A clinical trial to assess the efficacy and safety of sodium nitrite inhalation in treatment of secondary pulmonary hypertension & hypoxemic conditions

Phase 2

• Registration Number: CTRI/2010/091/001389
• 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: 158

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>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<br>Timepoint: NI

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the effect of treatment with study medication on pulse oximetry, exercise performance, patient acceptance<br>2. To evaluate the safety and tolerability of study medication<br>3. To generate further pharmacokinetic data of the drug and peak methemoglobin formation.<br>4. To evaluate the physicians and patients overall assessment of the effectiveness and tolerability of the study medication <br>Timepoint: NI