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

October 31, 2013 updated by: Boehringer Ingelheim

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover 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)

Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • 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

  • Belgium
      • Study chairs or principal investigators, Belgium
        • Boehringer Ingelheim Investigational Site
  • Netherlands
      • Study chairs or principal investigators, Netherlands
        • 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

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of COPD
  • FEV1 < 60% predicted
  • FEV1 < 70% of FVC
  • Smoking history of 10 pack-years

Exclusion Criteria:

  • Significant other disease than COPD
  • Recent history of MI (1 year or less)
  • Cardiac arrhythmia requiring drug therapy
  • History of asthma, allergic rhinitis or eosinophil count > 600 mm3
  • Symptomatic prostatic hypertrophy or bladder neck obstruction
  • Known narrow-angle glaucoma
  • Abnormal baseline hematology, blood chemistry or urinalysis
  • History of cancer within last 5 years
  • Life-threatening pulmonary obstruction
  • Cystic fibrosis or bronchiectasis
  • Tuberculosis
  • Pulmonary resection

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

Outcome Measure
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).

Secondary Outcome Measures

Outcome Measure
Time Frame
Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)
Time Frame: baseline until week 28
baseline until week 28
Peak response (FEV1 and FVC) to first dose
Time Frame: within 3 hours to first dose
within 3 hours to first dose
Peak response (FEV1 and FVC) after 4 weeks
Time Frame: within 3 hours after 4 weeks
within 3 hours after 4 weeks
FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks
Time Frame: after 4 weeks
after 4 weeks
FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks
Time Frame: after first dose and after 4 weeks
after first dose and after 4 weeks
Individual FEV1and FVC measurements at each time point
Time Frame: up to 28 weeks
up to 28 weeks
Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients
Time Frame: up to 28 weeks
up to 28 weeks
Number of occasions of rescue therapy used as required (p.r.n. salbutamol)
Time Frame: up to 28 weeks
up to 28 weeks
Median time to onset of therapeutic response after first dose
Time Frame: after 4 weeks
after 4 weeks
Number of patients with 15% response above baseline for each treatment at each timepoint after first dose
Time Frame: at week 4, 12, 20
at week 4, 12, 20
Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks
Time Frame: at week 8, 16, 24
at week 8, 16, 24

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim KG

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

August 1, 2002

Primary Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria

January 24, 2006

First Posted (Estimate)

January 25, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.250

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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