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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Stanford University
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Glenn D. Rosen, Stanford University
ClinicalTrials.gov Identifier:
NCT01874223
First received: May 6, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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
Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Correlation of LCQ scores with physiologic markers of IPF severity [ Time Frame: Baseline, 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Change scores for the LCQ cough-related quality of life instrument will be correlated with changes in pulmonary function tests


Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874223

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

Locations
United States, California
Stanford University Medical Center, Chest Clinic Not yet recruiting
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

No publications provided

Responsible Party: Glenn D. Rosen, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01874223     History of Changes
Other Study ID Numbers: 23346
Study First Received: May 6, 2013
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Interstitial Lung Disease (ILD)
Idiopathic Pulmonary Fibrosis (IPF)

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014