| CTRI Number |
CTRI/2021/06/034142 [Registered on: 10/06/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
preventive efficacy and safety of Asmidine Spray, metered-dose inhaler in patients with partially controlled asthma. |
|
Scientific Title of Study
|
An open-label, randomized, comparative study of the preventive efficacy and safety of Asmidine Spray, metered-dose inhaler versus Salbutamol, metered-dose inhaler, in patients with partially controlled asthma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol Number AST-4/21, Version: 1.0 Date: April 24, 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 |
Plot No 80, Sector 8, Koparkhairane Navi Mumbai, India
Mumbai (Suburban)
MAHARASHTRA
400709
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Plot No 80, Sector 8, Koparkhairane Navi Mumbai, India
MAHARASHTRA
400709
India |
| Phone |
|
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Plot No 80, Sector 8, Koparkhairane Navi Mumbai, India
MAHARASHTRA
400709
India |
| Phone |
|
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
|
Source of Monetary or Material Support
|
| VITROBIO SAS ZAC de Lavaur 63500 Issoire, France |
|
|
Primary Sponsor
|
| Name |
VITROBIO SAS |
| Address |
ZAC de Lavaur 63500 Issoire, France |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mudra Clincare |
Plot No. 80, Sector - 8, Koparkhairane, Navi Mumbai-400709, Maharashtra, INDIA. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaibhav Joshi |
Dnyaneshwari Clinic and Hospital |
Department of Medicine 1st Floor, Awaskar Building, Pen, Raigad, Maharashtra.
Mumbai (Suburban)
MAHARASHTRA |
9004757987
drvaibhavj1980@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. Ayurveda Condition: k, kha, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asmidine Spray |
Dosage form Metered-dose inhaler
Dosing regimen within the study 2 sprays in each nostril, 3 times a day
Duration 80 days |
| Comparator Agent |
Salbutamol |
Dosage form Metered-dose inhaler
Dosing regimen within the study 2 sprays in each nostril, 3 times a day
Duration 80 days |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Signed Informed consent form for participation in the clinical study.
2 6. Forced expiratory volume - 1 second (FEV1) before the use of broncholytics not less than 60% of proper value (at screening visit or at the moment of test within 30 days before screening visit).
3 Positive result of the test for reversibility of airway obstruction, expressed as ΔFEV1 ≥12% and ≥200 ml vs.
|
|
| ExclusionCriteria |
| Details |
1 Diagnosis of COPD, established according to the GOLD guidelines, ver. 2018.
2 6. Conditions requiring the use of systemic GCS at the time of the screening visit.
3. Unexpected and progressive deterioration of control of symptoms of BA.
4. Unstable course of bronchial asthma, hospitalization due to exacerbation of bronchial asthma in the intensive care unit using intubation, frequent exacerbations of asthma
5. Pulmonary tuberculosis (active or inactive form).
6. covid positve
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the PEF1 |
weeks 1, 4, 8 and 12. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in FEV1 value |
2 hours after the inhalation of the study/reference product. |
| Evolution of the PEF value |
as measured at Visits 2, 3 and 4. |
| Changes of the index according to the ACQ-5 questionnaire for evaluation of BA control |
from baseline. |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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) is a heterogeneous disease,
characterized by chronic inflammation of the respiratory tract, and accompanied
by respiratory symptoms such as wheezing, dyspnea, chest congestion and cough.
These signs vary in duration and intensity and manifest along with variable
airway obstruction.
Today,
BA is a global health problem. According to the World Health Organization
(WHO), approximately 235 million people worldwide suffer from BA, of which
about 250,000 people die each year. The Asmidine Spray under study is a film forming, polymeric, osmotic
liquid spray directed for the preventive treatment of asthmatic attacks. The
spray liquid forms a stable (4-6h) and absorbent film on the nasal surface
immediately after application. The film acts like a physical barrier against
external asthma triggering contaminants.
|