| CTRI Number |
CTRI/2026/02/104660 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Formoterol and fluticasone propionate twice daily versus vilanterol and fluticasone furoate fixed dose combination once daily in adult asthma patients |
|
Scientific Title of Study
|
To compare the effect of Formoterol and fluticasone propionate versus vilanterol and fluticasone furoate fixed dose combination in adult asthma patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukhdev Singh |
| Designation |
Junior resident |
| Affiliation |
Sri guru ramdas University of health sciences |
| Address |
Department of TB and respiratory diseases sri guru ramdas university of health ss vallah amritsar
Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9878857268 |
| Fax |
|
| Email |
ferozepuria13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B C Sarin |
| Designation |
Professor and head of department |
| Affiliation |
Sri Guru Ramdas University of health sciences |
| Address |
Department of TB and respiratory diseases Sri Guru Ramdas institute of health sciences and research amritsar 143501
Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9417425031 |
| Fax |
|
| Email |
bcsarin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B C Sarin |
| Designation |
Professor and head of department |
| Affiliation |
Sri Guru Ramdas University of health sciences |
| Address |
Department of TB and respiratory diseases Sri Guru Ramdas institute of health sciences and research amritsar 143501
Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9417425031 |
| Fax |
|
| Email |
bcsarin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ramdas University of health sciences vallah amritsar punjab 143501 |
|
|
Primary Sponsor
|
| Name |
Department of Chest and Tb Sri Guru Ramdas University of health sciences amritsar |
| Address |
Sri Guru Ramdas University of health sciences amritsar 143501 |
| Type of Sponsor |
Private medical college |
|
|
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 BC Sarin |
Sri guru ramdas University of health sciences |
Department of TB and respiratory diseases
Amritsar
PUNJAB |
9417425031
bcsarin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Formoterol fluticasone propionate fixed dose combination in adult asthma patients |
Formoterol 6 mcg and fluticasone propionate 250 mcg administered twice daily inhalation in adult asthma patients |
| Comparator Agent |
Vilanterol and fluticasone furoate fixed dose combination once daily in adult asthma patients |
Vilanterol 25 mcg and fluticasone furoate 200 mcg fixed dose combination administered once daily inhalation in adult asthma patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults greater than 18 years with the diagnosis of asthma as per GINA guidelines will be included in this study |
|
| ExclusionCriteria |
| Details |
Patients with unstable angina heart failure recent acute MI within 4 to 6 weeks suspected presence of active TB and other communicable respiratory diseases patients with respiratory failure patients with neurological musculoskeletal and peripheral vascular diseases patients with pneumonia and other respiratory illnesses limiting patients chest movements abdominal or thoracic aortic aneurysm active hemoptysis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical effect of Formoterol and fluticasone propionate versus vilanterol and fluticasone furoate fixed dose combination in adult asthma patients it aims to evaluate their impact on symptom control lung function |
At baseline at 2 weeks then at 4 weeks and then at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/03/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To compare the effect of Formoterol and fluticasone propionate twice daily versus vilanterol and fluticasone furoate once daily fixed dose combination in adult asthma patients Spirometry to be done at baseline and then at 2 4 8 weeks after initiation and this study will help to tind bettter inhaler combination in asthma patients |