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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • participants needed
    100
  • sponsor
    Insmed Incorporated
Updated on 16 September 2021
Investigator
Insmed Medical Information
Primary Contact
USA046 (5.4 mi away) Contact
+132 other location

Summary

The primary objective of this study is to generate evidence demonstrating the domain specification via modern psychometric methods, reliability, validity, and responsiveness of Quality of Life - Bronchiectasis (QoL-B) and Patient-Reported Outcome Measurement Information System - Fatigue-Short Form (PROMIS F-SF 7a) in participants with newly diagnosed nontuberculous mycobacterial (NTM) lung infection caused by Myobaxterium avium Complex (MAC).

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.

Details
Condition Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous
Treatment ethambutol, Azithromycin, ALIS, ELC, ELC
Clinical Study IdentifierNCT04677543
SponsorInsmed Incorporated
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, 18 years of age (20 years or older in Japan)
Current diagnosis of Myobacterium avium Complex (MAC) lung infection (initial, second, or third infection event)
Positive sputum culture for MAC within 6 months prior to screening
A high-resolution chest computerized tomography (CT) scan or chest CT scan with contrast, read locally, within 6 months prior to Screening and provided to the Sponsor. Participants who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a high resolution chest CT scan or chest CT scan with contrast, read locally, during Screening
Adherence to a predefined multidrug antimycobacterial regimen during the study
Ability to produce (spontaneously or with induction) approximately 2mL of sputum for mycobacteriology at screening
Women of child-bearing potential (WOCBP) agree to practice an acceptable method of birth control (eg, true abstinence [refraining from heterosexual intercourse during the entire study], copper intrauterine device (IUD), hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill [combined with barrier method] or double barrier method plus a spermicidal agent, exclusive homosexual relationship, or sole male partner who has undergone surgical sterilization with confirmation of azoospermia at least 3 months post procedure) while participating in the study
Provide signed informed consent prior to administration of study drug or performing any study related procedure
Be able to comply with study drug use, study visits, and study procedures as defined by the protocol

Exclusion Criteria

Diagnosis of cystic fibrosis (CF)
History of 3 or more prior MAC lung infections
Received any mycobacterial antibiotic treatment for current MAC lung infection
Refractory MAC lung infection, defined as having positive MAC cultures while being treated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment, defined as negative sputum culture for MAC and cessation of treatment
Relapse of prior MAC lung infection, defined as positive sputum culture for MAC 6 months of cessation of prior successful treatment
Evidence of any pulmonary cavity 2 cm in diameter, as determined by chest CT scan, read locally, within 6 months prior to Screening
Radiographic finding of new lobar consolidation, atelectasis, significant pleural effusion, or pneumothorax during routine clinical care within 2 months prior to Screening
Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study
Acute pulmonary exacerbation (eg, chronic obstructive pulmonary disease [COPD] or bronchiectasis) requiring treatment with antibiotics, or corticosteroids (intravenous [IV] or oral), within 4 weeks prior to and during Screening
Current smoker
History of lung transplantation
Prior exposure to amikacin liposome inhalation suspension (ALIS) (including clinical study)
Known hypersensitivity to aminoglycosides
Disseminated MAC infection
Positive pregnancy test or lactation at Screening. All WOCBP will be tested. Women not of childbearing potential are defined as postmenopausal (ie, amenorrheic for 12 months without an alternative medical cause), or naturally or surgically sterile through bilateral oophorectomy, hysterectomy, or bilateral salpingectomy. For women under the age of 45, confirmatory testing with follicle stimulating hormone should be considered.)
Administration of any investigational drug within 8 weeks prior to Screening
Acquired and primary immunodeficiency syndromes (eg, HIV-positive, regardless of CD4 counts)
Current alcohol, medication, or illicit drug abuse
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