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CTRI Number  CTRI/2022/12/047961 [Registered on: 08/12/2022] Trial Registered Prospectively
Last Modified On: 08/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   to study the signs ,symptoms and causes, types of ashtma, copd,aco and differentiation ,assesment of progress and outcome of the diseases 
Scientific Title of Study   Clinical, Physiological and Radiological features of poorly reversible obstructive airway diseases - a cross sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajesh Agarwal 
Designation  Proffesor and HOD of Respiratory medicine 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Rohilkhand Medical College and Hospital, room no 3113. 4,Pilibhit Bypass Rd,Pawan Vihar,Barielly,UttarPradesh 243006 Bareilly, Uttarpradesh.

Bareilly
UTTAR PRADESH
243006
India 
Phone  9837153548  
Fax    
Email  rajeshchest@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Agarwal 
Designation  Proffesor and HOD of Respiratory medicine 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Rohilkhand Medical College and Hospital, room no 3113. 4,Pilibhit Bypass Rd,Pawan Vihar,Barielly,UttarPradesh 243006 Bareilly, Uttarpradesh.

Bareilly
UTTAR PRADESH
243006
India 
Phone  9837153548  
Fax    
Email  rajeshchest@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SIVANI CHENNUPATI 
Designation  PG STUDENT, TB&CHEST 
Affiliation  Rohilkhand Medical College and Hospital 
Address  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY, PHILIBHITH BY PASS RAOD, BAREILLY-243006
Dr Rajesh Agarwal Proffesor and HOD of Respiratory medicine, Rohilkhand Medical College and Hospital, room no 3113. 4,Pilibhit Bypass Rd,Pawan Vihar,Barielly,UttarPradesh 243006 M - 9837153548
Bareilly
UTTAR PRADESH
243006
India 
Phone  7995944310  
Fax    
Email  spschennupati@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand medical college and hospital  
 
Primary Sponsor  
Name  Rohilkhand Medical College & Hospital 
Address  4, Pilibhit Bypass Rd , Pawan Vihar,UttarPradesh 243006 
Type of Sponsor  Private medical college 
 
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 Rajesh Agrawal  Rohilkhand Medical College & Hospital  Department of respiratory medicine, 1090/6, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006
Bareilly
UTTAR PRADESH 
9837153548

rajeshchest@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,RMCH  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients willing to give informed consent.
2. Patients diagnosed as obstructive airway disease with post bronchodilator FEV1/FVC <0.7 and post bronchodilator reversibility of FEV1 <12% or <400ml.
 
 
ExclusionCriteria 
Details  1. Patients with Lung parenchymal diseases
2. Patients with comorbidities like cardiac illness, diabetes or any other chronic disease.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To clinically differentiate between Asthma, COPD overlap
2. To compare features in HRCT thorax in COPD, Asthma, and ACO
3. To compare spirometry and DLCO in COPD, Asthma and ACO
 
4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Study the demographic profile of patients  4 weeks  
 
Target Sample Size   Total Sample Size="73"
Sample Size from India="73" 
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)   12/12/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 

Poorly reversible obstructive airway disease means Post Bronchodilator FEV1/FVC< 0.7 and Post bronchodilator reversibility of FEV1 <12% OR 400ML. Patients with poorly reversible obstructive airway disease can be ashtmatic or Reversible Chronic obstructive pulmonary disease(COPD). In Asthmatic patient may be poorly reversible due to improper treatment, due to exposure to Noxious particles, Smoking , Biomass Exposure. Reversible COPD may be COPD in non smokers, may be due to significant eosinophilia (>3%) or concomitant for asthma. They all exhibit more or less similar clinical presentation. There are different phenotypes which include poorly controlled Asthma, Asthma with exposure to Smoking and biomass fuel. The Phenotypes in COPD includes COPD in Nonsmokers,COPD with eosinophilia, COPD  concomitant with Bronchial Asthma. Obstructive airway disease (OAD) includes mainly Asthma, Chronic obstructive airway disease(COPD) or Asthma chronic obstructive pulmonary disease overlap (ACO)

Asthma is defined as a “heterogeneous disease characterized by chronic airway inflammation with history of respiratory symptoms like wheeze, shortness of breath, chest tightness and cough that vary for a period in severity, along with changing expiratory airflow limitation1.

Chronic obstructive pulmonary disease is a common, preventable and treatable disease. It is characterized by persistent respiratory symptoms and airflow limitation which is caused due to airway and / or alveolar abnormalities caused by significant exposure to harmful particles or gases.

When patients possess characteristic features of both asthma and COPD, they are often thought to have asthma-Chronic obstructive pulmonary disease overlap (ACO)2.

—  Airway diseases are caused mostly by inflammation and its nature differs in asthma and also in chronic obstructive airway disease (COPD). It is eosinophilic and CD4-driven in asthma, where as in chronic obstructive pulmonary disease (COPD) neutrophilic and CD8-driven inflammation.

—  Patients with Asthma chronic obstructive pulmonary disease overlap(ACO) have an asthmatic factor and therefore may exhibit the same characteristics to some extent as patients with asthma. Therefore, studying the clinical and pathological differences between Asthma chronic obstructive pulmonary disease overlap(ACO )and Chronic obstructive pulmonary disease (COPD )patients is essential.

—  This study is conducted to study the differences in the respiratory physiology of patients with chronic obstructive pulmonary disease (COPD), asthma-COPD overlap  (ACO), and asthma with airflow limitation (asthma FL+).

 
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