A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avi (ARISE)
The primary objective of this study is to generate evidence demonstrating the domain
specification (via modern psychometric methods), reliability, validity, and responsiveness
(within-subject meaningful change) of the Patient-Reported Outcome (PRO) endpoints.
Participants will also complete the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT),
EXACT Respiratory Symptoms (EXACT-RS), St. George Respiratory Questionnaire (SGRQ),
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Patient
Global Impression of Severity - Respiratory (PGIS-Respiratory), and Patient Global Impression
of Severity - Fatigue (PGIS-Fatigue) at baseline and throughout the study as anchors for the
validation of the QoL-B and PROMIS F-SF 7a.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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