Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04677543

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

Mycobacterium Infections, Nontuberculous Clinical Trial

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 Avi

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04677543
Study type Interventional
Source Insmed Incorporated
Contact
Status Completed
Phase Phase 3
Start date December 22, 2020
Completion date May 9, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT03038178 - Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease Phase 2
Active, not recruiting NCT04922554 - Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc) Phase 2
Terminated NCT04154826 - Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease Phase 2
Completed NCT02344004 - Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone Phase 3
Recruiting NCT06266442 - M. Avium WGS During Mav-PD Treatment
Recruiting NCT02355015 - A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections N/A
Completed NCT03421743 - Pilot Trial of Inhaled Molgramostim in Nontuberculous Mycobacterial (NTM) Infection Phase 2
Not yet recruiting NCT06418711 - ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension Phase 3
Terminated NCT03597347 - Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection Phase 2
Completed NCT02832843 - Genome-Wide Association Study in Patients With Nontuberculous Mycobacterial Lung Disease
Completed NCT02340897 - Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT N/A
Completed NCT01315236 - Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria Phase 2
Recruiting NCT04677569 - Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex Phase 3