In patients with partially controlled bronchial asthma

Phase 3

Suspended

• Conditions: Health Condition 1: J22- Unspecified acute lower respiratory infection

• Registration Number: CTRI/2020/02/023113
• Lead Sponsor: PSK Pharma LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-05-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Signed Informed Consent Form of the Patient Information Sheet (PIS) for participation in the clinical study

- Male and female patients aged 18 through 70 at the time of signing the Informed Consent Form of PIS

-Diagnosis of persistent BA, established according to the GINA guidelines, in 2018 at least 6 months before the screening visit

-The need for broncholytic therapy with IGCS in combination with long-acting-β-agonists (LABA)

Exclusion Criteria

- Patients with the need for selection of initial maintenance therapy of BA.

- Contraindications to the use of iGCS, hypersensitivity to Beclomethasone, Formoterol, Salbutamol or any components of the study product.

- Diagnosis of COPD, established according to the GOLD guidelines, 2018.

- Use of glucocorticosteroids (GCS), either oral or for parenteral administration, less than 2 months before the screening visit (3 months for parenteral long-acting GCS).

-Conditions requiring the use of systemic GCS at the time of the screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the PEF1 valueTimepoint: Visits 1 and 4

Secondary Outcome Measures

Name	Time	Method
1. Changes in FEV1 <br/ ><br>2. Changes in PEF <br/ ><br>3. Changes of the index according to the ACQ-5 questionnaire <br/ ><br>4. Changes in quality of life indicators (QOL) according to the SF-36 <br/ ><br>5. Number of patients who have reached BA control <br/ ><br>6. Average weekly need for SABA <br/ ><br>7. Number of patients with exacerbationsTimepoint: 1. 2 hours after the inhalation of the study product/comparator <br/ ><br>2. Visits 2, 3 and 4 <br/ ><br>3. Change over time <br/ ><br>4. Change over time <br/ ><br>5. Visit 4 <br/ ><br>6. weeks 1, 4, 8 and 12 <br/ ><br>7. visits 2, 3 and 4