In patients with partially controlled bronchial asthma

International open-label randomized comparative study of the efficacy and safety of Beclomethasone+Formoterol drug products, metered-dose inhaler, 100+6 Î¼g/dose (LLC â??PSK Pharmaâ??, Russian Federation) and Foster, metered-dose inhaler, 100+6 Î¼g/dose (Chiesi Farmaceutici S.P.A., Italy) in patients with partially controlled bronchial asthma.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023113

Enrollment

140

Registered

2020-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Beclomethasone plus Formoterol: 1 inhalation of 100+6 Î¼g/dose BID Control Intervention1: Foster: 1 inhalation of 100+6 Î¼g/dose 2 times per day Control Intervention2: Foster: 1 inhalat

Eligibility

Inclusion criteria

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-Î²-agonists (LABA)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change in the PEF1 valueTimepoint: Visits 1 and 4	—

Secondary

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

Measure

Time frame

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

—

Countries

India, Russian Federation

Contacts

Public ContactDr Harshad D

Mudra Clincare

mudraclincare@gmail.com8850102096

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026