NCT02176564

Brief Summary

A pharmaco-epidemiological, observational study that aimed at assessing in a prospective manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD) patients treated with inhaled bronchodilators

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,639

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, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2000

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
Last Updated

July 18, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

June 26, 2014

Last Update Submit

July 17, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Assessment of health-related quality of life (Short-Form Health Survey)

    4 months

Study Arms (1)

Chronic obstructive pulmonary disease

Patients with COPD treated with inhaled bronchodilators

Drug: inhaled bronchodilator

Interventions

inhaled bronchodilatorDRUG
Chronic obstructive pulmonary disease

Eligibility Criteria

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

Patients with COPD

You may qualify if:

  • Diagnosis of COPD confirmed by Pulmonary Function Test (PFTs)
  • Recent treatment with a free or fixed association of inhaled bronchodilators

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

Study Design

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

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 27, 2014

Study Start

June 1, 1999

Primary Completion

October 1, 2000

Last Updated

July 18, 2014

Record last verified: 2014-06