Comparative study of the efficacy and safety of Formoterol, dry powder capsules for inhalation, 12 Âµg and Foradil, inhalation powder, capsules, 12 Âµg in patients with partially controlled bronchial asthmaâ??

Rus Biopharm LLC0 个研究点目标入组 136 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

发起方

Rus Biopharm LLC