NCT02172495

Brief Summary

Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,700

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

June 1, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
10.7 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

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

June 20, 2014

Last Update Submit

August 29, 2018

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (6)

  • Change from baseline in breathlessness when walking/climbing stairs

    Baseline, after 4 weeks

  • Change from baseline in breathlessness on physical exercise

    Baseline, after 4 weeks

  • Change from baseline in breathlessness during everyday activities

    Baseline, after 4 weeks

  • Change from baseline in breathlessness during housework

    Baseline, after 4 weeks

  • Change from baseline in overall severity of the clinical picture

    Baseline, after 4 weeks

  • Occurrence of Adverse Events

    4 weeks

Study Arms (1)

Symptoms of COPD

Patients with symptoms of COPD receiving Tiotropium bromide 18 micrograms

Drug: Tiotropium bromide

Interventions

Tiotropium bromideDRUG

Tiotropium bromide 18 micrograms

Also known as: Spiriva®
Symptoms of COPD

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged at least 40 years with the symptoms of Chronic Obstructive Pulmonary Disease

You may not qualify if:

  • Patients with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

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

June 1, 2002

Primary Completion

October 1, 2003

Last Updated

August 31, 2018

Record last verified: 2018-08