preventive efficacy and safety of Asmidine Spray, metered-dose inhaler in patients with partially controlled asthma.
- Conditions
- Health Condition 1: J452- Mild intermittent asthma
- Registration Number
- CTRI/2021/06/034142
- Lead Sponsor
- VITROBIO SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the PEF1Timepoint: weeks 1, 4, 8 and 12.
- Secondary Outcome Measures
Name Time Method 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.