Comparative study of the efficacy and safety of Formoterol

Phase 3

Not yet recruiting

• Conditions: In patients with partially controlled bronchial asthma

• Registration Number: CTRI/2017/03/008277
• Lead Sponsor: Rus Biopharm LLC

Brief Summary

This study is designed as anopen-label, multicentre, randomized, comparative trial.

The total duration of the Study for each patient willnot exceed 109 days, of which the duration of screening will not exceed 14days, the duration of the treatment period 84 days, and the duration of thefollow-up period 11 days.

The study will include the following periods:

**Study Visits**

Visit 0 (screening, Day -14 ... -1);

Visit 1 (randomization, Day 1);

Visit 2 (interim visit, Day 14 ± 2);

Visit 3 (interim visit, Day 56 ± 2);

Visit 4 (completion of therapy, Day 86 ± 2);

Visit 5 (telephone call, Day 93 ± 2).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-03-29
• Study Start: 2017-04-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
Change in FEV1	By the 2nd hour post inhalation during Visits 1 and 4.

Secondary Outcome Measures

Name	Time	Method
Change in FEV1	by the 2nd hour post inhalation during Visits 2, 3, and 4.
Changes in absolute PEF	by Visits 2, 3, and 4.
Total ACQ-5 (asthma control questionnaire) score changes	by Visits 2, 3, and 4.
SF-36 (quality of life questionnaire) score changes	by Visits 2 and 4.
Proportion of patients achieving asthma control (total ACQ-5 score 0.75)	by Visit 4.

Trial Locations

Locations (1)

Hi Tech Medical College & Hospital; 🇮🇳 Khordha, ORISSA, India

Hi Tech Medical College & Hospital

🇮🇳Khordha, ORISSA, India

Dr Sarat Kumar Behera

Principal investigator

9439129178

behera.saiprasanna82@gmail.com