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
|
|
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
|
|
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
|
|
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
|
|
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 |