Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD

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)

Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Tiotropium; Device: HandiHaler; Device: Respimat SMI

• Study Type: Interventional
• Enrollment: 131
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 2P4
      • Montreal Chest Institute - McGill University Health Centre
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Division of Pulmonary and Critical Care Medicine
  • California
    • San Diego, California, United States, 92120
      • Boehringer Ingelheim Investigational Site
    • San Jose, California, United States, 95128
      • San Jose Clinical Research
    • Stockton, California, United States, 95207
      • Boehringer Ingelheim Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80206-2762
      • National Jewish Medical and Research Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • LSU MC-Sheveport
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minisota Lung Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Washington
    • Tacoma, Washington, United States, 98405
      • Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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.
• Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.
• Patients had to be able to perform technically acceptable pulmonary function tests and peak expiratory flow rate (PEFR) measurements, and had to be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol.
• Patients had to be able to inhale medication in a competent manner from the Respimat inhaler, the HandiHaler and from a metered dose inhaler (MDI).

Exclusion criteria:

• 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.
• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
• Patients with known narrow-angle glaucoma.
• Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥600 mm3.
• Further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Trough FEV1 response determined at the end of each 4-week period of randomised treatment.	at the end of each 4-week period

Secondary Outcome Measures

Outcome Measure	Time Frame
Tiotropium plasma concentration data and urinary excretion data	at the end of each 4-week period
Trough forced vital capacity (FVC) response	after 4 weeks
Peak response (FEV1 and FVC)	within 3 hours after first dose, after 4 weeks
FEV1 AUC 0-12h and FVC AUC 0-12h response	after 4 weeks
FEV1 AUC 0-3h and FVC AUC 0-3h response	after the first dose, after 4 weeks
Individual FEV1and FVC measurements	during study course of 28 weeks
pre-dose morning and evening peak expiratory flow rate (PEFR)	during study course of 28 weeks
Number of occasions of rescue therapy used	during study course of 28 weeks
Median time to onset of therapeutic response after first dose (FEV1)	after first dose and after 4 weeks
Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks	up to 28 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim BV/Alkmaar

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2002
• Primary Completion (Actual): April 29, 2004
• Study Completion (Actual): April 29, 2004

Study Registration Dates

• First Submitted: October 14, 2005
• First Submitted That Met QC Criteria: October 14, 2005
• First Posted (Estimated): October 17, 2005

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 205.249