Brief Summary

The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.

Trial Health

On Track

Trial Health Score

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

Enrollment

754

participants targeted

Target at P75+ for all trials

Geographic Reach

1 country

73 active sites

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

April 1, 2007

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed

21 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

December 24, 2009

Completed

Last Updated

February 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 24, 2008

Results QC Date

June 30, 2009

Last Update Submit

January 13, 2016

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Secondary Outcomes (5)

Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Efficacy by Patient
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Tolerability by Patient
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Efficacy by Physician
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Tolerability by Physician
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Interventions

TiotropiumDRUG

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

primary care

You may qualify if:

Patients with suspected chronic obstructive pulmonary disease (COPD)
or more positive answers in COPD questionnaire
Age over 40 years

You may not qualify if:

Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
Patient treated with Spiriva in the past year
Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance\<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics

Contact the study team to confirm eligibility.