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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01874223
Other study ID # 23346
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2013
Est. completion date November 4, 2018

Study information

Verified date August 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 4, 2018
Est. primary completion date January 4, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States Stanford University Medical Center, Chest Clinic Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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