| CTRI Number |
CTRI/2011/10/002054 [Registered on: 11/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
10/10/2011 |
| 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 study to compare the Safety and Efficacy of fixed dose combination containing montelukast and acebrophylline and montelukast alone in Patients Suffering From Chronic Asthma |
|
Scientific Title of Study
|
A Multicentric, Comparative Controlled, Open Label, Randomized, Parallel-Group, Phase III Study to Evaluate the Safety and Efficacy of FDC containing Montelukast plus Acebrophylline and Montelukast alone in Patients Suffering From Chronic Asthama |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 12/2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfDr Tapan Kumar Pal |
| Designation |
Director |
| Affiliation |
Jadavpur University |
| Address |
Bioequivalence Study Centre,
Dept. of Pharmaceutical Technology, Jadavpur University,
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830036297 |
| Fax |
03324146186 |
| Email |
tkpal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.(Dr.) Tapan Kumar Pal |
| Designation |
|
| Affiliation |
|
| Address |
Bioequivalence Study Centre,
Dept. of Pharmaceutical Technology, Jadavpur University,
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830036297 |
| Fax |
(033)24146186/6266 |
| Email |
tkpal12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanita Sabhait |
| Designation |
Manager |
| Affiliation |
|
| Address |
Bioocn Ltd., 20th KM, Electronic City, Hosur Road, Bangalore- 560100
Bangalore
KARNATAKA
560100
India |
| Phone |
08028082113 |
| Fax |
08028523423 |
| Email |
vanita.sabhahit@biocon.com |
|
|
Source of Monetary or Material Support
|
| Biocon Ltd. 20th km, Hosur Road, Electronics City, Bangalore 560100, Karnataka State, India |
| Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata-700032. |
|
|
Primary Sponsor
|
| Name |
Biocon Ltd |
| Address |
Biocon Ltd. 20th km, Hosur Road, Electronics City, Bangalore 560100, Karnataka State, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bioequivalence Study Centre |
Bioequivalence Study Centre, Dept. Of Pharmaceutical Technology, Jadavpur University, Kolkata-700032. |
| TAAB Biostudy Services |
TAAB Biostudy Services, 27, Central Road, Jadavpur, Kolkata-700032 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balaram Ghosh |
Apex Institute of Medical Sciences (A Unit of Apex Hospitex) & Neurosciences Pvt. Ltd. |
Apex Institute of Medical Sciences (A Unit of Apex Hospitex) & Neurosciences Pvt. Ltd.Survey Park,,Sammilani Park, Santoshpur,-700075
Kolkata
WEST BENGAL |
09432876733
drbrghosh@gmail.com |
| Dr. Arunava Biswas |
Calcutta National Medical College, |
Calcutta National Medical College,32, Gorachand Road-700014
Kolkata
WEST BENGAL |
09674328329
drabiswas@gmail.com |
| Dr. R. G. Bhagat |
Dr. Bhagat's Allergy- Asthma Clinic And Respiratory Care Centre, Pathik |
Dr. Bhagat's Allergy- Asthma Clinic And Respiratory Care Centre, Pathik,,Dashaporwad Society , Gajarawala Flats Lane, B/h. Paldi Bus Stand, Paldi ,-380007
Ahmadabad
GUJARAT |
(079) 26574746
rajpurvi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| COMSARTS (IEC) Committee for Safety & Rights of Trial Subjects (Dr. Arunava Biswas) |
Approved |
| COMSARTS (IEC) Committee for Safety & Rights of Trial Subjects (Dr. Balaram Ghosh) |
Approved |
| COMSARTS (IEC) Committee for Safety & Rights of Trial Subjects (Dr. R. G. Bhagat) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients Suffering From Chronic Asthama, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Montelukast 10mg |
Orally once daily in the evening for 28 Days |
| Intervention |
Montelukast 10mg + Acebrophylline 100mg |
Orally once daily in the evening for 28 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
i) Male and female patients in the age group of 18- 64 years.
ii) Patients clinically diagnosed as suffering from mild asthma as indicated by an FEV1 between 60 and 85% of predicted.
iii) Requiring inhaled ß2-agonists on an as-needed basis
iv) Stable asthma; there should have been no exacerbations or need for any other treatment for one month, and no hospitalizations for asthma should have occurred with-in 3 months of the pre study visit.
v) Nonsmokers for at least 1 yr (with a smoking history of no more than 10 pack-yrs)
vi) ACT score 19 [18,19]
vii) ACQ score 1.5 [20]
viii) Subjects or legal representatives willing to give informed consent.
ix) Patient must not have received any drug similar to active or comparator group within 2 weeks of commencement of the study.
x) Females of childbearing potential should have a negative pregnancy test at the pre study visit and should agree to use contraception during the study.
|
|
| ExclusionCriteria |
| Details |
i) History of hypersensitivity reaction or any specific groups.
ii) Presence of severe hepatic or renal disorders,
iii) Pregnancy or lactation
iv) Alcoholics and heavy smokers.
v) Patients on following medications: Anticonvulsant drugs, Rifampicin, Erythromycin /other macrolides, Ciprofloxacin (not ofloxacin) Cimetidine (not ranitidine).
vi) Patients on anti TB drugs and or diagnosed to be suffering from tuberculosis.
vii) Patients suffering from HIV infection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical improvements are the primary end-points and are defined as patients who has:
1.Improvement in pulmonary function test (FEV1 & FEV1/ FVC)
2.Improvement in Asthma Control Tests Score (Appendix IV)
3.Improvement in Asthma Control Questionnaires Score (Appendix V)
4.(Reduction in) Number of as-needed ß2-agonist puffs used
5.Percentage of unscheduled or emergency asthma-related (primary care) consultations during the study period |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2011 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 was a Multicentric, Randomized, Parallel-Group Study to compare the efficacy of FDC containing montelukast plus acebrophylline and montelukast alone in Patients Suffering From Chronic Asthama. This study was conducted at three centers in India. 200 patients has taken part in the study.Efficacy
results: Statistical analysis reveals that the test product is more efficacious
than the comparator.
Safety
results: No specific safety concern has emerged from the analysis of the safety
dataset submitted for the treatment groups. However, it should be remembered
that the FDC tablet is intended to be used in chronic asthma patients between
the age group of 18 to 64 years.
|