CTRI/2021/06/034142Not yet recruiting未知
An open-label, randomized, comparative study of the preventive efficacy and safety of Asmidine Spray, metered-dose inhaler versus Salbutamol, metered-dose inhaler, in patients with partially controlled asthma.
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- VITROBIO SAS
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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