheim Investigational Site
Stockton, United StatesCompleted11 Study Centers