| CTRI Number |
CTRI/2024/03/064848 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of vilanterol/Fluticasone furoate with Formoterol/Budesonide in the management of bronchial asthma |
|
Scientific Title of Study
|
A comparative study of Vilanterol/Fluticasone furoate with Formoterol/Budesonide in the management of stable bronchial asthma |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr .N .Nalini Jayanthi |
| Designation |
Professor and Head of Department of Respiratory Medicine |
| Affiliation |
SRM Medical college Hospital and Research Centre |
| Address |
Room no 23, c block 2nd floor,Department of Respiratory Medicine,SRM Medical College Hospital and Research Centre , Kattankulathur, Kanchipuram district ,Tamilnadu ,India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444226783 |
| Fax |
|
| Email |
nalinijayanthi59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagadeesan M |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Pharmacy ,SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice , SRM College of Pharmacy ,SRM Institute of Science and Technology , Kattankulathur ,Kanchipuram,Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7449277556 |
| Fax |
|
| Email |
jagadeem1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sundari V |
| Designation |
Student |
| Affiliation |
SRM College of Pharmacy ,SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy ,SRM Institute of Science and Technology ,Kattankulathur ,Kanchipuram ,Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9597212773 |
| Fax |
|
| Email |
sundariv2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Pharmacy,SRM Institute of Science and Technology ,Kattankulathur,Kanchipuram ,Tamilnadu ,603203 |
|
|
Primary Sponsor
|
| Name |
SRM College of Pharmacy |
| Address |
SRM Institute of Science and Technology ,Kattankulathur ,Kanchipuram , Tamilnadu 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Nalini Jayanthi |
SRM Medical College Hospital and Research Centre |
Room no ; 23 ,c block 2nd floor, Department of Respiratory Medicine , Kattankulathur ,Kanchipuram ,Tamilnadu ,603203
Kancheepuram
TAMIL NADU |
9444226783
nalinijayanthi59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Formoterol/Budesonide |
6/200 mcg BD for 3 months |
| Intervention |
vilanterol/fluticasone furoate |
25/100 mcg OD for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with stable bronchial asthma
2. patients who already receiving prescription with formoterol /budesonide |
|
| ExclusionCriteria |
| Details |
1. patients with asthma /copd overlap
2. patients with bronchiectasis
3. patients with allergic bronchopulmonary aspergillosis
4.history of smoking
5.pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the therapeutic effectiveness of Vilanterol/Fluticasone furoate with Formoterl/Budesonide by monitoring pulmonary function test (spirometry) FVC(L),%FVC,FEV1(L),%FEV1,FEV1/FVC,FEF25-75% |
In the initial ,patients FVC,%FVC ,FEV1,FEV1/FVC ,FEF25-75% will be evaluated ,mean changes in the parameters observed at 4th week,8th week ,12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life assessed by ACQ5 Questionnaire,ACT Scores & Adherence Barrier Survey |
6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
At present ,commonly used LABA ( long acting beta 2 agonist ) for asthma management require twice daily which is less convenient for patients and leads to reduced adherence with long term therapy whereas Vilanterol is a once daily therapy lead to improve adherence with long term therapy.Formoterol not highly selective in beta2 adrenoreceptor in lungs whereas vilanterol is highly selective for beta2 adrenoreceptor in lungs , in patients with asthma inhaled vilanterol produce significant increase in Forced Expiratory volume in 1s(FEV1). vilanterol /fluticasone furoate increase drug adherence to patients due to once daily administration. vilanterol/fluticasone cardioprotective |