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CTRI Number  CTRI/2021/12/038546 [Registered on: 09/12/2021] Trial Registered Prospectively
Last Modified On: 30/11/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A registry of data on lung oscillometry techniques (technique used to determine any obstruction or restriction in the lungs) of healthy participants, asthamatics, patients with COPD or any other respiratory disorders. 
Scientific Title of Study   Lung Oscillometry Registry for patients with various Respiratory Disorders and healthy subjects 
Trial Acronym  LEAD Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sundeep Salvi 
Designation  Director 
Affiliation  Chest Research and Training Pvt Ltd 
Address  First floor, Faith Centre, Sakore Nagar VIP Airport Road Vimanagar. Pune. Division: ARISE Network Room No: NA
Same as address 1
Pune
MAHARASHTRA
411014
India 
Phone  09921211000  
Fax    
Email  sundeepsalvi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deesha Ghorpade 
Designation  Research Scientist 
Affiliation  Chest Research and Training Pvt Ltd 
Address  First floor, Faith Centre, Sakore Nagar VIP Airport Road Vimanagar. Pune Division: ARISE Network Room No: NA
Same as address 1
Pune
MAHARASHTRA
411014
India 
Phone  09604643295  
Fax    
Email  deesha@crestindia.co.in  
 
Details of Contact Person
Public Query
 
Name  Deesha Ghorpade 
Designation  Research Scientist 
Affiliation  Chest Research and Training Pvt Ltd 
Address  First floor, Faith Centre, Sakore Nagar VIP Airport Road Vimanagar. Pune Division: ARISE Network Room No: NA
Same as address 1
Pune
MAHARASHTRA
411014
India 
Phone  09604643295  
Fax    
Email  deesha@crestindia.co.in  
 
Source of Monetary or Material Support  
Chest Research and Training Pvt ltd. First floor, Faith Centre, Sakore Nagar VIP Airport Road Vimanagar. Pune. Division: ARISE Network Room No: NA 
 
Primary Sponsor  
Name  Self Supported 
Address  First Floor, Faith centre, sakore Nagar. Off VIP airport road. Vimannagar. Pune -411014 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nagesh Dhadge  CGHS. Wellness Centre No. -5 . Pune, Maharashtra  CGHS. Wellness Centre No. -5 . Division: Pulmonary Medicine. Room No: NA. Pune, Maharashtra
Pune
MAHARASHTRA 
9822327445

ndhadge@hotmail.com 
Dr Sundeep Salvi  Chest Research and Training Pvt Ltd  1st Floor FAITH Centre, Division: ARISE Network Room No: NA, Survey No. 232, Sakore Nagar, Viman Nagar, Pune-411014, Maharashtra, India.
Pune
MAHARASHTRA 
9921211000

ssalvi@crestindia.co.in 
Dr Indu Khosla  Dr Indus New Born and Childcare centre  Dr Indus New Born and Childcare centre, Division: Pediatric division, Room No: NA A103 Aditi Apts, Opposite Versova Telephone Exchange 4 bunglows Andheri west Mumbai 400053
Mumbai (Suburban)
MAHARASHTRA 
9820144593

drinduk10@gmail.com 
Dr Sonia Dalal  Kalyan Hospital Vadodara, Gujarat  Division: Pulmonary Medicine. Room No: NA.101 - 102,Shree Hari Corner,R.C Dutt Road., behind Express Hotel, Vadodara, Gujarat 390015
Vadodara
GUJARAT 
9898089310

drsoniadalal@hotmail.com 
Dr Sainath Powar  Om Sai Childrens hospital  Division: Pediatric Pulmonary Room No:643/1-4 B, E Ward, Rukade Chembers, First Floor, Near Hariprasad Mangal Karyalaya, Shahpuri 2nd Lane, Kolhapur
Kolhapur
MAHARASHTRA 
9890168895

drsainathp@gmail.com 
Dr Sagar Warankar  Sanjivanee clinic  "Sanjivanee clinic" Shop No. Division: Pediatric Pulmonary Room No: 1/2, Vrundavan B CHS., Khanda Colony New Panvel.
Raigarh
MAHARASHTRA 
9920950850

drsagi2000@gmail.com 
Dr Suhas Bardapurkar  Shree Nursing Home  Shree Nursing Home. Division: Respiratory Department Room No:15, Sanmitra Colony, Aurangabad-431001 (M.S.)
Aurangabad
MAHARASHTRA 
9423150213

drsuhasbardapurkar@gmail.com 
Dr Harshavardhan Vhora  Vhora Chest Clinic  Division: Pulmonary Medicine Room No: NA. Cinema Road, Baramati. District Pune.
Pune
MAHARASHTRA 
9822329041

harshavardhan_vhora@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Royal Pune Independant Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
Patients  (1) ICD-10 Condition: J459||Other and unspecified asthma, (2) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (3) ICD-10 Condition: J479||Bronchiectasis, uncomplicated, (4) ICD-10 Condition: J439||Emphysema, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a)Healthy male and female subjects above the age of 5 years and adults
b) Children > 5 years and adults of all ages having respiratory diseases including asthma,
COPD, Interstitial lung disease, bronchiectasis.
 
 
ExclusionCriteria 
Details  Willingness to participate 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Predicted values/cut-offs/ Reference values for the Antlia FOT device for the South-East
Asian adult populations for Asthma, COPD, other ILD patients and healthy participants will
be derived
2. Predicted values/cut-offs/ Reference values for the IOS for the adult Indian population in
patients with Asthma, COPD, other ILD patients and healthy participants will be derived 
End of study 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
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)   20/12/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Study Synopsis
A) Title: Lung Oscillometry Registry for patients with various Respiratory Disorders and healthy subjects (LEAD Study) 
B) Background: To diagnose Obstructive Airways Disease (OADs), it is crucial to perform lung function tests. Not only do the lung function tests support to diagnose OADs, but also help to identify the severity of the obstruction and decide the pharmacotherapy based on the severity. The response to the administered intervention can also be monitored. Chest Physicians and other health care professionals have been using the conventional spirometer to diagnose Obstructive Airways Diseases (OADs) since many decades. But spirometry is not an easy test to be performed as it requires patient co-operation. In addition, spirometry cannot be performed in children below 5 years of age as well as the elderly people who have cognitive and physical impairment. Oscillometry techniques have proved to be an alternative sensitive diagnostic test to spirometry. Oscillometry technique is a non-invasive technique use to diagnose obstruction in the airways, which requires minimal patient co-operation. Unfortunately, unlike spirometry, there are no reference values or cut-offs available for the Indian population i.e., healthy and for patients with different respiratory diseases of different age group. Therefore, through the ARISE network, the LEAD study will form a lung oscillometry registry, whose data will be used to derive reference equations or cut-offs for the Indian as well as other countries healthy and with respiratory diseases, adult and paediatric population. Which in turn will contribute to the accuracy in diagnosing respiratory diseases by the physicians. 
C) Research Question: What are the lung oscillometry values/ Predicted values/cut-offs/ Reference value for healthy adults and children as well as in patients with asthma, COPD, interstitial lung diseases and other respiratory diseases. 
D) Aim of the Study: To develop a lung Oscillometry registry for Healthy adults and children to derive reference values as well as patients suffering with various respiratory disorders, such as asthma, COPD, interstitial lung diseases and other lung diseases so that cut-off values for various lung oscillometry indices can be generated. 
E) Study Design: Cross-sectional, observational clinic or hospital- based prospective study. Study Code: ARISE/LEAD/01/2021 INTERNATIONAL NETWORK FOR LUNG OSCILLOMETRY RESEARCH Page 3 of 16 Registry for Lung Oscillometry Research Version 01 22 October 2021
F) Study Population: The registry will include oscillometry data from healthy subjects and patients with asthma, COPD, ILD and other respiratory disorders across different states in India as well as outside India. 
G) Data Collection variables (Adults): (See Section 5.0 for detailed variables) 1. Demographics 2. Risk Factors: Educational Qualifications, Smoking Status, Type of residence, Type of cooking fuel, Occupation, Mosquito repellents and Medical History 3. Symptoms: Cough, Shortness of breath, Wheeze and Chest Tightness 4. COVID- 19 related questions 5. To be filled by Doctor: Final diagnosis 6. Spirometry Values 7. Lung Oscillometry Values 8. Other diagnostic reports to be uploaded if available 
H) Data Management: All the data will be entered at the study sites in an electronic format, through an app developed exclusively to enter data related to the LEAD study. At the back end, data will be downloaded in an excel format at the ARISE data coordination centre without the identification of the study participant. All the data will be cleaned and checked for completeness by the data management team at ARISE. Once complete data is received it will be locked and taken for analysis. 
I) Statistical Analysis plan: The preliminary analysis will be based on the descriptive statistics which includes frequency and percentages for categorical variables and mean and SD for continuous variable.
J) Outcomes expected: • Predicted values/cut-offs/ Reference values for the Antlia FOT device for the South-East Asian adult and paediatric populations in patients with Asthma, COPD, ILD and other respiratory diseases and healthy participants will be derived • Predicted values/cut-offs/ Reference values for the IOS for the adult and paediatric population in patients with Asthma, COPD, other ILD and other respiratory diseases and healthy participants will be derived 
 
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