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CTRI Number  CTRI/2013/02/003386 [Registered on: 13/02/2013] Trial Registered Retrospectively
Last Modified On: 11/02/2013
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To understand the prevalence of Respiratory diseases in Asia. 
Scientific Title of Study   A cross-sectional, multi-country, observational study of adult patients with respiratory diseases in the Asia Pacific region. 
Trial Acronym  APBORD 
Secondary IDs if Any  
Secondary ID  Identifier 
96373 Final, dated 01/Aug/2012  Protocol Number 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aloke Gopal Ghosal 
Designation  Director 
Affiliation  National Allergy Asthma Bronchitis Institute 
Address  National Allergy Asthma Bronchitis Institute, 11/3 Biresh Guha Street, Kolkata 700017

Kolkata
WEST BENGAL
700017
India 
Phone  03322902305  
Fax    
Email  agghosal@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aloke Gopal Ghosal 
Designation  Director 
Affiliation  National Allergy Asthma Bronchitis Institute 
Address  National Allergy Asthma Bronchitis Institute, 11/3 Biresh Guha Street, Kolkata 700017


WEST BENGAL
700017
India 
Phone  03322902305  
Fax    
Email  agghosal@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Susmita Kundu 
Designation  Co-investigator 
Affiliation  National Allergy Asthma Bronchitis Institute 
Address  National Allergy Asthma Bronchitis Institute, 11/3 Biresh Guha Street, Kolkata 700017

Kolkata
WEST BENGAL
700017
India 
Phone  09433238525  
Fax    
Email  ksusmita15@rediffmail.com  
 
Source of Monetary or Material Support  
MSD Pharmaceuticals Pvt Ltd 
 
Primary Sponsor  
Name  MSD Pharmaceuticals Pvt Ltd 
Address  8th Floor, Platina Building, C-59, G-Block, Bandra Kurla Complex, Bandra-E, Mumbai 400098 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Malaysia
Republic of Korea
Singapore
Taiwan
Thailand  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Paras Gangwal  Dr Paras Gangwals Clinic  17 RPS, DDA Flats, Mansarovar Park, New Delhi, 110032
New Delhi
DELHI 		 9811305970

drparasgangwal@gmail.com 
Dr Aloke G Ghosal  National Allergy Asthma Bronchitis Institute  11/3 Dr Biresh Guha Street, Kolkata 700017
Kolkata
WEST BENGAL 		 9830068023

agghosal@yahoo.com 
Dr G D Ravindran  St Johns Medical College and Hospital  Sarjapur Road, Bangalore, 560034
Bangalore
KARNATAKA 		 9880081770

gdravindran@gmail.com 
Dr Girish Rajadhyax  T N Medical College and BYL Nair Hospital  Ground Floor, G Building, Dr A L Nair RD, Mumbai 400008
Mumbai
MAHARASHTRA 		 9821695349

girishraj63@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Hippocrates Independant Ethics Committee. Plot no 26, K-1 Ext Mohan Garden, Uttam Ngr, New Delhi 110059  Approved 
Institutional Ethics Committee BYL Nair Hospital and TN Medical College, Mumbai Central, Mumbai 400008  Approved 
Institutional Ethics Committee NAABI, 11/3 dr Biresh Guha St, Kolkata 700017  Approved 
St Johns Medical College and Hospital Institutional Ethical Review Board, Grnd floor, St Johns Medical College, Sarjapur Rd, Bangalore 560034  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  adult patients receiving care for either asthma, allergic rhinitis (AR), chronic obstructive pulmonary disease (COPD), or rhinosinusitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  A subject must meet all the criteria listed below to be eligible.
1.Each subject (or subjects legal representative) must be willing and able to provide written informed consent for the study.
2.Each subject must be greater than equal to 18 years of age. A subject may be of either sex, and any race or ethnicity.
3.Each subject must have presented to the study site to receive care for a new or existing diagnosis of asthma, allergic rhinitis, COPD or rhinosinusitis.
4.
Each subject must be capable of reading and/or comprehending one of the languages of the Informed Consent Form (ICF) and patient survey documents. 
 
ExclusionCriteria 
Details  A subject meeting any of the exclusion criteria listed below must be excluded from participating in the study:

The subject has participated in any interventional clinical study within the 12 weeks prior to entering the current study.

The subject or a family member is among the personnel of the investigational or Sponsor staff directly involved with this study.

The subject was screened and consented (enrolled) to participate in this study at a previous visit to the physician or at any other study site. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the proportion of adult patients receiving care for either asthma, allergic rhinitis (AR), chronic obstructive pulmonary disease (COPD), or rhinosinusitis among patients receiving care for a respiratory disease, as diagnosed by the physician.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. To estimate the proportion of patients receiving care for asthma, AR, COPD, or rhinosinusitis who are newly diagnosed.
2. To estimate the proportion of patients receiving care for asthma, AR, COPD, or rhinosinusitis who have combinations of the four diseases.
3. (a) To estimate the proportion receiving care for asthma, AR, COPD, or rs who report cough as a symptom.
(b) To estimate the proportion receiving care for asthma, AR, COPD, or rs who report cough as the main reason. 		 1 year 
 
Target Sample Size   Total Sample Size="5250"
Sample Size from India="1000" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   17/11/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/11/2012 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
2.0
PROTOCOL SYNOPSIS
TITLE OF STUDY: A cross-sectional, multi-country, observational study of adult patients with respiratory diseases in the Asia Pacific region (Phase Other, Protocol No. 96373)
ABBREVIATED TITLE: The Asia Pacific Burden of Respiratory Diseases study (APBORD)
STUDY OBJECTIVES
Primary Objective: To estimate the proportion of adult patients receiving care for either asthma, allergic rhinitis (AR), chronic obstructive pulmonary disease (COPD), or rhinosinusitis among patients receiving care for a respiratory disease, as diagnosed by the physician.
Secondary Objectives:
1. To estimate the proportion of adult patients receiving care for asthma, AR, COPD, or rhinosinusitis who are newly diagnosed.
2. To estimate the proportion of adult patients receiving care for asthma, AR, COPD, or rhinosinusitis who have combinations of the four diseases.
3. (a) To estimate the proportion of adult patients receiving care for asthma, AR, COPD, or rhinosinusitis who report cough as a symptom.
(b) To estimate the proportion of adult patients receiving care for asthma, AR, COPD, or rhinosinusitis who report cough as the main reason for their medical visit.
Exploratory Objectives:
1. To describe the healthcare resource use (HCRU) and work loss associated with asthma, AR, COPD, and rhinosinusitis.
2. (a) To describe the general functional health and well being of patients with asthma, AR, COPD, and rhinosinusitis.
(b) To describe the disease-specific health-related quality of life (HRQoL) of patients with a primary diagnosis of asthma, COPD, or rhinosinusitis.
Study Design
Overview: This is a cross-sectional, multi-country, observational study of adult patients with respiratory diseases across 6 countries in the Asia Pacific region (India, Korea, Malaysia, Singapore, Taiwan, and Thailand).
Number of Study Centers: Approximately 22 sites in total.
Duration of Participation: Each subject will participate in the study from the time the subject signs the Informed Consent Form (ICF) through the final contact on the same day.
Duration of Study: The study duration will be approximately 1 year (from first subject signing informed consent through final contact with last subject).
Key Inclusion Criteria: Patients receiving care for a new or existing diagnosis of asthma, allergic rhinitis, COPD or rhinosinusitis are eligible to participate in the study.
STATISTICAL METHODS:
Data Set to be Analyzed: The primary analysis is to be performed on all enrolled (consented) subjects with a completed Physician Survey.
Sample Size: Applying the assumption that 4% of all patients receiving care for a respiratory disease would have a new or existing primary diagnosis of asthma, approximately 5,000 subjects (providing precision of ± 0.3% around the assumed 4%) will be enrolled. Asthma was selected to power the sample size calculation as available data suggest it is the least common of the four diseases. The underlying assumptions in the sample size calculation will be reassessed following enrollment of the first 1,000 patients.
Analysis: The primary outcome for the study is the distribution of patients receiving care for asthma, AR, COPD, and rhinosinusitis as a proportion of all patients receiving care for a respiratory disease. The primary outcome will be analyzed using descriptive statistics.
The key secondary outcomes include estimating the proportion of patients receiving care for asthma, AR, COPD, or rhinosinusitis who are newly diagnosed, have combinations of the four diseases, and report cough as a symptom and main reason for presentation. Additional exploratory outcomes include HCRU, work loss and HRQoL. All secondary and exploratory objectives will be analyzed using descriptive statistics.
All analyses will be stratified by country and by practice type (i.e. primary care versus specialist care).
Interim Analysis: No formal interim analyses are planned.
 
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