Safety and efficacy of inhaled sodium nitrite in patients with persistent asthma

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190222004

Enrollment

160

Registered

2019-02-22

Start date

2019-02-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma nitrite asthma

Interventions

Sodium nitrite solution administered by inhaled nebulization to asthma patients ,Normal treatment and placebo

Experimental Drug,Experimental Drug

Nebulized sodium nitrite in asthma patients ,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Thailand

Contacts

Public ContactNathawut Sibmooh

Mahidol university

nathawut.sib@mahidol.ac.th6622015509

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026