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CTRI Number  CTRI/2012/02/002405 [Registered on: 06/02/2012] Trial Registered Prospectively
Last Modified On: 07/06/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Fixed Dose Combinations of Fluticasone Plus Formoterol in patients with Asthma. 
Scientific Title of Study   A phase III, randomized, open label, non-inferiority, comparative, parallel group, multicentric study between fixed dose combinations of Fluticasone 250 μg Plus Formoterol 12 μg as DPI (capsules) (test drug) and Fluticasone 250 μg (Fluticaps 250 μg) plus Formoterol 12 μg (Foradil 12 μg) delivered via separate DPI’s in a 12-week treatment period of adolescent and adult subjects with moderate-severe persistent asthma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GPL-CT/2011/010/III; Version 1.0, dated 08.09.2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Avhad 
Designation  Sr. Manager - Medical Services 
Affiliation  Glenmark Pharmaceuticals Ltd. 
Address  Glenmark Pharmaceuticals Ltd. Glenmark House, BD Sawant Marg, Chakala Andheri East, Mumbai

Mumbai
MAHARASHTRA
400099
India 
Phone  912240189999  
Fax    
Email  anilavhad@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailendra Sachan 
Designation  Manager-Clinical Research 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark Research Centre, Plot No. A-607, T.T.C. Industrial Area, MIDC, Mahape, Navi Mumbai

Thane
MAHARASHTRA
400709
India 
Phone  912267720000  
Fax    
Email  shailendrasachan@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd. 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri(East), Mumbai, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V Nagaeshwar   Aswini Hospital  Dept of Pulmonology Opp Andhra Bank , Nakkallagutta Hanamkonda, Warangal
Warangal
ANDHRA PRADESH 		 9949529392

doctor4lungs@gmail.com 
Dr K N Poddar  Chest Asthma and Allergy Clinic  91, Vivekanand Road, Rirish Park
Kolkata
WEST BENGAL 		 9831013612

drknpoddar@yahoo.com 
Dr Nandagopal   Karthick Poly Clinic  101/67 Karunanidhi Nagar, Behind Sungam Chinthamani, Trichy Road, Ramanathapuram
Coimbatore
TAMIL NADU 		 9842780383

dr_nanda@yahoo.com 
Dr Rajesh Kumar Gupta  Mahatma Gandhi Medical College & Hospital   Dept. of Medicine, MGMCH, RIICO, Institutional Area, Sitapura
Jaipur
RAJASTHAN 		 01412770064

devee30@rediffmail.com 
Dr Balram Ghosh   Medical College , Kolkata  Department of Clinical Pharmacology 88, College street, Govt. of W. B. Kolkata
Kolkata
WEST BENGAL 		 9432876733

drbrghosh@gmail.com 
Dr Aloke Ghoshal   National Allergy Asthma Bronchitis Institute  11/3 Dr. Biresh Guha Street 2nd Floor, IMA House
Kolkata
WEST BENGAL 		 98300680023

agghosal@yahoo.com 
Dr Hirennappa   Pace Clinical Research  A Unit of Pranav Diabetes Center, 57/1, Nandha Complex, Banaswadi, R.M. Nagar
Bangalore
KARNATAKA 		 08041626643

hudnur@yahoo.co.in 
DrManish Kumar Jain   Shwass Center, Navkar Hospital  G-11, Shubham Apartment, Central Spine, Vidhyadhar Nagar
Jaipur
RAJASTHAN 		 9414414834

doctor_manish2003@yahoo.co.in 
Dr Parth N Patel  St. Theresas Hospital  Dept. of Medicine Sanath Nagar, Hyderabad
Hyderabad
ANDHRA PRADESH 		 9391036456

parthnp@yahoo.com 
Dr Sivakumar   Sudha Lung Care and Research Centre  No.5, SKS Clinic, Ramani Complex, Opposite New Bus Stand, Salem
Salem
TAMIL NADU 		 9842803047

pulmondrsiva@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Clinicom, Bangalore_Aswini Hospital, Waranagal   Approved 
Clinicom, Bangalore_Chest Asthma and Allergy Clinic, Kolkata   Approved 
Clinicom, Bangalore_Karthick Poly Clinic, Coimbatore  Approved 
Clinicom, Bangalore_Pace Clinical Research, Bangalore   Approved 
Clinicom, Bangalore_Shwass Center, Navkar Hospital, Jaipur  Approved 
Clinicom, Bangalore_St. Theresas Hospital, Hyderabad   Approved 
Clinicom, Bangalore_Sudha Lung Care and Research Centre, Chennai   Approved 
Institutional Ethics Committee_Mahatma Gandhi Medical College & Hospital , Jaipur   Approved 
Institutional Ethics Committee_Medical College, Kolkata  Approved 
Institutional Ethics Committee_National Allergy Asthma Bronchitis Institute, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed Dose Combinations of Fluticasone 250 μg Plus Formoterol 12 μg as DPI  1 puff twice daily for 12 weeks 
Comparator Agent  Fluticap 250 μg & Foradil 12 μg as separate DPIs  1 puff twice daily for 12 weeks 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. The patient and/or legally accepted representative (LAR) provides written informed consent to participate in the study.
2. Male or female patient aged between 16 to 70 years with known history of moderate-severe persistent, reversible asthma for ≥ 6 months.
3. FEV1 between ≥40% to < 80% of the predicted value.
4. Patient willing to perform all study related procedures including the use of study inhalers, spirometer and peak flow meter
5. Positive response to the reversibility test.
6. Females of child bearing age must have a negative pregnancy test at screening visit, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. 
 
ExclusionCriteria 
Details  1. Inability to carry out pulmonary function testing
2. Significant, non-reversible, active pulmonary disease
3. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
4. History of near fatal asthma within the past one year
5. Evidence of severe asthma exacerbation or upper or lower respiratory tract infections within the past 4 weeks
6. Active smoker
7. Subjects who are using any medication or have any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study
8. Clinically significant cardiovascular, haematological, endocrine, neurological, gastrointestinal, psychiatric, metabolic, immunologic, infectious, hepatic, renal, gynaecological disease or other condition that the investigator considers detrimental to the patient’s participation in the study or that may prevent the successful completion of the study
9. History of uncontrolled Diabetes mellitus
10. Clinically significant ECG Abnormality at baseline
11. Use of prohibited medication
12. Patients who received any investigational new drug within the last 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean difference between groups in FEV1 value at the End of Treatment Visit  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in morning PEF  12 weeks 
Change in asthma symptom score   12 weeks 
Number of asthma exacerbations  12 weeks 
Change in evening PEF  12 weeks 
Change in Diurnal variability of PEF  12 weeks 
Change in nocturnal asthma symptom   12 weeks 
Average need for use of short acting β 2 agonists  12 weeks 
 
Target Sample Size   Total Sample Size="372"
Sample Size from India="372" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   06/02/2012 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a randomized, open–label, comparative, non-Inferiority, multicenteric study. The study will be conducted in adolescent and adult patients with a diagnosis of Moderate-Severe Persistent Asthma with an FEV1 of ≥40% to < 80% of the predicted value. Study will enroll 372 patients across different centers from India.

Patients will be recruited after providing written informed consent. After screening and run in period, patient will be randomized (patient meeting randomization criteria) in 1:1 ratio to receive either FDC of Fluticasone 250 μg Plus Formoterol 12 μg as DPI (capsules)  or Fluticasone 250 μg (Fluticap 250 μg)  Plus Formoterol 12 μg (Foradil 12  μg) delivered via separate DPI’s.

The primary objective of the study is to evaluate the effect of study drug on lung function as assessed by FEV1 after the therapy (12 weeks). Secondary objective includes Change in PEF, asthma symptoms, number of asthma exacerbations, average need for use of short acting β 2 agonists and safety. Patients will be followed for safety and efficacy assessment at week 4, 8 and 12 after start of therapy. 
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