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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    100
  • sponsor
    Insmed Incorporated
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Updated on 10 August 2022
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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.

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
Treatment ethambutol, Azithromycin, ALIS, ELC, ELC
Clinical Study IdentifierNCT04677543
SponsorInsmed Incorporated
Last Modified on10 August 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female, ≥ 18 years of age (19 years or older in South Korea)
Current diagnosis of Mycobacterium avium Complex (MAC) lung infection
Positive sputum culture for MAC within 6 months prior to screening
A chest computed tomography (CT) scan, read locally, within 6 months prior to Screening to determine presence and size of pulmonary cavities. Participants who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a chest CT scan, read locally, during Screening
Willingness and ability to adhere to prescribed study treatment during the study
Ability to produce (spontaneously or with induction) approximately 2 mL of sputum for mycobacteriology at Screening
Women of child-bearing potential (WOCBP) (ie, fertile following menarche and until becoming post-menopausal unless permanently sterile) and fertile men (ie, all men after puberty unless permanently sterile by bilateral orchidectomy) agree to practice a highly effective method of birth control from Day 1 to at least 90 days after the last dose. Examples of such birth controls are
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])
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 drugs or performing
any study related procedure
Be able to comply with study drugs use, study visits, and study procedures as defined by the protocol
Men with partners who are WOCBP (pregnant or non-pregnant) agree to use condoms and non-pregnant partners should practice a highly effective method of birth control

Exclusion Criteria

Diagnosis of cystic fibrosis (CF)
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
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
History of more than 3 MAC lung infections
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
Relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤ 6 months of cessation of prior successful treatment
Prior exposure to amikacin liposome inhalation suspension (ALIS) (including clinical study)
Evidence of any pulmonary cavity ≥ 2 cm in diameter, as determined by chest CT scan, read locally, within 6 months prior to Screening
Disseminated MAC infection
Administration of any investigational drug within 8 weeks prior to Screening
Current alcohol, medication, or illicit drug abuse
Known hypersensitivity or contraindications to use to ALIS, aminoglycosides, or any of their excipients
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 confirmed by more than one follicle stimulating hormone [FSH] measurement), or naturally or surgically sterile through bilateral oophorectomy, hysterectomy, or bilateral salpingectomy. For women under the age of 45 years, confirmatory testing with FSH should be considered
Known or suspected acquired immunodeficiency syndromes (HIV-positive, regardless of CD4 counts). Other immunodeficiency syndromes that may interfere with study participation in the opinion of the Investigator
Known and active COVID-19 infection
MAC isolate with MIC for clarithromycin ≥ 32 µg/mL at Screening
Known hypersensitivity or contraindications to use to ethambutol, azithromycin (including other macrolides or ketolides), or any of their excipients per local labeling guidance
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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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