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
Trial Acronym
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
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
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
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" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.