NCT02172547

Brief Summary

Post marketing Surveillance to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking during treatment and to obtain safety data regarding adverse events.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10,821

participants targeted

Target at P75+ for all trials

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, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

June 20, 2014

Last Update Submit

June 20, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Changes in health related quality of life

    6 weeks

Secondary Outcomes (1)

  • Occurrence of Adverse events

    6 weeks

Study Arms (1)

COPD patients who stopped smoking during treatment

Drug: Spiriva

Interventions

SpirivaDRUG
COPD patients who stopped smoking during treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General Practioner

You may qualify if:

  • Patients with COPD
  • Smoker at start

You may not qualify if:

  • Patients presenting with any general and specific contraindications listed in the Patient Information Leaflet ('Gebrauchsinformation') and the Basic Product Information('Fachinformation')

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Design

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

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 24, 2014

Study Start

April 1, 2006

Primary Completion

January 1, 2007

Last Updated

June 24, 2014

Record last verified: 2014-06