In patients with partially controlled bronchial asthma

International open multicenter randomized comparative study of pharmacokinetics, efficacy and safety of the medications RespinidÂ® (INN: budesonide), metered dose inhaler suspension, 0.5 mg/ml (BML PARENTERAL DRUGS, India) and PulmicortÂ®, metered dose inhaler suspension, 0.5 mg/ml (AstraZeneca AB, Sweden) in patients with partially controlled bronchial asthma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035351

Enrollment

224

Registered

2021-08-03

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: J452- Mild intermittent asthma

Interventions

Intervention1: RespinidÂ® budesonide: Pharmaceutical form metered-dose inhaler suspension Study Dosing Regime 1 mg (2 ml) through a nebulizer 2 times a day for not more than 88 days Control Interventi

Eligibility

Inclusion criteria

Inclusion criteria: 1 ACQ-5 questionnaire results >= 0.75 and 2. The indicator of the forced expiratory volume in 1 second (FEV1) before taking bronchodilators is at least 60% of the due. 3. A controller therapy of BA with low doses of iGCS for at least 1 month before the screening visit

Exclusion criteria

Exclusion criteria: 1. Patients in need of selection of starting maintenance therapy for BA. 2. Contraindications to the treatment of iGCS, hypersensitivity to budesonide, salbutamol or any components of the investigational medication, reference medication and salbutamol medication. 3. Body mass index (BMI) > 35 kg/m2

Design outcomes

Primary

Measure	Time frame
The variation value for FEV1 indicatorTimepoint: at Visits 1 and 4	—

Secondary

Measure	Time frame
Dynamics of FEV1 indicatorTimepoint: for Visits 2, 3 and 4.;Dynamics of quality of life indicators according to the SF-36 questionnaireTimepoint: at Visits 2 and 4.;Dynamics of the absolute PEF indicatorTimepoint: for Visits 2, 3 and 4.;Dynamics of the total score on the ACQ-5 BA control questionnaireTimepoint: at Visits 2, 3 and 4.;The frequency of patients who achieved BA control (total score in the ACQ-5 questionnaire 0.75)Timepoint: by Visit 4.;The frequency of patients who experienced exacerbations according to the classification of the severity of exacerbationsTimepoint: at Visits 2, 3 and 4.;Weekly average daily need for SABAs (Î¼g/day) (medication salbutamol)Timepoint: by Visit 2, 3 and 4.	—

Measure

Time frame

Dynamics of FEV1 indicatorTimepoint: for Visits 2, 3 and 4.;Dynamics of quality of life indicators according to the SF-36 questionnaireTimepoint: at Visits 2 and 4.;Dynamics of the absolute PEF indicatorTimepoint: for Visits 2, 3 and 4.;Dynamics of the total score on the ACQ-5 BA control questionnaireTimepoint: at Visits 2, 3 and 4.;The frequency of patients who achieved BA control (total score in the ACQ-5 questionnaire 0.75)Timepoint: by Visit 4.;The frequency of patients who experienced exacerbations according to the classification of the severity of exacerbationsTimepoint: at Visits 2, 3 and 4.;Weekly average daily need for SABAs (Î¼g/day) (medication salbutamol)Timepoint: by Visit 2, 3 and 4.

—

Countries

India, Russian Federation

Contacts

Public ContactDr S Sadgune

Mudra Clincare

dr.sayalitarte@gmail.com8291745386

Outcome results

None listed

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