None listed
Conditions
Interventions
Intervention1: 3% sodium nitrite in 30% ethanol-saline nebulization: One millilitre of the study medication to be inhaled through nebulization device 3-4 times a day for 5-7 days
Control Intervention1
Sponsors
Defence R&D Organisation
Eligibility
Inclusion criteria
Inclusion criteria: a) Healthy volunteers 1. Healthy Males/females, between 18-45 years ages group 2. On no permanent treatment 3. Suffering from no permanent / recurrent / chronic disease or disability b) Diseased subjects 1. Worked up adult patients with pulmonary hypertension with associated hypoxemia, mild or moderate asthma or COPD or ILD with hypoxemia. 2. Stable treatment and symptoms history 3. Age group: 18-65 years 4. Ambulatory, preferably admitted or confined patients for better follow up 5. Non-critically ill patients 6. No need to stop medication
Exclusion criteria
Exclusion criteria: a)Healthy volunteers 1. Those who do not sign the ICF 2. Those who have had any medical condition which in the judgement of the investigator may render them inappropriate for participation in the trial or who cannot inhale properly 3. Patients who have received any other investigational drug for the last 1 month. 4. Too low or too high body weight (< 40 kg, > 100 kg) 5. Pregnant & lactating women b) Diseased subjects 1. Patients with prior hypersensitivity to nitrates 2. Patients who are unwilling to give informed consent. 3. Patients receiving oral or systemic nitric acid donors or known to have increased indigenous nitric oxide production within 4 weeks of the start of the study. 4. Patients on continuous oxygen 5. Volunteers with serious or critical illness. 6. Patients who are pregnant, lactating or women of child bearing potential not using medically accepted methods of contraception. 7. Patients with clinically significant renal, respiratory (other than those mentioned), cardiac (including rheumatic or congenital heart disease), gastrointestinal, hepatic, endocrine or hematological disorders. 8. Patients who have any medical condition which in the judgement of the investigator may render them inappropriate for participation in the trial. 9. Patients who have received any other investigational drug for the last 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of short-term treatment with inhaled sodium nitrite in ethanol nebulization in pulmonary hypertension of different causes and in hypoxemia states 2. To evaluate the effect of short-term treatment with inhaled sodium nitrite in ethanol nebulization on hypoxemia, PFT and in improvement of cardiopulmonary performance in different disease conditions Timepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of treatment with study medication on pulse oximetry, exercise performance, patient acceptance 2. To evaluate the safety and tolerability of study medication 3. To generate further pharmacokinetic data of the drug and peak methemoglobin formation. 4. To evaluate the physicians and patients overall assessment of the effectiveness and tolerability of the study medication Timepoint: NIL | — |
Countries
India
Contacts
Public ContactAseem Bhatnagar
Institute of Nuclear Medicine & Allied Sciences, Defence R&D Organisation, Ministry of Defence
Outcome results
None listed