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CTRI Number  CTRI/2012/09/002961 [Registered on: 05/09/2012] Trial Registered Prospectively
Last Modified On: 07/10/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A randomized, open labelled, multi centric parallel group three arms clinical study to evaluate the effifacy and safety of roflumilast 500mcg tablet in chronic obstructive pulmonary disorder.  
Scientific Title of Study   A phase 3 prospective, randomized, open labelled multicentric,parallel group, three arms clinical study to evaluate the efficacy and safety between monotherapy of Glenmarks Roflumilast 500mcg tablet and combination therapy of roflumilast 500mcg tablet plus tiotropium 9mcg inhalation and combination therapy of roflumilast 500mcg tablet plus salmeterol 25mcg inhalation in adult patients with chronic obstructive pulmonary disease 
Secondary IDs if Any  
Secondary ID  Identifier 
GGL-CT-08-11 Version 1.1 dated 2 May 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Sawant 
Designation  Senior Vice President - Clinical Research 
Affiliation  Glenmark Generics Ltd.India 
Address  Glenmark Generics Ltd., Clinical Research Unit, D-508, T.T.C. Industrial Area, Turbhe, Navi Mumbai
Glenmark House,B.D. Sawant Marg, Chakala, Off Western express highway, Andheri East 400099
Mumbai (Suburban)
MAHARASHTRA
400705
India 
Phone  02227611721  
Fax  02227680321  
Email  snikhil@glenmark-generics.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nikhil Sawant 
Designation  Senior Vice President - Clinical Research 
Affiliation  Glenmark Generics Ltd.India 
Address  Glenmark Generics Ltd., Clinical Research Unit, D-508, T.T.C. Industrial Area, Turbhe, Navi Mumbai
Glenmark House,B.D. Sawant Marg, Chakala, Off Western express highway, Andheri East 400099
Mumbai (Suburban)
MAHARASHTRA
400705
India 
Phone  02227611721  
Fax  02227680321  
Email  snikhil@glenmark-generics.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nikhil Sawant 
Designation  Senior Vice President - Clinical Research 
Affiliation  Glenmark Generics Ltd.India 
Address  Glenmark Generics Ltd., Clinical Research Unit, D-508, T.T.C. Industrial Area, Turbhe, Navi Mumbai
Glenmark House,B.D. Sawant Marg, Chakala, Off Western express highway, Andheri East 400099
Mumbai (Suburban)
MAHARASHTRA
400705
India 
Phone  02227611721  
Fax  02227680321  
Email  snikhil@glenmark-generics.com  
 
Source of Monetary or Material Support  
Glenmark House, B.D. Sawant Marg, Chakala, Off. Western Express Highway, Andheri East 400099  
 
Primary Sponsor  
Name  Glenmark Generics Limited  
Address  Glenmark House, B.D. Sawant Marg, Chakala, Off. Western Express Highway, Andheri East 400099  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Glenmark Generics Limited  7-D, Atmaram House, 1,Tolstoy Marg, New Delhi- 100 001 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Kumar  Asthma Bhawan  Consulting Chest Physician, Block No. R-3,Asthma Bhawan, Sector- 6, Opposite Cinestar Cinema Hall, Vidya Nagar, Jaipur- 302 023.
Jaipur
RAJASTHAN 
9314249227

drashish19@gmail.com 
Dr Jain Shailesh Jayantilal  Bhatia Hospital, Medical Research Society  Bhatia Hospital, medical Research Society, Tardeo Road, Mumbai-400007, Maharashtra, India
Mumbai
MAHARASHTRA 
09819266859

drshailesh_jain@yahoo.co.in 
Dr Surya Kant  C.S.M. Medical University  Professor & HOD of Pulmonary Medicine,C.S.M Medical University, Earlier King George Medical College, Lucknow 226003
Lucknow
UTTAR PRADESH 
9415016858

skantpulmed@gmail.com 
Dr Vinaya Karkhanis  Department Dept. Pulmonary Medicine  Department Dept. Pulmonary Medicine, OPD Bldg, 2nd Floor, BYL Nair Hospital, A L Nair Road, Mumbai Central (E), Mumbai- 400 008
Mumbai
MAHARASHTRA 
989227803

vinayadr@hotmail.com 
Dr Shubhangi Deshpande   Dept. Of Medcine, GMERS Medical College  GMERS Medical College, Gotri Main Road, (Old TB Hospital Campus), Vadodara-390021, Gujarat, India.
Vadodara
GUJARAT 
07878081208

shubhangi311@yahoo.com 
Dr Vinayakumar Mahisale  Dept. Of Respiratory, KLES Dr. Prabhakar Kore Hospital and Medical Research Center  Dept. Of Respiratry KLES Dr. Prabhakar Kore Hospital and Medical Research Center,Belgaum, Karnataka, India.
Belgaum
KARNATAKA 
09448920651

pulmovinay@yahoo.com 
Dr Sanjiv Walanj  Ethika Cinical Research center, Prakruti Hospital   Director,Siddheshwar Arcade, Near Manisha nagar gate no. 1, Kalwa Thane West
Thane
MAHARASHTRA 
02225386760

aparnaw@ethika.in 
Dr Hemant Manjarekar  Krishna Hospital  2, Anjanwel Prashant Society, Paud Road Kothrud, Pune-411038
Pune
MAHARASHTRA 
919822307660

hmanjarekar@yahoo.com 
Dr Alok Ghoshal  National Allergy Asthma Bronchitis Institute  Consultant Pulmonologist & Medical Director NAABI , OPD Room,National Allergy Asthma Bronchitis Institute 11/3, Dr.Biresh Guha Street, 2nd Floor, IMA House Park Circus, Kolkata - 700017
Kolkata
WEST BENGAL 
9830330404

agghoshal@yahoo.com 
Dr D N Hambire  Nobel Hospital  Nobel Hospital, 152, Magarpatta City Road, Pune- 411013
Pune
MAHARASHTRA 
9370194654

dhambire@gmail.com 
Dr Mukund Penurkar  Sanjeevan Hospital  Plot No 23, Off Karve Road Erandwane Pune-411004
Pune
MAHARASHTRA 
919923474811

mukund.penurkar@gmail.com 
Dr Sudhir Mundle  Shashwat Hospital   22, Happy Colony, Kothrud, Pune 411038
Pune
MAHARASHTRA 
919823074697

mundale2396@gmail.com 
Dr Govind Kulkarni  Shree Hospital  Pune-Nagar Road, Agakhan Palace, Pune-411006
Pune
MAHARASHTRA 
919822081168

drgdk2001@yahoo.co.uk 
Dr Harjit S Dumra  Sparsh Hospital  Consultant , Pulmonolgy Department, Ashrai Associates, Sparsh Hospital, 100 B , Swastik society, opp samved hospital, stadium commerce road, navrangpura, Ahmedabad
Ahmadabad
GUJARAT 
9825023160

drdumra@yahoo.co.in 
Dr K Srikanth  Sri Bala Medical Centre  Consultant Pulmonologist,Pulmonology department ,Room No. 115,Sri bala Medical Centre and Hospital, 901 Trichy Road Ramanathapuram Coimbatore
Ramanathapuram
TAMIL NADU 
9894257706

drsrikanthcbe@yahoo.com 
Dr Jitendra Agrawal  Surya Hospital  1117, Kasaba Peth, Pune-411011
Pune
MAHARASHTRA 
919890025762

jka29405@gmail.com 
Dr Sanglikar  Vedant Hospital  Consultant, Block No. S-3, Second Floor, Vedant commercial complex, Vartak nagar, Thane West
Thane
MAHARASHTRA 
9892078562

drraavindra@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Ehtics Committe Shahswat Hospital for Dr. Hemant Manjarekar  Approved 
Ehtics Committee Shashwat Hospital For Dr. Sudhir Mundle  Approved 
ETHICOS Independent Ethics Committee, Thane, Dr. Ravindra Sanglikar ; Dr. Sanjiv Walanj  Approved 
Ethics Committee KLE University for Dr. Vianay Kumar Mahisale  Approved 
Ethics Committee of Shree Hospital for Dr. Govind Kulkarni  Approved 
Ethics Committee Sanjeevan Hospital for Dr. mukund Penurkar  Approved 
Independent Research Ethics Committee for Dr. Jitendra Agrawal  Approved 
Instituitional Ethics Committee Topiwala National Medical College and B.Y.L. Nair Ch. Hospital  Approved 
Institutional ethics committee National Allergy Asthma Bronchitis Institute, Kolkata, Dr A G Ghoshal  Approved 
Institutional ethics committee Sri Bala Medical Centre & Hospital, Coimbatore, Dr K Srikant  Approved 
Institutional Ethics Committee, C.S.M Medical University, Lucknow, Dr Surya Kant  Approved 
Instiutional Human Ethics Committee for Dr. Shubhangi Deshpande  Approved 
Medical Research Society Ethics Committee  Approved 
Noble Hospital Institutional Ethics Committee  Approved 
Sujalam Independant Ethics Committee,Ahmedabad, Dr Harjit Dumra  Approved 
Swasthya Kalyan Ethics Committee, Jaipur, Dr Ashish Kumar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Obstructive Pulmonary Disorder with mild, moderate and Severe Condition. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Roflumilast 500mcg tablet  Dose: 500 mcg tablet,once daily for 24 weeks,Route: Oral. Roflumilast is a PDE4 enzyme inhibitor. The drug is approved by US FDA and EMEA for use in Chronic Obstructive Pulmonary Disease. 
Comparator Agent  Salmeterol 25mcg inhaler  Dose: 25 mcg ( 2 inhalations of 25 mcg twice daily) total dose 100 mcg per day for 24 weeks, Route: Inhalation (pMDI). Salmeterol 25mcg inhaler plus Roflumilast 500mcg tablet is a treatment arm for the study 
Comparator Agent  Tiotropium 9mcg inhaler  Dose: 9 mcg ( 2 inhalations of 9 mcg once daily) total dose 18 mcg per day for 24 weeks, Route: Inhaltion (pMDI). Tiotropium 9mcg inhalation plus ROflumilast 500mcg tablet is the treatment arm for the study.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or Female patients.
2.Age ≥ 40 years and < 65 years.
3.Written Informed Consent
4.Patients diagnosed with COPD, confirmed by spirometry test at screening visit with the following lung function parameters -
•FEV1 (post-bronchodilator) between ≥ 30% and
< 80%
• FEV1/FVC ratio (post-bronchodilator) < 70%
5.Patients with background therapy for COPD like beta 2 adrenergic receptor agonists / muscarinic receptor antagonists / Xanthine class of drugs
6.Patients with background therapy of inhaled corticosteroids who on a stable dose since last 6 weeks without any COPD exacerbations requiring treatment with systemic corticosteroids and hospitalization; will continue to use the same dose of inhaled corticosteroids during the complete study period.
7.Patients who are on ongoing concomitant therapy of Salbutamol inhaler will continue the medication through out the study period on SOS basis (i.e. up to 8 inhalations / day with a dose of 100mcg / inhalation). Salbutmaol inhalation therapy will be added for use as rescue medication on SOS basis to those patients who do not have prescribed Salbutamol inhalation therapy.
8.Current smokers with a smoking history of < 10 pack years or ex-smokers (smoking cessation at least one year ago)
9. Females of child bearing age must have a negative urine pregnancy test recorded at the screening visit, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study and at least 1 weeks post treatment if they are sexually active
 
 
ExclusionCriteria 
Details  1.COPD exacerbation indicated by a treatment with systemic corticosteroids and/or antibiotics not stopped within 4 weeks prior to screening visit and remains uncontrolled in between the treatment periods.
2.Diagnosis of asthma and/or other relevant lung disease.
3.Suffering from any concomitant disease that might interfere with study procedures or evaluation.
4.Lower respiratory tract infection not resolved 4 weeks prior to the screening visit.
5.Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/ECG) that are not related to COPD and that require further evaluation.
6.Known infection with HIV, active hepatitis and/or liver insufficiency.
7.Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start.
8.Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial.
9.Participation in another study (use of investigational product) within 30 days preceding the screening visit or re-entry of patients already enrolled in this trial.
10.Suspected inability or unwillingness to comply with study procedures.
11.Alcoholic or having drug abuse.
12.Inability to follow study procedures due to, for example, language problems or psychological disorders.
13.Use of prohibited medications like systemic corticosteroids, short acting beta 2 adrenergic receptor agonist except Salbutamol, long acting beta 2 adrenergic receptor agonist except Salmeterol, short or long-acting muscarinic antagonist except tiotropium, any other fixed dose combinations of inhaled medicines used for COPD and Xanthine class of drugs post randomization visit throughout the study period.
14.Suspected hypersensitivity to the study medication and/or contraindication to any ingredients of the study medication (roflumilast/ salmeterol/ tiotropium) or salbutamol rescue medication.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The mean change in pre bronchodilator Forced Expiratory Volume in 1 second (FEV1) [as measured in the clinic/hospital by trained personnel] between the treatment arms from the baseline visit at the End of study (Week 24) and mean change in reduction of COPD exacerbations between the treatment arms from baseline visit at each post randomization visit [as measured from the patient dairy data in the clinic/hospital by trained personnel].  FEV1 at baseline visit 1 and at week 24 (end of study) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in Mean Forced Vital Capacity from randomization visit to each post randomization study visit during the treatment period obtained by the spirometry test.
2.Changes in Mean FEV1/ FVC ratio from randomization visit to each post randomization study visit during the treatment period obtained by the spirometry test. 
Visit 1, 2,3, 4, 5, 6, 7, 8, 9. 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/10/2012 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Brief Summary  

A Phase 3, Prospective, randomized open labelled multicentric parallel group three arms clinical study to evaluate the efficacy and safety between monotherapy of GLenmark’s Roflumilast 500mcg tablet and combination therapy of ROflumilast 500mcg tablet plus Salmeterol 25mcg inhalation in Adults patients with Chronic Obstructive Pulmonary Disorder.

The Primary outcome measure is to assess the efficacy and safety between the monotherapy of ROflumilast 500mcg tablet tablet and combination therapy of ROflumilast 500mcg tablet plus salmeterol 25mcg inhalation in Adult patents with Chronic Obstructive Pulmonary Disorder.

 
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