Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With IPF

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305-5236
      • Stanford University Medical Center, Chest Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with IPF as defined by ATS guidelines

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Celgene Corporation
• Investigators: Principal Investigator: Paul Mohabir, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): January 4, 2018
• Study Completion (Actual): November 4, 2018

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Idiopathic Pulmonary Fibrosis (IPF); Interstitial Lung Disease (ILD)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Fibrosis; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Dyspnea
• Other Study ID Numbers: 23346