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CTRI Number  CTRI/2012/12/003256 [Registered on: 24/12/2012] Trial Registered Retrospectively
Last Modified On: 16/07/2013
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Survey 
Study Design  Other 
Public Title of Study   Questionnaire Survey of Asthma patients in 4 Indian cities 
Scientific Title of Study   Asthma Control Survey 2012(Community based patient questionnaire survey to assess Asthma Control in 4 Indian cities) 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
OTH116516  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Priya Jain 
Designation  Research Manager 
Affiliation  Ipsos Health Care, India 
Address  Ipsos Research Private Limited. 7th Floor, 701, Boston House, Suren Road, Andheri (East), Mumbai.
Ipsos Research Private Limited. 7th Floor, 701, Boston House, Suren Road, Andheri (East), Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400 093
India 
Phone  09619798299  
Fax    
Email  priya.jain@ipsos.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sadhna Joglekar 
Designation  Executive Vice President 
Affiliation  Glaxosmith Kline Pharmaceuticals 
Address  Glaxo Smith Kline Pharmaceuticals, 252, GSK House, Dr Annie Besant Road,Worli, Mumbai

Mumbai
MAHARASHTRA
400025
India 
Phone  02224959405  
Fax    
Email  sadhna.j.joglekar@gsk.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sadhna Joglekar 
Designation  Executive Vice President 
Affiliation  Glaxosmith Kline Pharmaceuticals 
Address  Glaxo Smith Kline Pharmaceuticals, 252, GSK House, Dr Annie Besant Road,Worli, Mumbai

Mumbai
MAHARASHTRA
400025
India 
Phone  02224959405  
Fax    
Email  sadhna.j.joglekar@gsk.com  
 
Source of Monetary or Material Support  
GlaxoSmithKline Pharmaceuticals 
 
Primary Sponsor  
Name  Glaxo Smith Kline Pharmaceuticals 
Address  252, GSK House, Dr Annie Besant Road, Worli, Mumbai MAHARASHTRA 400030 India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priya Jain  Ipsos health care  7th Floor, 601 Boston House, Suren Road, Andheri (E), Mumbai 400093, India
Mumbai
MAHARASHTRA 
09619798299
0226195509
priya.jain@ipsos.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinical Ethics Forum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Asthma 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Physician diagnosed Asthma together with either current use of Asthma medication or the occurence of Asthm attacks and symptoms during the previous year. 
 
ExclusionCriteria 
Details  Individuals with smoking Index more than 100 will be excluded from this survey 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Proportion of all patients with ‘not well controlled’ asthma (ACT score less than or equal to 19).
2. Proportion of all patients with ‘controlled’ asthma (ACT score more than 19).
 
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Current level of asthma control based upon ACT score (stratified by age), usage of diagnostic and monitoring tools for asthma, usage of different classes of asthma medication, level of healthcare utilization, level of work productivity and activity impairment (WPAI), relation between ACT score and WPAI outcomes, between ACT score and different classes of asthma medication, between ACT score and adherence to asthma medication.  3 months 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="550" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/07/2012 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Brief Summary  

The Global Initiative for Asthma (GINA) guidelines advocates the management of asthma based upon the level of control rather than disease severity. The main goal of asthma treatment is to achieve and maintain clinical control. The Asthma Control Test (ACT) is a simple and validated  tool to measure asthma control. Amongst the Indian patients (from Mumbai, Delhi, Kolkata, Bengaluru) in Asthma Insights and Reality in Asia-Pacific (AIRIAP) 2006 survey, 70% adults and 48% children had ‘not well-controlled asthma’ as indicated by an ACT score of 5-19. Over the last 6 years it appears that access to diagnostic tests,  monitoring tools and better treatment options for asthma has increased in India. Therefore we expect that asthma control has improved in the last 6 years.

This is a community based cross-sectional questionnaire survey of 550 asthma patients (ages 4 to 50 years) across 4 Indian cities, viz Mumbai, Delhi, Bengaluru and Kolkata. The aim of this survey will be to assess the current level of asthma control based upon the ACT score, the usage of diagnostic and monitoring tools for asthma, the usage of different classes of asthma medication (during 4 weeks preceeding this survey), the level of healthcare utilization (during 12 months preceding this survey), the level of work productivity and activity impairment (WPAI, during 7 days preceding this survey), the relation between ACT score and WPAI outcomes, between ACT score and different classes of asthma medication, between ACT score and adherence to asthma medication. This survey will be conducted by Ipsos Healthcare using cluster sampling  methodology applied to 28 sampling points each in Mumbai (n=140) and Delhi (n=140) and 27 sampling points each in Bengaluru (n=135) and Kolkata (n=135). The results of this survey will help us to understand the extent to which these Indian cities have met GINA defined goals for asthma control (well controlled, total control). If the data indicate that these cities have not reached this level of control, the results will help us to identify and focus on those areas that need additional resource to achieve guideline defined asthma control. The results will also help us to understand whether the level of asthma control, the usage of diagnostic and monitoring tools for asthma, the usage of different classes of asthma medication and the level of healthcare utilisation has changed over the last 6 years, between 2006 and 2012.

 
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