A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in … (NCT04685720) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
Australia15 participantsStarted 2020-12-07
Plain-language summary
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
Who can participate
Age range18 Years
SexALL
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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 …