| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
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+). |