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CTRI Number  CTRI/2012/11/003087 [Registered on: 06/11/2012] Trial Registered Prospectively
Last Modified On: 30/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To assess safety, efficacy and tolerability of Formoterol Budesonide nebulised formulation in comparison with Formoterol Budesonide pressurized meter dose formulation in COPD patients 
Scientific Title of Study   A randomized, open label, active-controlled, parallel group, multicenter 6 weeks study to determine safety, tolerability and efficacy of nebulised formulation of Formoterol Budesonide combination in comparison with pressurized meter dose formulation of Formoterol Budesonide combination in Chronic Obstructive Pulmonary Disease (COPD) patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CP/01/12  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sundeep Salvi 
Designation  Director 
Affiliation  Chest Research Foundation 
Address  Chest Research Foundation, Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune

Pune
MAHARASHTRA
411 014
India 
Phone  09921211000  
Fax    
Email  ssalvi@crfindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaideep Gogtay  
Designation  Head Medical Services 
Affiliation  Cipla Ltd. 
Address  Cipla Ltd. Bellasis Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400 008
India 
Phone  02223025412  
Fax  02225787855  
Email  jgogtay@cipla.com  
 
Details of Contact Person
Public Query  
Name  Mr Abhijit Vaidya 
Designation  Project Manager 
Affiliation  Cipla Ltd. 
Address  Cipla Ltd., 3rd Floor, Raj Plaza, LBS Marg, Vikhroli (West), Mumbai

Mumbai
MAHARASHTRA
400 083
India 
Phone  02225716085  
Fax    
Email  abhijit.vaidya@cipla.com  
 
Source of Monetary or Material Support  
Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone 02223082891 Fax 02225787855 
 
Primary Sponsor  
Name  Cipla Ltd 
Address  Bellasis Road, Mumbai Central, Mumbai, Phone: (022) 23082891 Fax: (022)25787855. 
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 = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hiren Pandya  AMC MET Medical College and L.G. Hospital  AMC MET Medical College and L.G. Hospital, Rambaug, Maninagar Ahmedabad – 380008
Ahmadabad
GUJARAT 		 09824030986
-
drhirenpandya@yahoo.com 
Dr Nagaraj Boyilla  Axon Hospital  AXON Hospitals,8-3-215, Srinivasanagar, Colony (West), S.R. Nagar, Ameerpet Main Road, Opp. ICICI Bank, Hyderabad - 500038, Andhra Pradesh
Hyderabad
ANDHRA PRADESH 		 9848883444
-
drnagaraj.b@gmail.com 
Dr Sundeep Salvi  Chest Research Foundation  Chest Research Foundation, Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune – 411 014
Pune
MAHARASHTRA 		 9921211000
-
ssalvi@crfindia.com 
Dr Sanjiv Walanj  Ethika Clinical Research Centre  Ethika Clinical Research Centre Siddeshwar Arcade, B-wing First Floor Behind Prakruti hospital Opp. Manisha Nagar, Gate no.1 Kalwa Thane(West)- 400065
Thane
MAHARASHTRA 		 09892721857
-
sanjiv_walanj@yahoo.com 
Dr Vivek Nangia  Fortis Flt Lt. Rajan Dhall Hospital  Fortis Flt Lt. Rajan Dhall Hospital, B-1, Aruna Asaf Ali Marg, Vasant Kunj, New Delhi-110070
New Delhi
DELHI 		 9810048885
-
viveknangia@gmail.com 
Dr Raja Dhar  Fortis Hospital  Fortis Hospital , #730, Anandapur, EM Bypass Road, Kolkata – 700107
Kolkata
WEST BENGAL 		 9831855512
-
docaardee@yahoo.com 
Dr Mohan Rao  M S Ramaiah Memorial Hospital  M S Ramaiah Memorial Hospital Department of Chest Medicine, New BEL Road, MSRIT Post, Bangalore - 560054
Bangalore
KARNATAKA 		 9845270973
-
kotnur.rao@gmail.com 
Dr Praveen Pandey  Max Super Speciality Hospital  Max Super Speciality Hospital , 108 A, Indraprastha Extension, Patparganj, Delhi-110092
East
DELHI 		 9811180335
-
pkpandey2005@gmail.com 
Dr Vikrant Deshmukh  Nagpur Chest Center  Nagpur Chest Center, 25, Amarjyoti Palace, Dhantoli, Nagpur 440012, Maharashtra, India
Nagpur
MAHARASHTRA 		 9561098334
-
vikrant9825@gmail.com 
Dr Aloke Gopal Ghoshal  National Allergy Asthma Bronchitis Institute  National Allergy Asthma Bronchitis Institute, 11/3 Dr. Biresh Guha Street, Park Circus, IMA House , 2nd Floor, Kolkata 700 017
Kolkata
WEST BENGAL 		 9830068023
-
agghosal@yahoo.com 
Dr Balkrishna Tayade  NKP Salve Institute of Medical Science & Lata Mangeshkar Hospital  NKP Salve Institute of Medical Science & Lata Mangeshkar Hospital, Digdoh Hill ,Hingna Road, Nagpur 440019.
Nagpur
MAHARASHTRA 		 9422118730
-
botayade123@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
AMC MET Ethics committee for Dr. Hiren Pandya  Approved 
Axon Hospitals Axon Institutional Ethics Committee, Hyderabad for Dr Boyilla  Approved 
Balaji Medical and Diagnostic Research Centre Ethics Committee Max Super Speciality Hospital for Dr Pandey  Approved 
Ethics Committee for Research for Dr Vivek Nangia  Approved 
Fortis Hospital Ethics Committee, Kolkata for Dr. Raja Dhar  Approved 
Independent Ethics Committee, Snehal Hospital, Thane- for Dr. Sanjiv Walanj  Approved 
Institutional Ethics Committee for Chest Research Foundation, Pune for Dr. Sundeep Salvi.  Approved 
Institutional Ethics Committee Global Hospitals and Health City Tamil Nadu for Dr. Vijil Rahulan  Approved 
Institutional Ethics Committee National Allergy Asthma Bronchitis Institute-Kolkata for Dr. A G Ghoshal.  Approved 
Institutional Ethics Committee NKP Salve Institute of Medical Sciences & Lata Mangeshkar Hospital, Nagpur for Dr. Tayade  Approved 
Nagpur Independent Ethics Committee for Nagpur Chest Center, Nagpur-Dr. Deshmukh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patient diagnosed with COPD,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Formoterol Budesonide pMDI (6 mcg /200 mcg) manfactured by Cipla  two puffs twice daily 
Intervention  Formoterol Budesonide Respules (20 mcg /1 mg) manfactured by Cipla  nebulization over 10 minutes twice daily 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patient and/or LAR willing to give a written informed consent.

2. Patient of either sex aged above 40 years.

3. Patient diagnosed with COPD as per GOLD guidelines (post
bronchodilator FEV1/FVC ratio < 0.70)

4. Patient with documented history of COPD for at least the past 6 months and who are on stable dose of COPD medication (monotherapy or combination) for at least 4 weeks prior to screening visit 1.

5. Post-bronchodilator FEV1 ≤50% of the predicted normal value (as per the European Community for Coal and Steel formula and applying the correction factor of 0.9) when not taking short-acting bronchodilator medication for the previous 6 hours, ICS+LABA atleast 24 hours, LABA+LAMA atleast 48 hours, LAMA atleast 48 hours prior to visit.

6. Current and ex-smoker with a smoking history of at least 10 pack-years for cigarette and equivalent for bidi smoking.

7. Patient able to use inhaler + Zerostat VT spacer and nebulizer in their respective groups
 
 
ExclusionCriteria 
Details  1. History of asthma or any chronic respiratory disease other than COPD.

2. Long term administration of supplemental oxygen (15 hours/day)

3. Hospitalization for pulmonary exacerbation within the past one month or as per Investigator’s discretion.

4. Life-threatening/unstable respiratory status, including upper respiratory tract infection, within the previous 4 weeks or lower respiratory tract infection, within the previous 12 weeks.

5. History of lung resection of more than one full lobe.

6. Severe unstable or uncontrolled cardiovascular disorder, other pulmonary

disease, clinically significant hematological, endocrine, electrolyte, renal or hepatic abnormality

7. Any clinically significant lab values as per investigators discretion.

8. Pregnant or lactating or planning to become pregnant

9. Have a known hypersensitivity to Investigational product or any of the excipients contained in study medicines.

10.Treatment with any investigational drug in last 30 days prior to screening visit 1. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in pre-bronchodilator FEV1 & FVC between both the groups  Mean change in pre-bronchodilator FEV1 & FVC between both the groups 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in post-bronchodilator FEV1 between both the groups  baseline to end of 6 weeks 
Change in post-bronchodilator FEV1  2 and 4 weeks 
Change in post-bronchodilator FVC  2 and 4 weeks 
Change in pre and post bronchodilator FEF25-75 between both the groups  baseline to end of 6 weeks 
Difference in use of number of puffs of rescue medication  During study period 
Change in COPD questionnaire at week 6 from baseline  During study period 
Incidence of adverse events  During study duration 
Incidence of drug related adverse events  During study duration 
Incidence of COPD requiring emergency attendance, treatment with oral steroid and hospitalization  During study duration 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="112" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/11/2012 
Date of Study Completion (India) 28/11/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published in any journal. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a 6 weeks phase IV multicenter study to determine safety, tolerability and efficacy of nebulised formulation of Formoterol Budesonide combination in comparison with pressurized meter dose formulation of Formoterol Budesonide combination in Chronic Obstructive Pulmonary Disease (COPD) patients.  120 Patients will be enrolled into the study from at least 10 participating centers in India.  From these 120 patients, 80 patients will be given Formoterol Budesonide nebulization therapy and 40 patients will be given Formoterol Budesonide pMDI for the duration of 6 weeks.The primary end point of the study is to determine mean change in pre-bronchodilator FEV1 & FVC between both the groups

from baseline to end of 6 weeks. Incidence of adverse events will be determined as safety endpoints. Incidence of COPD exacerbation requiring emergency attendance, treatment with oral steroid and hospitalization will also be observed.

 
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