NCT00087906

Brief Summary

To test a conceptual model of how disability develops in chronic obstructive pulmonary disease (COPD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,589

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than 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

July 1, 2004

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

4.8 years

First QC Date

July 15, 2004

Last Update Submit

December 22, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • COPD Disability

    Observational self-reported impairment in valued life activities.

    10 years

Eligibility Criteria

AgeUp to 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

We recruited persons with COPD for what we came to term the "FLOW study." The original project was funded to complete two interviews and a single research clinic evaluation. In addition to completing this original program of work successfully, we also carried out follow-up research clinic visits for 667 subjects. These supplemental examinations were made possible through research funding support from the Flight Attendants Medical Research Foundation (FAMRI).

You may qualify if:

  • COPD diagnosis and
  • Medication use for cases

You may not qualify if:

  • \. Withdrew from Kaiser Plan prior to baseline contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Paul Blanc, MD

    University of California at San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2004

First Posted

July 19, 2004

Study Start

July 1, 2004

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 24, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share