| CTRI Number |
CTRI/2013/03/003504 [Registered on: 21/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
20/03/2013 |
| 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 Seratrodast in patients with Asthma |
|
Scientific Title of Study
|
A Multi-centric, Double blind, Randomized, Comparative Clinical trial to Evaluate the Efficacy and Safety of Seratrodast in the treatment of Asthma |
| Trial Acronym |
SEMO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SER/ZUV/CT/03/11, version 01, Dated 16.03.11 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Indani |
| Designation |
Trial Coordinator |
| Affiliation |
Genelife Clinical Research |
| Address |
33 34 37 Cine Wonder mall
Kapurbawdi GB road
Thane
MAHARASHTRA
400607
India |
| Phone |
02265242666 |
| Fax |
02225841316 |
| Email |
ashishi@genelifecr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Indani |
| Designation |
Trial Coordinator |
| Affiliation |
Genelife Clinical Research |
| Address |
33 34 37 Cine Wonder mall
Kapurbawdi GB road
Thane
MAHARASHTRA
400607
India |
| Phone |
02265242666 |
| Fax |
02225841316 |
| Email |
ashishi@genelifecr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Indani |
| Designation |
Trial Coordinator |
| Affiliation |
Genelife Clinical Research |
| Address |
33 34 37 Cine Wonder mall
Kapurbawdi GB road
Thane
MAHARASHTRA
400607
India |
| Phone |
02265242666 |
| Fax |
02225841316 |
| Email |
ashishi@genelifecr.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Ltd |
| Address |
office no 5119 5th floor D wing Oberoi garden estates Chandivali Andheri east Mumbai 400072 Maharashtra India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Genelife Clinical Research |
33 34 37 Cine wonder mall Kapurbawdi GB road Thane West 400607 Maharashtra India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSantosh Kumar |
ChhatrapatiShahujiMaharaj MedicalUniversity |
ChhatrapatiShahujiMaharaj MedicalUniversity
Department of Pulmonary Medicine
Lucknow 226003 UP
Lucknow
UTTAR PRADESH |
8090686388
skumarchest@yahoo.com |
| Dr Mukarram Ali |
Faith Medical and Chest Centre |
Faith Medical and Chest Centre
Rein bazar road Yakuthpura
Hyderabad
ANDHRA PRADESH |
9885372365
drmdmukarramali@yahoo.com |
| Dr subramanian Natrajan |
Pooja nursing home PVT LTD |
Pooja nursing home PVT LTD
Shreeram Apartment JN Road
Mulund
Mumbai
MAHARASHTRA |
9870566767
cnsubu@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum, Mumbai, Dr. Md. Mukarram Ali |
Approved |
| Clinical Ethics Forum,Mumbai, Dr Subramanian Natarajan |
Approved |
| Institutional Ethics Committee, Lucknow, Dr. Santosh Kumar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bronchial Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Monteleukast 10 mg |
Monteleukast 10 mg once in a day orally for 28 days |
| Intervention |
Seratrodast 80 mg |
Seratrodast 80 mg once in a day orally is New proposed treatment for asthma for 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Non-smoking male or female patients between 18 and 65 years of age.
2 Patients with active bronchial asthma, of mild to moderate severity, as defined by the National Asthma Education and Prevention Program.
a FEV1 60% of predicted normal value.
b. Morning PEF 60% of predicted value.
c. FEV1 and PEF requirements of items a and b are achieved with the lowest dose of an inhaled steroid as monotherapy.
3. Patients should be expectorating sputum of 20 g/d for at least 2 weeks prior to study.
4. Patients willing to give written informed consent and willing to comply with trial protocol.
|
|
| ExclusionCriteria |
| Details |
1 Patients with a known history of hypersensitivity to study medications
2 Patients receiving a course of oral or inhaled high dose corticosteroids or any other anti inflammatory drugs such as sodium cromoglycate or nedocromil sodium during the previous 4 weeks
3 Patients receiving either a short acting or a long acting beta2 agonists either as monotherapy inhaler puffs or in combination with an corticosteroid as inhaler puffs
4 Patients receiving a course of antibiotics or mucolytic agents during the previous 4 weeks
5 Patients showing evidences of pulmonary infection on chest radiograph and sputum bacteriology bacteria more than 107 per mL
6 Females that are pregnant breast-feeding or not using birth control and are sexually active
7 Serious systemic disorders incompatible with the study either acute or chronic affecting any other target organ in the human body
8 Patients with history of poorly controlled associated disease such as: heart disease thyroid disorders coagulation disorders and hematologic problems etc.
9 Historyof cancer
10 Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients showing an improvement in the severity of asthma clinical symptoms |
Proportion of patients showing an improvement in the severity of asthma clinical symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in the various lung function parameters |
4 Week |
| Mean change from baseline in the sputum parameters quantity viscolasticity and eiosinophil cationic protein |
4 Week |
| Mean change from baseline in the muco ciliary clearance |
4 Week |
| Proportion of patients with adverse events associated to the drug |
4 Week |
|
|
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)
|
05/08/2011 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Planned to publish yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a prospective �A Multi-Centric, Double Blind, Randomized, Comparative Clinical Trail to Evaluate the Efficacy and Safety of Seratrodast in the treatment of Asthma�. In this study we have to generate data for 200 subjects across four sites in two months of recruitment period. We identified the sites on the basis of their medical specialty and relevant experience, type of Institute and its geographic location, paramedical staff, Investigator’s qualifications and their availability for the entire duration of the study, and most importantly their recruitment rate. These identified sites comprise of both private institutions as well as government institutions to recruit patients from all economical sets. |