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Clinical Trials/NCT02177318
NCT02177318CompletedNot Applicable

Drug Use Results Survey of Tiotropium Bromide

Boehringer Ingelheim1 site in 1 country3,588 target enrollmentStarted: April 2005Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,588
Locations
1
Primary Endpoint
Number of patients with adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with COPD

Exclusion Criteria

  • •There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice

Arms & Interventions

Patients with COPD

Intervention: Spiriva (tiotropium bromide) inhalation capsules (Drug)

Outcomes

Primary Outcomes

Number of patients with adverse events

Time Frame: Up to 4 weeks after start of treatment

Number of patients with adverse drug reactions

Time Frame: Up to 4 weeks after start of treatment

Number of patients with serious adverse events

Time Frame: Up to 4 weeks after start of treatment

Secondary Outcomes

  • Physician's overall judgement by medical interview into four grades: 1. Improved 2. No Change 3. Aggravated 4.Unassessable(Up to 4 weeks after start of treatment)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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