A clinical trial to assess the efficacy and safety of L-arginine inhalation in treatment of secondary pulmonary hypertension & associated diseases

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: 1.25% L‐arginine in 30% alcohol‐saline respiratory fluid: The test formulation is to be inhaled using INMAS spacer 3‐4 times a day for 3‐7 days or as directed by the investigator Control Intervention1: Commercially available micronized salbutamol sulphate DPI/MDI: Control formulation to be inhaled 3‐4 times a day for 3‐7 days or as directed by the investigator CONDITION: Patients suffering from bronchial asthma, COPD & high altitude hypoxemia‐PHT PRIMARY OUTCOME: 1. To evaluate the effect of short‐term treatment with L‐Arginine in ethanol nebulization in pulmonary hypertension of different causes ; ; 2. To evaluate the effect of short‐term treatment with L‐Arginine in ethanol nebulization on hypoxemia, PFT and in improvement of cardiopulmonary performance ; ‐‐‐‐‐‐Timepoint: NIL SECONDARY OUTCOME: 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 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 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.
Epistemonikos ID: be13e69bc844f2c8a154ec4c340f1b810ad81f40
First added on: Aug 22, 2024