Dyspnea in Patients With Pulmonary Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Patients with Pulmonary Fibrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dyspnea	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional status	6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: 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

Publications and helpful links

Helpful Links

• UCSF Interstitial Lung Disease Program

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 28, 2008
• First Submitted That Met QC Criteria: February 7, 2008
• First Posted (Estimate): February 8, 2008

Study Record Updates

• Last Update Posted (Estimate): November 18, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: interstitial lung disease; dyspnea; shortness of breath; pulmonary fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Fibrosis; Pulmonary Fibrosis; Dyspnea
• Other Study ID Numbers: H5476-31357-01