Safety and efficacy of inhaled sodium nitrite in patients with persistent asthma
- Conditions
- Asthmanitriteasthma
- Registration Number
- TCTR20190222004
- Lead Sponsor
- Mahidol university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
Patients with persistent asthma with informed consent.
The eligible patients have persistent asthmatic symptoms (wheezing, cough, or shortness of breath) for at least 6 months, and must be able to do lung function test or body plethysmography.
Patients with aspirin-induced asthma, exercise-induced asthma, history of bronchopulmonary dysplasia, smoking, fixed airflow obstruction determined by spirometry, any other serious respiratory diseases other than asthma, acute asthma exacerbation or respiratory tract infection within 4 weeks of visit 1, frequent use of albuterol as rescue medication (> 6 MDI puffs per day or > 3 nebulized treatment per day on more than 2 consecutive days), hypersensitivity to sodium nitrite or any components in the inhalation solution, any history of heart disease, any malignancy, narrow-angle glaucoma, moderate-to-severe renal impairment, unwilling to enroll or withdraw consent at any time of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Changes in FEV1 from time zero, at times 0, 30, 60, 120, 180 min and 12 week after nebulization Body sphlegnography,Adverse events from sodium nitrite from time zero, at times 0, 30, 60, 120, 180 min, 4 week, 8 week and 12 week after nebulization Dizziness, flushing
- Secondary Outcome Measures
Name Time Method Monitored clinical 0, 4, 8,12 wk Asthma Control Test (ACT),Change in exhaled NO (FENO) from time zero, at times 5, 30, 45, and 60 min after nebulization Chemiluminescence,Change in systolic blood pressure, heart rate, oxygen saturation from time zero, at times 0, 30, 60, 120, 180 min, 4 week, 8 week and 12 week after nebulization Blood pressure, HR, O2 saturation measurement,Change in methemoglobin in venous blood From time zero and at times 120 min after nebulization Spectrophotometry,Renal clearance of nitrite from time zero to 120 min after nebulization Urinary nitrite by chemiluminescence,Change in platelet activity from times zero, at time 0, 60 min after nebulization Flow cytometry,Change in air trapping from time zero, at times 0, 30, 60, 120, 180 min and 12 week after nebulization Body sphlegnography