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

NCT01874223 | Completed

• 1 other identifier: 23346
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with IPF as defined by ATS guidelines

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Stanford University Medical Center, Chest Clinic

Stanford, California, 94305-5236, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis

Study Officials

• Paul Mohabir, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: June 10, 2013
• Study Start: June 1, 2013
• Primary Completion: January 4, 2018
• Study Completion: November 4, 2018
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (1)