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Completed Phase 3 Interventional Results available

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ClinicalTrials.gov ID: NCT04677543

Public ClinicalTrials.gov record NCT04677543. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 7:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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 Avium Complex (MAC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04677543
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Insmed Incorporated
Industry
Enrollment
99 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 21, 2020
Primary completion
May 8, 2023
Completion
May 8, 2023
Last update posted
Jun 27, 2024

2020 – 2023

United States locations

U.S. sites
27
U.S. states
16
U.S. cities
27
Facility City State ZIP Site status
USA008 Birmingham Alabama 35233-1711
USA062 Fresno California 93701-2302
USA048 San Diego California 92121-3018
USA050 Stanford California 94305
USA023 Washington D.C. District of Columbia 20007
USA003 Clearwater Florida 33765
USA072 Jacksonville Florida 32207-8567
USA042 Kissimmee Florida 34746
USA039 Naples Florida 34102-5444
USA014 St. Petersburg Florida 33707
USA067 Tampa Florida 33606-3603
USA066 Augusta Georgia 30912-0004
USA029 Rincon Georgia 31326
USA037 Kansas City Kansas 66160
USA017 Baltimore Maryland 21224-3057
USA061 St Louis Missouri 63110-1035
USA069 Hillsborough New Jersey 08844-1528
USA065 Bayside New York 11361
USA011 New York New York 10017-6739
USA051 Durham North Carolina 27710-0001
USA025 Portland Oregon 97239
USA040 Philadelphia Pennsylvania 19104-4238
USA044 Anderson South Carolina 29621-5708
USA024 Charleston South Carolina 29414
USA022 Franklin Tennessee 37067-5603
USA021 McKinney Texas 75069-8085
USA052 Tyler Texas 75708-3154

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04677543, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 27, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04677543 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →