Study of efficacy and safety of Formair
Not Applicable
- Conditions
- Health Condition 1: null- In patientswith partly controlled bronchial asthma.
- Registration Number
- CTRI/2017/01/007711
- Lead Sponsor
- Rus Biopharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
The diagnosis of persistent bronchial asthma (BA) is determined according to the Guidelines GINA (2015) not less than 6 months before the screening visit
The need for combined broncholytic therapy with long-acting β-agonist (LABA) together with inhaled glucocorticosteroids (IGCS)
The results of the questionnaire ACQ-5 >= 0.75 and <1.5 points
Exclusion Criteria
Patients in need of the selected starting supporting therapy of asthma.
Contraindications to IGCS therapy, hypersensitivity to Formoterol, Salbutamol, or any component of the study drug, reference drug and Salbutamol.
Body mass index (BMI) > 35 kg/m 2.
Chronic obstructive pulmonary disease (COPD), according to the version of the GOLD Guidelines (2015) has been diagnosed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in FEV1 index in 2 hours after inhalation on Visits 1and 4.Timepoint: 2 hrs
- Secondary Outcome Measures
Name Time Method Dynamics of FEV1 index in 2 hours after inhalation to Visits 2, 3 and 4.Timepoint: 2hrs;Dynamics of PEFR variability by Visits 2, 3 and 4.Timepoint: 2hrs