Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04685720
Eligibility Criteria:
Inclusion Criteria:
* Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection
* CF and Non-CF patients
Exclusion Criteria:
* Diagnosis of methemoglobinemia or MetHb ≥2% at screening; treatment with any drug known to increase MetHb; known or suspected hemoglobinopathy.
* History of or current myeloproliferative disease, leukemia or other hematological malignancy; known or suspected immunodeficiency disease.
* Subjects with advanced cardiovascular disease or CHF
* Use of an investigational drug during the 30 days prior to enrollment.
* History of frequent epistaxis (\>1 episode/month); significant hemoptysis (during the 30 days prior to enrollment.
* Subject on non-constant dose of systemic steroids within 30 days prior to enrollment; subjects on constant systemic steroids if the daily dose is higher than 10 mg/d prednisolone or equivalent.
* Active pulmonary malignancy (primary or metastatic) or any malignancy; history of lung transplantation.
* Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
* Uncontrolled hypertension within 3 months prior to or at screening
* Diagnosis of significant pulmonary hypertension indicated on echocardiogram at screening
* Clinically significant renal or liver laboratory abnormalities
* History of daily, continuous oxygen supplementation.
* Women of childbearing potential - pregnant or breastfeeding, or not on medically acceptable double methods of contraception from enrollment until Day 84.
* Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study.
* Patient receiving drugs that have a contraindication with NO
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04685720
Study Brief:
Protocol Section:
NCT04685720