| CTRI Number |
CTRI/2009/091/000562 [Registered on: 17/02/2010] |
| Last Modified On: |
16/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Study to investigate real life effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma patients across Asia. |
Scientific Title of Study
Modification(s)
|
Real life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients across Asia: SMARTASIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D5890L00035 |
Protocol Number |
| NCT00939341 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Parthiv Mehta |
| Designation |
Medical Director |
| Affiliation |
|
| Address |
Sidhhachal Complex, Near TV Tower
Drive in Road
Ahmadabad
GUJARAT
380054
India |
| Phone |
91-9825031615 |
| Fax |
91-79-2685-7040 |
| Email |
parthivmehta@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ramesh Jagannathan |
| Designation |
Director - Clinical Research |
| Affiliation |
|
| Address |
AstraZeneca Pharma India Ltd
Avishkar P B No. 2483, Off Bellary Road, Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
91-80-6774-8515 |
| Fax |
91-80-2362-2052 |
| Email |
Ramesh.Jagannathan@astrazeneca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ramesh Jagannathan |
| Designation |
Director - Clinical Research |
| Affiliation |
|
| Address |
AstraZeneca Pharma India Ltd
Avishkar P B No. 2483, Off Bellary Road, Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
91-80-6774-8515 |
| Fax |
91-80-2362-2052 |
| Email |
Ramesh.Jagannathan@astrazeneca.com |
|
Source of Monetary or Material Support
Modification(s)
|
| AstraZeneca Pharma India Ltd., "Avishkar", P.B. No 2483, off Bellary Road, Hebbal; Bangalore - 560024 |
|
Primary Sponsor
Modification(s)
|
| Name |
AstraZeneca Singapore Pte Ltd |
| Address |
8 Wilkie Road #07-01 Wilkie Edge Singapore 228095
Regional Office - 7 Temasek Boulevard #28-01, Suntec Tower One, Singapore
038987 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| AstraZeneca Pharma India Ltd |
Block N1, 12th Floor, Manyata Embassy
Business Park, Rachenahalli, Outer Ring Road,
Bangalore – 560045, India |
| NIL |
|
|
Countries of Recruitment
Modification(s)
|
India
Thailand
Indonesia
China |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. S. Dinesh |
Bangalore Clinisearch |
No 416,4th cross, 2nd Block,Kalyan Nagar-560043
Bangalore
KARNATAKA |
+91 80 25450070
bhaktha.dinesh@gmail.com |
| Nagendra Prasad K.V |
Bengaluru Allergy & Immunology Research Foundation |
#1/2, 1st Cross, CSI Compound,Mission Road-560027
|
9844006879
ballergy@yahoo.co.uk |
| Dr. S. Nagarajan |
Coimbatore Chest Clinic |
M. S. S. Memorial Building, Opp. Savitha Hall,D. B. Road, R. S. Puram-641 002
Coimbatore
TAMIL NADU |
+91 9443055740
nagrajsri@gmail.com |
| Dr. Rajendra Mehta |
Dr. Mehta's Allergy and Asthma Care and Research Centre |
107, Asawa Chambers,Sapna-Sangeeta Road-452001
Indore
MADHYA PRADESH |
+91 731 2468737
drrajendramehta@hotmail.com |
| Mrinal Sircar |
Fortis Hospital |
B-22, Sector 62,Noida-201301
|
9871292226
mrinalsircar@yahoo.co.uk |
| Vijil Rahulan |
Global Hospitals and Health City |
439, Cheran Nagar,Perumbakkam-600100
Chennai
TAMIL NADU |
9884378289
vkrahulan@yahoo.com |
| Dr. Pradhyut Waghray |
Kunal Institute of Medical Specialities Pvt. Ltd. |
#5-9-41/1/A, New MLA Quarters Lane,Basheerbagh-500 029
Hyderabad
ANDHRA PRADESH |
9246531036
kimschest@rediffmail.com |
| Parthiv Mehta |
Mehta's Hospital |
Sidhhachal Complex, Near TV Tower,Drive in Road, Thaltej-380054
Ahmadabad
GUJARAT |
9825031615
parthivmehta@hotmail.com |
| Jayachandra |
Ramamurthy Hospital |
A K J Chest Clinic,3-6-147,Himayath Nagar-500029
Hyderabad
ANDHRA PRADESH |
9848013254
jayachandraa@hotmail.com |
| Vijayalakshmi T |
Sri Ramachandra Medical Center |
Sri Ramachandra University Campus,Porur-600116
Chennai
TAMIL NADU |
9840112099
drvthanasekaraan@yahoo.com |
| H S Dhumra |
Sterling Hospital Road |
Memnagar,-380 052
Ahmadabad
GUJARAT |
9825023160
drdumra@yahoo.co.in |
| BP Singh |
Surya Chest Foundation |
16/1326,Indira Nagar-226016
|
9415011669
bps2159@yahoo.com; |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Apex Independent Ethics Committee |
Approved |
| Bangalore Central Ethics Committee |
Approved |
| Cerebral Independent Review Board-Hyderabad For Human Research |
Approved |
| Ethics Committee, Bengaluru Allergy Centre |
Approved |
| Fortis Hospital Institutional Review Board |
Approved |
| Independent Ethics committee of Lucknow |
Approved |
| Institutional Ethics Committee Coimbatore Chest Clinic |
Approved |
| Institutional Ethics Committee(IEC), Global Hospitals and Health City |
Approved |
| Institutional Ethics Committee, Sri Ramachandra Medical Center |
Approved |
| Safe Search Independent Ethics Committee |
Approved |
| Sameeksha Independent Ethics Committee |
Approved |
| Sterling hospital Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Asthma, (1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Symbicort Turbuhaler |
Turbuhaler 160/4.5 µg delivered dose |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Provision of signed informed consent.
- Asthma diagnosis at least 6 months before visit 1 of study
- Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study |
|
| ExclusionCriteria |
| Details |
- Known or suspected allergy to active ingredients of study medication or excipients
- Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study
- Smoking, current or previous with a smoking history of ≥10 pack years |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional level |
At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in ACQ (5) score from baseline at country level |
At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks |
| Change in Asthma Quality of Life Questionnaire, standardized version (AQLQ (S)) domain and overall scores from baseline |
At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks |
| Study medication use (maintenance and reliever) in Diary Cards |
At initiate study treatment visit with 2 further visits at 4 and 8 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1150"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "867"
Final Enrollment numbers achieved (India)="162" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
18/12/2009 |
| Date of Study Completion (India) |
14/07/2010 |
| Date of First Enrollment (Global) |
10/07/2009 |
| Date of Study Completion (Global) |
19/08/2010 |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The propose of this study is to compare whether Symbicort Maintence & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation. Of 1150 patients planned regionally for the study, India enrolled 176 patients in the study. |