FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088829 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Checking for asthma and lung problems in people who don’t know they have it, by asking simple questions in homes of Ullal Taluk area, Dakshina Kannada. 
Scientific Title of Study   Primary Screening for Undiagnosed Asthma and Chronic Obstructive Pulmonary Disease (UCAP) using UCAP Risk Score Questionnaire and its associated risk factors in a Community of Ullal Taluk, Dakshina Kannada: A Cross-Sectional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
YEC-4/2025/042  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavya Shettigar 
Designation  Assistant Professor 
Affiliation  Yenepoya School of Allied Health Sciences 
Address  Yenepoya School of Allied Health Sciences, Yenepoya (Deemed to be University), Mudipu Campus, Near Soorya Tech Park, Kayargoli, Kurnad post, Bantwal Tq

Dakshina Kannada
KARNATAKA
574153
India 
Phone  9741734428  
Fax    
Email  kavyashettigar22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kavya Shettigar 
Designation  Assistant Professor 
Affiliation  Yenepoya School of Allied Health Sciences 
Address  Yenepoya School of Allied Health Sciences, Yenepoya (Deemed to be University), Mudipu Campus, Near Soorya Tech Park, Kayargoli, Kurnad post, Bantwal Tq


KARNATAKA
574153
India 
Phone  9741734428  
Fax    
Email  kavyashettigar22@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kavya Shettigar 
Designation  Assistant Professor 
Affiliation  Yenepoya School of Allied Health Sciences 
Address  Yenepoya School of Allied Health Sciences, Yenepoya (Deemed to be University), Mudipu Campus, Near Soorya Tech Park, Kayargoli, Kurnad post, Bantwal Tq


KARNATAKA
574153
India 
Phone  9741734428  
Fax    
Email  kavyashettigar22@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya School of Allied Health Sciences, Yenepoya (Deemed to be University), Mudipu Campus, Near Soorya Tech Park, Kayargoli, Kurnad post, Bantwal Tq - 574153, Karnataka, India. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kavya Shettigar  Belma Gram Panchayth Area  Belma Gram Panchayth area (All residences), Deralakatte, Ullal Taluk, Dakshina Kannada - 575018
Dakshina Kannada
KARNATAKA 		 9741734428

kavyashettigar22@gmail.com 
Kavya Shettigar  Munnuru Gram Panchayth Area  Munnuru Gram Panchayth Area (All Residences), Munnuru, Ullal Taluk, Dakshina Kannada - 575017
Dakshina Kannada
KARNATAKA 		 9741734428

kavyashettigar22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Gram Panchayth Office  No Objection Certificate 
Yenepoya Ethics Committee - 4  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Have experienced one or more of the following breathing problems within the past 6 months: Shortness of breath, Wheezing, Increased mucus or sputum, or Prolonged cough. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Have experienced one or more of the following breathing problems within the past 6 months:
1. Shortness of breath
2. Wheezing
3. Increased mucus or sputum, or
4. Prolonged cough. 
 
ExclusionCriteria 
Details  Participants reporting a previous physician diagnosis of asthma or COPD. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure is the proportion of individuals identified as at risk for undiagnosed asthma and COPD based on the UCAP risk score, which was used for sample size calculation and to assess the effect of the screening approach.  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome measures are determined using lifestyle habits, environmental exposures & demographic characteristics affect the likelihood of undiagnosed asthma & COPD.  At Baseline 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   N/A 
Date of First Enrollment (India)   23/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Several studies have utilised distinct screening questionnaires to identify COPD and Asthma independently. Nevertheless, not many studies use a single validated technique to evaluate the risk score for undiagnosed asthma and COPD in the general population simultaneously. The burden of respiratory diseases can be decreased by early identification of high-risk patients, resulting in better disease management and prompt medical intervention. This study aims to close this gap by using the UCAP questionnaire for thorough risk assessment. The result will help enhance early diagnosis and treatment methods at the community level, direct healthcare policy, and increase public awareness about respiratory conditions. 
Close