Clinical trial NCT01874223: Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With IPF
Official title: Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Keywords: Interstitial Lung Disease (ILD)
Idiopathic Pulmonary Fibrosis (IPF)
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2013-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with IPF as defined by ATS guidelines

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.

Eligibility 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.

Primary outcomes:
measure: Correlation of LCQ scores with physiologic markers of IPF severity
timeFrame: Baseline, 6, 12 and 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center, Chest Clinic
state: California
Study officials:
affiliation: Stanford University
name: Paul Mohabir, MD
role: PRINCIPAL_INVESTIGATOR
References: