| CTRI Number |
CTRI/2010/091/000571 [Registered on: 01/06/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, sustained release and immediate release mucoregulator in patients with bronchial asthma. |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of a Sustained release vs. Immediate release Mucoregulator for the treatment of bronchial asthma: An open label, randomized, comparative, multi-centric trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| SUN/SUAC/0110 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Surendra Borgharkar |
| Designation |
|
| Affiliation |
|
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East,
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Surendra Borgharkar |
| Designation |
|
| Affiliation |
|
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East,
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Surendra Borgharkar |
| Designation |
|
| Affiliation |
|
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East,
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd. |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd. |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Raj Bhagat |
Dr. Bhagat?s Allergy- Asthama Clinic and Respiratory Care Centre |
??Pathik??B/h Paldi Bus Stand,Dashporwad Society, Paldi-380007
Ahmadabad
GUJARAT |
07926574746
rajpurvi@yahoo.com |
| Dr. V. S. Chandarana |
Kusum Medical Nursing Home |
Kalpana, Moti Tanki,-360001
|
02812445997
drvijaykusum@yahoo.co.in |
| Dr. Krutesh Shah |
Mahavir Hospital |
A/6, Kirannagar, Opp. Vrundavan Bus Stop,Waghodia Road-390019
Vadodara
GUJARAT |
02652511375
kruteshshah@hotmail.com |
| Dr. Rahul V. Pai |
Pai Clinic & Diagnostic Centre |
778/B-1, Abhinav Apartments,Next to Congress House, Shivajinagar-411005
Pune
MAHARASHTRA |
02027290815
pairahul73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs Independant Ethics Committee for Dr. Krutesh Shah |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Raj Bhagat |
Approved |
| COMSARTs Independant Ethics Committee for Dr. V. S. Chandarana |
Approved |
| COMSARTs Independant Ethics Committee for Dr. Rahul V. Pai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bronchial asthma , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Immediate Release Mucoregulator |
The recommended dose is one capsule BD for 14 days |
| Intervention |
Sustained Release Mucoregulator |
The recommended dose is one tablets OD for 14 days |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Male or female Patients aged between 18 and 65 years.
2. Patients with history of bronchial asthma and chronic obstructive pulmonary disease as defined by American Thoracic Society (ATS).
3. Baseline FEV1 50 ? 85% in patients either untreated or receiving e.g. short-acting bronchodilators.
4. No change in the asthma treatment 4 weeks prior to baseline period
5. Patients willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women and women of childbearing potential who are not using contraceptives.
2. Patients with infection of lower airways.
3. Patients with cancer, pulmonary tuberculosis, or acute infection, Myocardial infarction, low blood pressure.
4. Patients who were hospitalized for asthma within three month before the study.
5. Patients suffering from lung disease other than asthma and COPD.
6. Patients who had used systemic steroid prior to 4 week of baseline visit and who are taking long acting β-agonist, inhaled anticholinergics with in one month before study and cromolyn, nedocromil within two week before study.
7. Patients who were heavy smokers with > 10 pack-years.
8. Patients with any severe illness like liver insufficiency, active hepatitis, known infection with HIV etc.
9. Patients with history of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.
10. Patients with suspected hypersensitivity and/or contraindication to any ingredients of the study medication or rescue medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Average change from baseline to end of trial in Forced expiratory volume in one second(FEV1). |
Baseline Visit (day 0), week 2. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Average change from baseline to end of trial in Forced expiratory vital capacity.(FVC)
2. Evaluation of auscultatory pattern
3. Average change from baseline to end of study in Symptom score (with an ordinal rating scale) of
? Cough
? Difficulty in expectorating
? Dyspnea
? Cyanosis
4. Expectoration characteristic score
? Viscosity of sputum
? Characteristic of sputum
5. Evaluation CGI-S and CGI-I
|
1. Baseline Visit (day 0), week 2.
2. For CGI-I, at week 2 only. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/06/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label, comparative, multi-centre trial comparing the safety and efficacy of Sustained release mucoregulator and Immediate release mucoregulator for 2 weeks in 200 patients with bronchial asthma that will be conducted in four centers in India only. The primary outcome measures will be evaluation of Average change in Forced expiratory volume in one second from baseline to end of treatment. The secondary outcomes will be evaluation Average change from baseline to end of trial in Forced expiratory vital capacity, Evaluation of auscultatory pattern, Average change from baseline to end of study in Symptom score of Cough, Difficulty in expectorating, Dyspnea, Cyanosis, Expectoration characteristic, Evaluation clinical global impression on severity (CGI-S) and clinical global impression on improvement (CGI-I). The anticipated date of enrollment will be 05th Jun 2010, subject to registration at CTRI. This is not a global trial. |