| CTRI Number |
CTRI/2021/08/035351 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In patients with partially controlled bronchial asthma |
|
Scientific Title of Study
|
International open multicenter randomized comparative study of pharmacokinetics, efficacy and safety of the medications Respinid® (INN: budesonide), metered dose inhaler suspension, 0.5 mg/ml (BML PARENTERAL DRUGS, India) and Pulmicort®, metered dose inhaler suspension, 0.5 mg/ml (AstraZeneca AB, Sweden) in patients with partially controlled bronchial asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BUD-4/20, Version: 1.0 dated 19.05.2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Room No. 2, Department of Research 1st Floor, B Wing, Sector 18, Kamothe
Raigarh
MAHARASHTRA
410206
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Room No. 2, Department of Research 1st Floor, B Wing, Sector 18, Kamothe
Raigarh
MAHARASHTRA
410206
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Room No. 2, Department of Research 1st Floor, B Wing, Sector 18, Kamothe
Raigarh
MAHARASHTRA
410206
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSK Pharma LLC, 2 Programmistov 4, premise 215, Dubna town, Moscow Region 141983 |
|
|
Primary Sponsor
|
| Name |
PSK Pharma LLC |
| Address |
2 Programmistov 4, premise 215, Dubna town, Moscow Region
141983 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mudra Clincare |
Room No. 2,
1st Floor, B Wing,
Sector 18, Kamothe |
|
|
Countries of Recruitment
|
India
Russian Federation |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Mulay |
Orchid Hospital |
Department of
Medicine, Room No. 2,
1st Floor, B Wing,
Sector 18, Kamothe.
Raigarh
MAHARASHTRA |
7400137496
drumamulay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Altezza Institutuional Ethics Committe, Shree Ashirwad Hospital, Dombivli, ,Maharshtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pulmicort(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 |
| Intervention |
Respinid® 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 ACQ-5 questionnaire results ≥ 0.75 and < 1.5 points
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The variation value for FEV1 indicator |
at Visits 1 and 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dynamics of FEV1 indicator |
for Visits 2, 3 and 4. |
| Dynamics of the absolute PEF indicator |
for Visits 2, 3 and 4. |
| Dynamics of the total score on the ACQ-5 BA control questionnaire |
at Visits 2, 3 and 4. |
| Dynamics of quality of life indicators according to the SF-36 questionnaire |
at Visits 2 and 4. |
| The frequency of patients who achieved BA control (total score in the ACQ-5 questionnaire 0.75) |
by Visit 4. |
| Weekly average daily need for SABAs (μg/day) (medication salbutamol) |
by Visit 2, 3 and 4. |
| The frequency of patients who experienced exacerbations according to the classification of the severity of exacerbations |
at Visits 2, 3 and 4. |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="194"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/07/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="19" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bronchial asthma (BA) – heterogeneous disease that is characterized by chronic inflammation of the airways and is accompanied by respiratory symptoms such as sibilant rale, shortness of breath, chest congestion, and coughing. These symptoms vary in time and intensity and manifest along with variable airway obstruction One of the most effective and safe medications in this group is budesonide. Its distinctive features among other iGCSs are high activity against HA-receptors, intermediate lipophilicity and prolonged tissue retention due to conjugation with fatty acids |