A clinical trial to assess the efficacy and safety of L-arginine inhalation in treatment of secondary pulmonary hypertension & associated diseases
- Registration Number
- CTRI/2010/091/001388
- Lead Sponsor
- Defence R&D Organisation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 113
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 or with hypoxemia at high altitude
2. Age group: 18-65 years
3. Ambulatory, preferably admitted patients for better follow up
4. Non-critically ill patients.
a) Healthy volunteers
1. Those who do not sign the ICF
2. Those who refuse to abide by the rules/briefing
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).
b) Diseased subjects
1. Patients with prior hypersensitivity to arginine
2. Patients who are unwilling to give informed consent.
3. Patients receiving oral or systemic arginine or other nitric acid donors or known to have increased indigenous nitric oxide production within 4 weeks of the start of the study.
4. Patients with history of attack of ?Status Asthmaticus? within 6 months prior to enrollment or having severe dyspnoea.
5. Patients on continuous oxygen
6. Volunteers with serious or critical illness.
7. Patients who are pregnant, lactating or women of child bearing potential not using medically accepted methods of contraception.
8. Patients with clinically significant renal, respiratory (other than those mentioned), cardiac (including rheumatic or congenital heart disease), gastrointestinal, hepatic, endocrine or hematological disorders.
9. Athletes on unknown nutraceutials.
10. Patients who have any medical condition which in the judgement of the investigator may render them in appropriate for participation in the trial.
11. 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 L-Arginine in ethanol nebulization in pulmonary hypertension of different causes <br><br>2. To evaluate the effect of short-term treatment with L-Arginine in ethanol nebulization on hypoxemia, PFT and in improvement of cardiopulmonary performance <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