An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

July 10, 2013 updated by: Boehringer Ingelheim

A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 Mcg (2 Actuations of 2.5 Mcg) and 10 Mcg (2 Actuations of 5 Mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler® as Add-on Therapy in Patients With Severe Persistent Asthma

The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

115

Phase

  • Phase 2

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

  • Denmark
      • Aalborg, Denmark
        • Boehringer Ingelheim Investigational Site
      • Aarhus C, Denmark
        • Boehringer Ingelheim Investigational Site
      • Hvidovre, Denmark
        • Boehringer Ingelheim Investigational Site
      • K?benhavn NV, Denmark
        • Boehringer Ingelheim Investigational Site
      • Odense C, Denmark
        • Boehringer Ingelheim Investigational Site
  • Germany
      • Gelnhausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Gro?hansdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Rudersdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Wiesbaden, Germany
        • Boehringer Ingelheim Investigational Site
      • Wiesloch, Germany
        • Boehringer Ingelheim Investigational Site
  • Netherlands
      • Breda, Netherlands
        • lokatie Langendijk
      • Eindhoven, Netherlands
        • Polikliniek longziekten
      • Groningen, Netherlands
        • Polikliniek longziekten
      • Heerlen, Netherlands
        • Polikliniek longziekten
      • Hengelo, Netherlands
        • Polikliniek longziekten
      • Zutphen, Netherlands
        • lokatie het Spittaal

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Outpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (GINA step 4), smoking history < 10 pack years and >= 1 year smoking cessation; Patients must be symptomatic

Exclusion Criteria:

Patients

  • with a recent history (i.e., six months or less) of myocardial infarction,
  • who have been hospitalized for heart failure (NYHA class III or IV) within the past year,
  • with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year,
  • with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years,
  • who have undergone thoracotomy with pulmonary resection,
  • with moderate to severe renal impairment (creatinine clearance = 50 mL/min)

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
The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period

Secondary Outcome Measures

Outcome Measure
FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc.

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

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.

General Publications

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, 2006

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (Estimate)

August 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.341

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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