Health Condition 1: J452- Mild intermittent asthma
Conditions
Interventions
Intervention1: Asmidine Spray: Dosage form Metered-dose inhaler
Dosing regimen within the study 2 sprays in each nostril, 3 times a day
Duration 80 days
Control Intervention1: Salbutamol: Dosage form
Sponsors
VITROBIO SAS
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1 Signed Informed consent form for participation in the clinical study. 2 6. Forced expiratory volume - 1 second (FEV1) before the use of broncholytics not less than 60% of proper value (at screening visit or at the moment of test within 30 days before screening visit). 3 Positive result of the test for reversibility of airway obstruction, expressed as Î?FEV1 >=12% and >=200 ml vs.
Exclusion criteria
Exclusion criteria: 1 Diagnosis of COPD, established according to the GOLD guidelines, ver. 2018. 2 6. Conditions requiring the use of systemic GCS at the time of the screening visit. 3. Unexpected and progressive deterioration of control of symptoms of BA. 4. Unstable course of bronchial asthma, hospitalization due to exacerbation of bronchial asthma in the intensive care unit using intubation, frequent exacerbations of asthma 5. Pulmonary tuberculosis (active or inactive form). 6. covid positve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the PEF1Timepoint: weeks 1, 4, 8 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in FEV1 valueTimepoint: 2 hours after the inhalation of the study/reference product.;Changes of the index according to the ACQ-5 questionnaire for evaluation of BA controlTimepoint: from baseline.;Evolution of the PEF valueTimepoint: as measured at Visits 2, 3 and 4. | — |
Countries
India
Contacts
Public ContactDr S Sadgune
Mudra Clincare
Outcome results
None listed