NCT02172521

Brief Summary

  • Primary objective of this observational study was to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of life and physical functioning in patients with chronic obstructive pulmonary disease (COPD) and demonstrated hyperinflation.
  • Secondary objective was 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
1,536

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
7.7 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

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 (3)

  • Change from baseline for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score

    At baseline (visit 1) and after 4 weeks (visit 2)

  • Change from baseline for assessment of the health-related EQ-5D questionnaire linear rating scale

    At baseline (visit 1) and after 4 weeks (visit 2)

  • Change from baseline for assessment of physical functioning in every day life (PF-10)

    At baseline (visit 1) and after 4 weeks (visit 2)

Study Arms (1)

COPD and proven hyperinflation

Patients with COPD and proven hyperinflation receiving tiotropium bromide 18 microgram

Drug: Tiotropium bromide

Interventions

Tiotropium bromideDRUG

Tiotropium bromide18 micrograms by oral inhalation (1 x daily) with the HandiHaler®

Also known as: Spiriva®
COPD and proven hyperinflation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men with diagnosis of chronic obstructive pulmonary disease (COPD) with a thoracic gas volume (TGV) \> = 120% as measured by body plethysmography
  • Only patients who have not yet been treated with Spiriva® 18 micrograms can be included in the study.

You may not qualify if:

  • Patients who presenting the general and specific contraindications mentioned in the Patient Information and Prescribing 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

January 1, 2006

Primary Completion

October 1, 2006

Last Updated

June 24, 2014

Record last verified: 2014-06