FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/04/107503 [Registered on: 02/04/2026] Trial Registered Prospectively
Last Modified On: 07/08/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to evaluate the outcome of Once-Daily Vilanterol/Fluticasone Furoate with Twice-Daily Formoterol/Budesonide Inhalers in Participant with Uncontrolled Asthma. 
Scientific Title of Study   Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Once-Daily Vilanterol / FluticaSone Furoate (Vi/FF) versus TWIce-Daily FormoTerol/Budesonide (For/Bud) MART in Patients with UnControlled AstHma: V-SWITCH study 
Trial Acronym  V-SWITCH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIS/2026/08 Version 1.0 Dated 09-Mar-2026   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumit Bhushan 
Designation  Deputy general Manager-Clinical Studies Global Medical Affairs  
Affiliation  Glenmark Pharmaceuticals ltd. 
Address  Glenmark Pharmaceuticals Ltd., Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri East, Mumbai, (Suburban) MAHARASHTRA 400099 India

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  08800352225  
Fax    
Email  Sumit.Bhushan@glenmarkpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumit Bhushan 
Designation  Deputy general Manager-Clinical Studies Global Medical Affairs  
Affiliation  Glenmark Pharmaceuticals ltd. 
Address  Glenmark Pharmaceuticals Ltd., Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri East, Mumbai, (Suburban) MAHARASHTRA 400099 India


MAHARASHTRA
400099
India 
Phone  08800352225  
Fax    
Email  Sumit.Bhushan@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical Operations 
Affiliation  Clinical Research Network India Pvt Ltd 
Address  B-806,807, Advant Navis Business Park #Plot #7, Noida-Greater Noida Expressway Sector 142, Noida, Delhi-NCR, Gautam Buddha Nagar UTTAR PRADESH 201305 India

Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  9695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd. Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri (E), Mumbai – 400099 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd. 
Address  Glenmark Pharmaceuticals Ltd., Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri East Mumbai (Suburban) MAHARASHTRA 400099 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Clinical Research Network India Pvt Ltd  B-806 & 807, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi-NCR, Uttar Pradesh 201305 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deependra Kumar Rai  All India Institute of Medical Sciences  Dept. of Pulmonary Medicine, All India Institute of Medical Sciences, Patna Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507, India.
Patna
BIHAR 		 7764981421

drdeependrak@aiimspatna.org 
Dr Sushant Hiraman Meshram  Asian KHMC Multispeciality Hospital  213, West High Court Road, Shankar Nagar Square, Dharampeth, Nagpur, Maharashtra 440010
Nagpur
MAHARASHTRA 		 9860990379

drsushant.in@gmail.com 
Dr Anjali R Nath  Citizen Hospital  Department of Respiratory Medicine #14, 2nd Main, Dispensary Road, Kalasipalya, Bangalore, 560002
Bangalore
KARNATAKA 		 9995395041

anjali.madh@gmail.com 
Dr Jitendra Singh Kushwaha  Prakhar Hospital Pvt. Ltd.  Department of medicine, 8/219, Arya Nagar, Kanpur, Uttar Pradesh, 208002
Kanpur Nagar
UTTAR PRADESH 		 9415040752

dr.jskushwahacr@gmail.com 
Dr Krishna Prasad Anne  Pranaam Hospital  Department of Medicine; Ground floor, 1-56/6/40 & 41, Ramakrishna Nagar, Mythri Nagar, Madeenaguda , Hyderabad, Telangana 500050
Hyderabad
TELANGANA 		 9481149281

krishnaprasadanne@gmail.com 
Dr Vijaykumar Barge  Rajarshee Chattrapati Shahu Maharaj Government Medical College and CPR Hospital  Department of medicine, Room No 07; CPR Hospital Dasara Chowk, Bhausinghaji Road, Kolhapur, Townhall 416012, Maharashtra India Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA 		 7969792775

drvijaybarge12@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Citizen Hospital Inst. Ethics Committee  Submittted/Under Review 
Ethics Committee GSVM Medical College, Kanpur  Approved 
IEC Prakhar Hospital Pvt Ltd  Submittted/Under Review 
IEC-AIIMS-P ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE PRANAAM HOSPITALS  Submittted/Under Review 
Institutional Ethics Committee,AKHMC,Nagpur  Submittted/Under Review 
RCSMGMCIEC2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J455||Severe persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Formoterol 6 mcg + Budesonide 400 mcg Dry Powder Inhaler  Dose- Twice daily inhalation (In Capsule) Duration: 24 Weeks  
Intervention  Vilanterol 25 mcg + Fluticasone Furoate 200 mcg Dry Powder Inhaler   Dose- Once daily inhalation (In Capsule) Duration: 24 Weeks  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients aged greater than or equal to 12 years with documented diagnosis of asthma and uncontrolled on low dose of For/Bud (200 µg BD MART).
2. Pre-bronchodilator FEV1 of 40-90% predicted normal.
3. ACQ-5 score greater than or equal to 1.5 at baseline.
4. Patient or parent guardian willing to give a written informed consent/parental consent or assent form.
5. Able to or Willing to strictly adhere to investigator’s prescription  
 
ExclusionCriteria 
Details  1. Current hospitalization with life threatening condition or patients with acute
exacerbation of asthma (acute condition).
2. Patients who have used medium dose Formoterol/Budesonide (6/400 µg DPI) (MART)
in the past.
3. Patients already on high dose For/Bud (greater than 800 µg)
4. Patients with COPD
5. Women of childbearing potential are not restricted in this study, however it is expected
that the investigator will assess the risks and benefits of the assigned treatment as per
the product label(s) and discuss this with any women of childbearing potential prior to
providing the patient with the prescription for the assigned treatment.
6. Patients who have participated in any clinical trial within 30 days prior to enrolment
and would not be participating in clinical study during the period of study participation
7. History of known hypersensitivity to any individual study drug of the study drug
combination or to any of the excipient present in the dosage form. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare improvement in asthma control over 24 weeks as assessed by change from baseline in Asthma Control Questionnaire (ACQ-5) score in patients receiving once-daily Vilanterol / Fluticasone DPI vs twice-daily Formoterol/ Budesonide DPI.   over 24 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Efficacy endpoints

a. To compare changes in lung function parameters FEV1
b. To compare FEV1
c. Proportion of patients with asthma exacerbations during the treatment period
d. Proportion of patients requiring hospitalization or exacerbation related medical visits
e. Rescue medication use averaged
f. To assess Reliever Free days over treatment
g. To assess Asthma Control Day over treatment defined as day and night with no asthma symptoms no reliever medication use and no nighttime awakening due to asthma
h. To assess nighttime awakenings
i. To assess treatment compliance
j. Assessment of patient satisfaction with the treatment
k. Assessment of physician satisfaction with the treatment
 		 From baseline to 24 weeks
FEV1 2 hours post dose at baseline
Over 24 weeks of treatment 
Secondary Safety Endpoints
a. Number of patients with any drug related treatment emergent adverse events.
b. Number of patients with TEAE
c. Number of patients with serious TEAEs.  		 up to Week 24 
Exploratory Endpoints

a. Proportion of patients achieving clinical remission  		 At Week 24  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/04/2026 
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="0"
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  

This will be a randomized, open-label, comparative study to evaluate the Efficacy and Safety of Vilanterol/ Fluticasone versus Formoterol/ Budesonide (For/Bud) in Patients with Uncontrolled Asthma. Patients aged greater than equal to 12 years will be enrolled in the study. They would be randomized in a 1 is to 1 ratio to receive either study drug or comparator. Study duration for each subject will be 24 weeks. Physical examination, Vitals, Spirometry, ACQ-5, AE, SAE assessments will be performed at all study visits. Concomitant medications will also be recorded at all visits.


 
Close