Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• ClinicalTrials.gov Identifier: NCT01874223
• Recruitment Status: Unknown
• First Posted: June 10, 2013
• Last Update Posted: June 10, 2013
• Sponsor: Stanford University
• Collaborator: Celgene Corporation
• Information provided by (Responsible Party): Glenn D. Rosen, Stanford University

Study Description

Brief Summary:

The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure the severity of cough, breathlessness, and changes in cough and disease-related quality of life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have been used in other types of disease, but have not all been tested and validated in patients with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related QOL questionnaire scores will correlate with physiologic markers of IPF severity and worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are important to assess the benefit of investigational drugs under development to treat patients with IPF.

Condition or disease
Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Detailed Description:

This study in patients with IPF will determine the validity, responsiveness, and reliability of two cough measures (the Leicester Cough Questionnaire (LCQ), as well as Visual Analogue Scales (VASs) for cough severity and distress; one dyspnea measure (the Baseline and Transition Dyspnea Index (BDI/TDI); and two health-related quality of life (HRQL) measures (the obstructive lung disease-specific Saint George's Respiratory Questionnaire (SGRQ) and the IPF-specific 'A Tool to Assess QOL in IPF' (ATAQ-IPF). Both the SGRQ and ATAQ include cough questions. Study participants will complete all questionnaires at baseline, 6, 12, and 18 months at the time of their usual clinic visits. Physiologic data will be collected at the same time of these visits including pulmonary function testing, exercise oxygen saturation, and changes in medications and health status. Changes in cough, dyspnea and QOL scores will be correlated with concurrent changes in physiologic markers of IPF severity. If a study participant has an acute worsening of their IPF, or undergoes lung transplantation, study questionnaires may be given at these additional timepoints when possible.

Study Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Study Start Date: June 2013
• Estimated Primary Completion Date: June 2015
• Estimated Study Completion Date: September 2015

Groups and Cohorts

Group/Cohort

IPF-diagnosed patients; A group of up to 40 patients with a diagnosis of mild to severe IPF per American Thoracic Society (ATS) guidelines, either with no cough at baseline to severe cough at baseline, will be followed for at least a one-time assessment and every six months for up to 18 months to establish validity, responsiveness, and reliability of cough, dyspnea, and QOL instruments in patients with IPF.

Outcome Measures

Primary Outcome Measures :

1. Correlation of LCQ scores with physiologic markers of IPF severity [ Time Frame: Baseline, 6, 12 and 18 months ]
   Change scores for the LCQ cough-related quality of life instrument will be correlated with changes in pulmonary function tests

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with IPF as defined by ATS guidelines

Criteria

Inclusion Criteria:

• Completion of informed consent.
• Adults over the age of 18.
• Diagnosis of IPF per ATS guidelines.
• Clinically stable at the time of enrollment defined as no antibiotics within the past month, with the exception of those patients currently listed for Lung Transplantation.
• No changes in immunosuppressive regimens (if applicable) over past month.

Exclusion Criteria:

• Inability to understand or complete paper and pencil questionnaires.
• Patient not planning to return to Stanford for clinic visits.

Contacts and Locations

Contacts

Contact: Susan S Jacobs, RN, MS; ssjpulm@stanford.edu

Locations

United States, California

Stanford University Medical Center, Chest Clinic

Stanford, California, United States, 94305-5236

Principal Investigator: Glenn D Rosen, MD

Sub-Investigator: Paul Mohabir, MD

Sub-Investigator: Jeff Swigris, DO

Sponsors and Collaborators

Stanford University

Celgene Corporation

Investigators

• Principal Investigator: Glenn D Rosen, MD; Stanford University

More Information

• Responsible Party: Glenn D. Rosen, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT01874223
• Other Study ID Numbers: 23346
• First Posted: June 10, 2013
• Last Update Posted: June 10, 2013
• Last Verified: June 2013

Keywords provided by Glenn D. Rosen, Stanford University:

Interstitial Lung Disease (ILD); Idiopathic Pulmonary Fibrosis (IPF)

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Dyspnea; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Respiratory Tract Diseases; Idiopathic Interstitial Pneumonias; Respiration Disorders; Signs and Symptoms, Respiratory