Phase
Condition
Mac Infection (Mycobacterium Avium Complex)
Hiv
Treatment
Hypertonic Saline inhalation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
International guideline criteria for nodular-bronchiectatic MAC lung disease, i.e.symptomatic, nodular bronchiectatic lesions seen on thorax radiography and ≥2positive cultures of the same MAC species or one positive culture from abronchoalveolar lavage;
≥1 positive MAC sputum cultures must be collected in the previous 4 months;
Signed and dated patient informed consent.
Exclusion
Exclusion Criteria:
Fibrocavitary MAC lung disease;
Antimycobacterial treatment in the last 6 months;
Previous MAC lung disease treatment failure, defined as persistent culturepositivity despite >6 months of guideline-recommended treatment;
Current clinical relevant asthma or otherwise bronchial hyperresponsiveness that isjudged to be a contra-indication for HSi.
Current HSi use
Former adverse reaction to HSi (note: former HSi use that was stopped due to a lackof clinical improvement is not an exclusion criterium);
Hypertonic saline intolerability during the screening test inhalation
Diagnosis of HIV;
Diagnosis of Cystic fibrosis (CF);
Active pulmonary malignancy (primary or metastatic) or any other malignancyrequiring chemotherapy or radiotherapy within 6 months before screening oranticipated during the study period;
Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment
Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months
Prior lung or other solid organ transplant
Known or suspected current drug or alcohol abuse, that is, in the opinion of theInvestigator, sufficient to compromise the safety or cooperation of the patient.
Study Design
Study Description
Connect with a study center
Radboud University Medical Center
Nijmegen, 6225GA
NetherlandsActive - Recruiting
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