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CTRI Number  CTRI/2015/04/005676 [Registered on: 07/04/2015] Trial Registered Retrospectively
Last Modified On: 24/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Fenspiride in the treatment of Asthma 
Scientific Title of Study   A multi-centric, placebo controlled, randomized, double-blind clinical trial to evaluate the efficacy and safety of Fenspiride in treatment of moderate persistent asthma as an add on therapy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ZUV/FENS/MPA-02/2012 version 01 date May 02, 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhupesh Dewan 
Designation  Director Medical Services 
Affiliation  Zuventus Healthcare Ltd 
Address  Office no 5119 D Wing 5th floor Oberoi Garden Chandivali Andheri East

Mumbai (Suburban)
MAHARASHTRA
400 072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhupesh Dewan 
Designation  Director Medical Services 
Affiliation  Zuventus Healthcare Ltd 
Address  Office no 5119 D Wing 5th floor Oberoi Garden Chandivali Andheri East


MAHARASHTRA
400 072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhupesh Dewan 
Designation  Director Medical Services 
Affiliation  Zuventus Healthcare Ltd 
Address  Office no 5119 D Wing 5th floor Oberoi Garden Chandivali Andheri East


MAHARASHTRA
400 072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Source of Monetary or Material Support  
Zuventus Healthcare Limited 
 
Primary Sponsor  
Name  Zuventus Healthcare Ltd 
Address  Office No 5119 D Wing 5th floor Oberoi Garden Estates Mumbai 400072 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santosh Kumar  King George’s Medical University  King George’s Medical University Chowk, Lucknow-226003, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 9415518345

skumarchest@yahoo.com 
Dr Neelkanth Awad  Lokmanya Tilak Muncipal Medical College and General Hospital, Sion  Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, College Building first floor room no. 14, Department of Respiratory Disease Dr. Babasaheb Ambedkar Road, Sion Mumbai
Mumbai
MAHARASHTRA 		 9322252708

nta1960@gmail.com 
Dr Soumya Das  Nightingale Hospital Multi-Speciality Clinic  Nightingale Hospital Multi-Speciality Clinic 11, Shakespeare Sarani, Kolkata, West Bengal 700071
Kolkata
WEST BENGAL 		 9830165956

drsoumya94@gmail.com 
Dr P ThirupathiRao  Rajiv Gandhi Institute of Medical Sciences & RIMS Govt General Hospital  Rajiv Gandhi Institute of Medical Sciences, Department of pulmonary Hudco Colony, Balaga, Srikakulam,532001 Andhra Pradesh
Srikakulam
ANDHRA PRADESH 		 8942279033

rimsresearch@gmail.com 
Dr Manish Jain  S R Kalla Memorial Gastro and General Hospital   S R Kalla Memorial Gastro and General Hospital , 78-79, Sardar Patel Marg, C Scheme, Jaipur - 302001
Jaipur
RAJASTHAN 		 9414414834

doctormanishjain2@gmail.com 
Dr Monica Gupta  Samvedna Hospital  Samvedna Hospital, Pulmonary department B27/88G, Ravindrapuri, Bhelupura, Varanasi - 221010
Lucknow
UTTAR PRADESH 		 09415336322

monicag4@yahoo.com 
Dr Aruna Vasireddy  Siddhartha Medical College & Government General Hospital  Government Siddhartha Medical College Campus, Ring road, Gunadala, Vijayawada, Andhra Pradesh 520008
Krishna
ANDHRA PRADESH 		 9985404458

vasireddyaruna@rediffmail.com 
Dr George Albert Dsouza   St. John’s Medical College Hospital   St. John’s Medical College Hospital, Division of Chest medicine, Sarjapur Road, Bangalore – 560034, India
Bangalore
KARNATAKA 		 09343701390

dsouza.ga@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Tilak Municipal Medical College   Approved 
Institutional Ethics Committee RIMS Hospital  Approved 
Institutional Ethics Committee, King Georges Medical College  Approved 
Institutional Ethics Committee, Nightingale Hospital  Approved 
Institutional Ethics Committee, Siddhartha Medical College and Government General Hospital  Approved 
SR Kalla Memorial Ethics Committee  Approved 
St John’s Medical College & Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Budesonide 200 µg and Fenspiride 80 mg  Budesonide 200 µg b.i.d for one week Budesonide 200 µg b.i.d and Fenspiride 80mg t.i.d for 2 weeks 
Comparator Agent  Budesonide 200 µg and Placebo   Budesonide 200 µg b.i.d for one week Budesonide 200 µg b.i.d and Placebo t.i.d for 2 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participant Inclusion Criteria
1.Male or female patients aged 18 years or older.
2.Diagnosed of moderate persistent asthma which is characterized by a forced expiratory volume in 1 second (FEV1) within prediction of 60 % to 80%.
3.Reversibility in the measurement of peak expiratory flow rate (PEFR)
4.FEV1 > 12% after inhalation of 400 µg salbutamol, and current therapy with inhaled corticosteroid (budesonide 400 µg/day)
5.Ability to perform Spirometry.
6.Patients willing to give written informed consent and willing to comply with trial protocol.  
 
ExclusionCriteria 
Details  Participant Exclusion Criteria
1.History of other significant respiratory disease or hospitalization due to asthma within 3 months prior to enrollment in the study
2.History of smoking during 6 months preceding enrollment
3.Use of long acting anti histamines, aspirin, barbiturates, analgesics, opioid analgesics, tranquilizers, MAO inhibitors, long acting β2 agonist and alcohol during a week before enrollment in the study
4.Evidences of pulmonary infection on chest radiograph
5.Pregnancy or lactation
6.Any other clinically significant medical condition that may endanger the safety of participant or jeopardize the protocol.
7.Illness severe enough to require hospitalization
8.History of allergy to Fenspiride or similar compounds
9.Current or a History of Cancer.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome
•Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study
 		 Primary Outcome
•Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome
•Improvement in the Lung function parameters at the end of the study (mean change from the baseline)
•Decrease in the use of short acting β2 agonist at the end of the treatment phase.
•Assessment of therapy by investigator and patients at the end of the treatment period.
•Adverse events reported by the patients during the treatment period.
 		 within 14 days of treatment duration 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/01/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Title:

A multi-centric, placebo controlled, randomized, double-blind clinical trial to evaluate the efficacy and safety of Fenspiride in treatment of moderate persistent asthma as an add on therapy.

Study Phase:
 Phase III

Objectives:

 

The aim of this clinical study is to investigate the efficacy and safety of a 2 week treatment with fenspiride for therapy of moderate persistent asthma in adult patients receiving regular inhaled corticosteroid.

Primary Objective

The primary objective is to assess the efficacy of fenspiride in resolution of the clinical symptoms in patients with moderate persistent asthma receiving regular inhaled corticosteroid.

Secondary Objective

The secondary objectives of this trial include :

1.         To assess the efficacy of fenspiride in improvement of pulmonary parameters in patients with moderate persistent asthma.

2.         To evaluate the safety of the investigational drug

Study Design:

Prospective, Multi-centric, Randomized, Double Blind, placebo controlled, parallel-group study

Estimated Sample Size: 120

Study endpoints:

Primary Outcome

The primary outcomes in the study include:

  • Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study

Secondary Outcome

The various secondary outcomes of this study include

  • Improvement in the Lung function parameters at the end of the study (mean change from the baseline)
  • Decrease in the use of short acting β2 agonist at the end of the treatment phase.
  • Assessment of therapy by investigator and patients at the end of the treatment period.
  • Adverse events reported by the patients during the treatment period.

Test Product :

Fenspiride (80 mg)

Comparator:

Placebo

 
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