Health Condition 1: null- In patients with partly controlled bronchial asthma.
Conditions
Interventions
Intervention1: Trade name: Formair
International non-proprietary name: Formoterol
Dosage form: metered-dose inhaler: Description:
The white suspension is pressurized in the cylinder of stainless steel
Sponsors
Rus Biopharm
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in FEV1 index in 2 hours after inhalation on Visits 1and 4.Timepoint: 2 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed