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

Completed

• Conditions: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease

• Registration Number: NCT01874223
• Lead Sponsor: Stanford University

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.

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 Timeline

• Study First Submitted: 2013-05-06
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Primary Completion: 2018-01-04
• Study Completion: 2018-11-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of LCQ scores with physiologic markers of IPF severity	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

Trial Locations

Locations (1)

Stanford University Medical Center, Chest Clinic; 🇺🇸 Stanford, California, United States