NCT01145053

Brief Summary

To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 30, 2013

Completed
Last Updated

March 27, 2014

Status Verified

February 1, 2014

Enrollment Period

1.6 years

First QC Date

June 15, 2010

Results QC Date

December 18, 2012

Last Update Submit

February 27, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events (AEs)

    The number of patient with any AEs, patients with drug-related AEs

    Week 52

Secondary Outcomes (6)

  • Effectiveness

    Week 52

  • Forced Expiratory Volume in One Second (FEV1)

    Week 0 and Week 52

  • Cough Frequency

    Week 0 and Week 52

  • Amount of Sputum

    Week 0 and Week 52

  • Shortness of Breath

    Week 0 and Week 52

  • +1 more secondary outcomes

Study Arms (1)

Treatment

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

300

You may qualify if:

  • Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat.

You may not qualify if:

  • There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. Spiriva Respimat is contraindicated in patients with hypersensitivity to Tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in Package labelling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 16, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 27, 2014

Results First Posted

January 30, 2013

Record last verified: 2014-02