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Clinical Trials/EUCTR2009-015713-51-LT
EUCTR2009-015713-51-LT
Active, not recruiting
Not Applicable

A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler®. - TIOSPIR

Boehringer Ingelheim RCV GmbH & Co KG0 sites16,800 target enrollmentMarch 18, 2010
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ConditionsChronic obstructive pulmonary disease (COPD)MedDRA version: 12.1Level: LLTClassification code 10009033Term: <Manually entered code. Term in E.1.1>
DrugsSpiriva Respimat 2.5 microgram, solution for inhalationSPIRIVA 18 microgram, inhalation powder, hard capsule

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic obstructive pulmonary disease (COPD)
Sponsor
Boehringer Ingelheim RCV GmbH & Co KG
Enrollment
16800
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 18, 2010
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. All patients must sign an informed consent consistent with ICH\-GCP guidelines
  • •prior to participation in the trial, includes medication washout and restrictions.
  • •2\. Male or female patients aged 40 years of age or over
  • •3\. Patients must be current or ex\-smokers with a smoking history of \=10 pack\-
  • •years. (Patients who have never smoked cigarettes must be excluded)
  • •4\. All patients must have a diagnosis of COPD and must meet the following
  • •Relatively stable airway obstruction with a post\-bronchodilator FEV1 \=70% of
  • •predicted normal and post\-bronchodilator FEV1 / FVC \=70%
  • •5\. Patients must be able to inhale from the HandiHaler® and the Respimat®
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •1\. Significant diseases other than COPD.
  • •2\. Patients with a recent history (i.e., six months or less) of myocardial infarction.
  • •3\. Patients with any unstable or life\-threatening cardiac arrhythmia requiring
  • •intervention or change in drug therapy during the last year.
  • •4\. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or
  • •IV) during the past year.
  • •5\. Known active tuberculosis.
  • •6\. Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung
  • •disease, or pulmonary thromboembolic disease
  • •7\. A history of thoracotomy with pulmonary resection.

Outcomes

Primary Outcomes

Not specified

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