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Dyspnea in Patients With Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT00611182
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : November 18, 2013
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

Brief Summary:

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 or disease
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.


Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dyspnea in Patients With Pulmonary Fibrosis
Study Start Date : January 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Patients with Pulmonary Fibrosis



Primary Outcome Measures :
  1. Dyspnea [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Functional status [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00611182     History of Changes
Other Study ID Numbers: H5476-31357-01
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013

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

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