Comparative study of the efficacy and safety of Formoterol
- Conditions
- Health Condition 1: null- In patients with partially controlled bronchial asthma
- Registration Number
- CTRI/2017/03/008277
- Lead Sponsor
- Rus Biopharm LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 136
1.Male and female patients 18 to 70 years of age inclusive.
2.Diagnosis of persistent asthma established according to the GINA guidelines (2015) not less than 6 months prior to the screening visit.
3.Need for combination bronchodilator therapy with long-acting beta-agonists in combination with inhaled glucocorticoids (IGC).
4.Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short-acting
beta-agonists (SABA) as on-demand therapy.
1.Patients for whom starting maintenance therapy for asthma has to be selected.
2.Contraindications for treatment with inhaled glucocorticoids, hypersensitivity to formoterol, salbutamol, or to any other ingredient included in the formulation of the investigational medicinal product, reference product, or salbutamol.
3.Galactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
4.Body mass index (BMI) > 35 kg/m2.
5.A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2015 version of the GOLD guidelines.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method