None listed
Conditions
Interventions
Intervention1: 1 MG Sodium nitroprusside reconstituted in 1 ML 10% ethanol-saline as respiratory fluid: One millilitre of the test formulation to be inhaled through nebulization device supplied by INM
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 mild or moderate asthma or COPD or ILD with hypoxemia. Wherever facilities are not available, for example at high altitude, clinical diagnosis shall be deemed sufficient as per accepted norms. 2. Age group: 18-65 years 3. Ambulatory, preferably admitted patients for better follow up 4. Non-critically ill patients.
Exclusion criteria
Exclusion criteria: a) Healthy volunteers 1. Those who do not sign the ICF 2. Those who refuse to abide by the rules/briefing and are not able to inhale aerosols as per instructions. 3. Those who have had any medical condition which in the judgement of the investigator may render them inappropriate for participation in the trial. 4. Patients who have received any other investigational drug for the last 1 month. 5. Too low or too high body weight (< 40 kg, > 100 kg) 6. 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 with cyanosis or respiratory failure or on ventilatory support with minimal response (relative criteria ? may be included as a life-saving measure with appropriate written disclosures and disclaimers) 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 nitroprusside in ethanol nebulization in pulmonary hypertension of different causes 2. To evaluate the effect of short-term treatment with inhaled sodium nitroprusside in ethanol nebulization on hypoxemia, PFT and in improvement of cardiopulmonary performance Timepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of treatment with study medication on pulse oximetry, symptomatology, patient acceptance 2. To evaluate the safety and tolerability of study medication 3. To generate further pharmacokinetic data of the drug and peak methemoglobin, cyanide, thiocyanide levels 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