Dyspnea in Patients With Pulmonary Fibrosis

This study has been completed.
Sponsor:
Collaborators:
University of Chicago
American College of Chest Physicians
The John A. Hartford Foundation
Association of Specialty Physicians, Inc.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00611182
First received: January 28, 2008
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

This study has two aims:

  1. To determine the relationship of shortness of breath (dyspnea) to other conditions present in patients with pulmonary fibrosis.
  2. To define the relationship between shortness of breath and rate of functional decline in patients with pulmonary fibrosis.

Condition
Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dyspnea in Patients With Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Dyspnea [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional status [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with Pulmonary Fibrosis

Detailed Description:

Idiopathic Pulmonary Fibrosis is the most common form of chronic fibrosing lung disease seen by pulmonologists, with an estimated 128,000 cases in the United States alone. It is almost surely a disorder related to aging, with a median age at the time of diagnosis of approximately 65 years; IPF is almost unheard of under the age of 50. Dyspnea is common in patients with IPF, and is often the primary symptom of the disease. It is tightly linked to quality of life in IPF, suggesting that the experience of dyspnea has wide-ranging and clinically-significant consequences. Despite its importance, surprisingly little is known about the etiology or functional impact of dyspnea in this disease.

This research proposal focuses on defining the relationship of dyspnea to comorbidity and the rate of functional decline in patients with IPF

Aim 1: To determine the relationship of dyspnea to other conditions present in patients with IPF.

Dyspnea is a complex symptom, related to both mechanical and cognitive factors. The mechanisms of dyspnea in IPF remain unknown, but there are several likely contributors that are both IPF and non-IPF related. Although IPF is a chronic disease of the elderly, no one has investigated the relationship between common geriatric conditions and dyspnea. It is well established that the perception of dyspnea depends equally on factors that influence the intensity of the experience of breathlessness (such as thoracic restriction and weakness) and the distress which that intensity produces. Gender, ethnicity, anxiety, pain, and depression all may contribute to the distress caused by dyspnea (and therefore its intensity) in IPF.

Aim 2: To define the relationship between dyspnea and rate of functional decline in IPF.

Numerous studies have looked at predictors of survival in patients with IPF, and both baseline and change in dyspnea over time have been shown to be significantly associated. The prediction of future morbidity, however, is largely unstudied. Established markers of functional decline in geriatric patients include weight loss, decline in walking speed over 4 meters, and the onset of disability as defined by the ability to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). Dyspnea likely impacts patients' activity levels and/or motivation to stay active, and may contribute to worsening functional decline.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • 18 years of age and older with pulmonary fibrosis, and able to travel to University of California San Francisco for study visits

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611182

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
University of Chicago
American College of Chest Physicians
The John A. Hartford Foundation
Association of Specialty Physicians, Inc.
Investigators
Principal Investigator: Harold R. Collard, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00611182     History of Changes
Other Study ID Numbers: H5476-31357-01
Study First Received: January 28, 2008
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
dyspnea
pulmonary fibrosis
interstitial lung disease
shortness of breath

Additional relevant MeSH terms:
Dyspnea
Fibrosis
Pulmonary Fibrosis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Lung Diseases

ClinicalTrials.gov processed this record on July 28, 2014