FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066334 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Comparison of inhalational new drug vilanterol fluticasone furoate combination with salmeterol fluticasone furoate combination for reversible respiratory obstructive disease. 
Scientific Title of Study   A randomized controlled trial to compare safety and efficacy of inhalational long acting β2 agonist Vilanterol with fluticasone furoate against Salmeterol with fluticasone furoate in adult patients with reversible obstructive airway disease. 
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 Chandra Dhar Shukla 
Designation  JR1 PG Pharmacology 
Affiliation  Bharati Vidyapeeth (DTU) Medical College Pune  
Address  Department of Pharmacology Bharati Vidyapeeth Deemed To Be University, Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  7007422748  
Fax    
Email  chandradhar.shukla2010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayshree Shriram Dawane  
Designation  Professor 
Affiliation  Bharati Vidyapeeth DTU Pune 
Address  Department of Pharmacology 1st floor Medical college building Bharati Vidyapeeth Deemed To Be University Medical College Dhankawadi Pune Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9850817154  
Fax    
Email  jayshree.dawane@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Jayshree Shriram Dawane  
Designation  Professor 
Affiliation  Bharati Vidyapeeth DTU Pune 
Address  Department of Pharmacology 1st floor Medical College Building Bharati Vidyapeeth Deemed To Be University Medical College Dhankawadi Pune Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9850817154  
Fax    
Email  jayshree.dawane@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Both the inhalational drugs vilanterol with fluticasone furoate combination and salmeterol with fluticasone furoate combination will be provided by Bharati Vidyapeeth Deemed To Be University Medical College, Dhankawadi Pune Maharashtra 411043. 
 
Primary Sponsor  
Name  Central Research And Publication Unit  
Address  Bharati Vidyapeeth Deemed To Be University Medical College Dhankawadi Pune Maharashtra 411043 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandra Dhar Shukla  Bharati Vidyapeeth (Deemed To Be) Medical College Pune  Bharati Vidyapeeth (Deemed To Be) Medical College Pune Maharashtra 411043
Pune
MAHARASHTRA 		 7007422748

chandra.dhar-mcp@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Bharati Vidyapeeth Deemed To Be University Medical College Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.Vilanterol with Fluticasone Furoate 2.Salmeterol with Fluticasone Furoate  1.Vilanterol with Fluticasone Furoate OD for 4 weeks 2.Salmeterol with Fluticasone Furoate BD for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age: 18 – 60 years of age.
Clinically diagnosed patients of chronic obstructive airway disease with FEV 1 between 40% to 85% of the predicted normal value.
 
 
ExclusionCriteria 
Details  Acute exacerbations of asthma. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare efficacy of once daily VI/FF against twice daily SAL/FF in adult patients with chronic obstructive airway disease.  At Baseline then at 7 days and then at end of 4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the safety & tolerability of FF/VI compared to FP/SAL by analyzing adverse events, serious adverse events during 4 weeks.

2.To investigate the impact of FF/VI vs. FP/SAL on health outcomes, such as Asthma Quality of Life
 		 At beginning then after 7 days & finally at the end of 4 weeks. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   06/05/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 research basically addresses the pressing need for optimized treatment strategies amidst increasing respiratory ailments. This is a comparative study between inhalational long acting β2 agonist Vilanterol with fluticasone furoate against Salmeterol with fluticasone furoate for safety and efficacy. Out of the two Vilanterol being once a daily drug has better adherence to regimen and so we developed the proforma for obtaining the information regarding the safety and efficacy of the drugs in adult patients at the end of 18 months study period. Adult patients (age group 18-60 year) suffering from reversible obstructive airway disease would be selected from pulmonary medicine department of a tertiary care center and would be divided into two groups of 35 patients each and one group will receive Vilanterol with fluticasone furoate while the other will receive Salmeterol with fluticasone furoate and they will be accessed for changes in FEV1 and FVC values , severity  and numbers of respiratory distress and AQI thrice at beginning, at 7 day interval and finally at 4 week interval. 
Close