To understand the prevalence of Respiratory diseases in Asia.

Not Applicable

Recruiting

Conditions: adult patients receiving care for either asthma, allergic rhinitis (AR), chronic obstructive pulmonary disease (COPD), or rhinosinusitis

Registration Number: CTRI/2013/02/003386

Lead Sponsor: MSD Pharmaceuticals Pvt Ltd

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 Â± 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 5250

Inclusion Criteria

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.
Each subject must be capable of reading and/or comprehending one of the languages of the Informed Consent Form (ICF) and patient survey documents.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (4): Dr Paras Gangwals Clinic
🇮🇳
Delhi, DELHI, India
National Allergy Asthma Bronchitis Institute
🇮🇳
Kolkata, WEST BENGAL, India
St Johns Medical College and Hospital
🇮🇳
Bangalore, KARNATAKA, India
T N Medical College and BYL Nair Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Dr Paras Gangwals Clinic
🇮🇳Delhi, DELHI, India
Dr Paras Gangwal
Principal investigator
9811305970
drparasgangwal@gmail.com