A clinical trial to assess the efficacy and safety of sodium nitroprusside inhalation in treatment of secondary pulmonary hypertension & hypoxemic conditions (as a life saving/supporting procedure)

Phase 2

• Registration Number: CTRI/2010/091/001390
• Lead Sponsor: Defence R&D Organisation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 135

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified