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CTRI Number  CTRI/2025/08/092412 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   How Chronic Obstructive Pulmonary Disease Affects Patients Life  
Scientific Title of Study   Assessment Of Factors Associated With Poor Quality Of Life Of Chronic Obstructive Pulmonary Disease Patients - A Cross-Sectional Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Albin Manoj 
Designation  PG Student 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer Derlakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  85473399405  
Fax    
Email  albinmanoj72@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Barma Naga Raju 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer Derlakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9949617946  
Fax    
Email  barmanagaraju08@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Barma Naga Raju 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer Derlakatte Mangalore


KARNATAKA
575018
India 
Phone  9949617946  
Fax    
Email  barmanagaraju08@gmail.com  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Paneer, Derlakatte, Mangalore, Karnataka, 575018 
Justice KS Hegde Charitable Hospital, Derlakatte, Mangalore, Karnataka, 575018 
 
Primary Sponsor  
Name  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Paneer, Derlakatte, Mangalore, Karnataka, 575018  
Type of Sponsor  Other [Academic Institute] 
 
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 
Dr Chandramouli M T  Justice KS Hegde Charitable Hospital  Department of Pulmonary Medicine
Dakshina Kannada
KARNATAKA 
9632551141

mouli.aims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of 18 years and above
Diagnosed with COPD with or without comorbidities
Patients willing to give consent

 
 
ExclusionCriteria 
Details  Patient with severe illness
Patient who can’t communicate properly
Psychiatric, cognitive, and terminal illness patients
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•This study will give the insights about domains which are affecting the QoL of the chronic obstructive pulmonary disease patients  8 months 
 
Secondary Outcome  
Outcome  TimePoints 
•The current study will highlight the factors affecting the poor QoL in Chronic obstructive pulmonary disease patients which helps the physicians in management of the COPD.  8 months 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   16/08/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

INTRODUCTION

COPD is a common avoidable, and treatable respiratory disease is characterized by persistent breathing difficulties and airflow limitation, due to abnormal inflammatory response of the airways to noxious particles or gases. According to data from India, the prevalence of COPD rises with age and reaches an exponential level beyond the age of thirty. The prognostic factors associated with health-related quality of life (HrQoL) are smoking, obesity, diseases such as depression, older age, comorbidity which may aggregate the condition of COPD.

OBJECTIVES OF STUDY

To assess the health-related quality of life among the chronic obstructive pulmonary disease patients. To assess the factors associated with poor health-related quality of life of chronic obstructive pulmonary disease patient.

JUSTIFICATION OF THE STUDY

There are various factors which affects the HrQoL of the COPD patients which causes economic burden to patients and healthcare system. Assessment of the HrQoL of the COPD patients is important because it helps in planning the treatment regimen and identify the progression of the disease. Identification these risk factors which are associated with poor HrQoL of the COPD patients helps in better planning the treatment and education the patients.

METHODOLOGY

It is an observational cross-sectional study will be conducted at the Department of Pulmonary Medicine, Justice K S Hedge Charitable Hospitable. Patients of aged 18 years and above with confirmed diagnosis of Chronic Obstructive Pulmonary disease and willing to participate in the study will be included. A structured data collection form will be used to collect the sociodemographic and clinical details of the patients. St. George’s Respiratory Questionnaire for COPD will be used assess the HrQoL of COPD patients.

STATISTICAL ANALYSIS

Qualitative data will be expressed in frequency and percentage Quantitative variable will be expressed as mean ±SD or median (Q1, Q3). Multiple linear regression will be used to find the factors associated to QoL of COPD patient. SPSS software version 2.0 will be used for statistical analysis. P value <0.05 will be consider statistically significant.

OUTCOME MEASURES

This study gives the insights about domains which are affecting the HrQoL of the chronic obstructive pulmonary disease patients. The current study highlights the factors affecting the HrQoL in Chronic obstructive pulmonary disease patients which helps the physicians in management of the COPD.

 
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