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

November 30, 2023 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
Time Frame: at the end of each 4-week period
at the end of each 4-week period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Tiotropium plasma concentration data and urinary excretion data
Time Frame: at the end of each 4-week period
at the end of each 4-week period
Trough forced vital capacity (FVC) response
Time Frame: after 4 weeks
after 4 weeks
Peak response (FEV1 and FVC)
Time Frame: within 3 hours after first dose, after 4 weeks
within 3 hours after first dose, after 4 weeks
FEV1 AUC 0-12h and FVC AUC 0-12h response
Time Frame: after 4 weeks
after 4 weeks
FEV1 AUC 0-3h and FVC AUC 0-3h response
Time Frame: after the first dose, after 4 weeks
after the first dose, after 4 weeks
Individual FEV1and FVC measurements
Time Frame: during study course of 28 weeks
during study course of 28 weeks
pre-dose morning and evening peak expiratory flow rate (PEFR)
Time Frame: during study course of 28 weeks
during study course of 28 weeks
Number of occasions of rescue therapy used
Time Frame: during study course of 28 weeks
during study course of 28 weeks
Median time to onset of therapeutic response after first dose (FEV1)
Time Frame: after first dose and after 4 weeks
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
Time Frame: up to 28 weeks
up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim BV/Alkmaar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2005

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2005

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205.249

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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