CTRI/2024/05/067343 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On:
07/08/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Screening
Study Design
Other
Public Title of Study
Study to create a library of signals generated by asthmatic and non-asthmatic subjects through a smartphone-based App to estimate lung health
Scientific Title of Study
A prospective, interventional study to develop a library of signals generated on forceful oral exhalation by asthmatic and non-asthmatic subjects through a smartphone-based App
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CP/05/23, Version 01, dated 22/02/2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jaideep Gogtay
Designation
Executive Vice President, Global Chief Medical Officer.
Affiliation
Cipla Limited
Address
Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India
Mumbai MAHARASHTRA 400008 India
Phone
02223025145
Fax
Email
jgogtay@cipla.com
Details of Contact Person Scientific Query
Name
Dr Sandesh Sawant
Designation
Vice President, Head- Clinical Trials
Affiliation
Cipla Limited
Address
Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India
Mumbai MAHARASHTRA 400008 India
Phone
02223025006
Fax
Email
sandesh.sawant3@cipla.com
Details of Contact Person Public Query
Name
Mr Abhijit Vaidya
Designation
Associate Director, Clinical Trials
Affiliation
Cipla Limited
Address
Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India
Room No 65/1B, Department and
Division Pulmonary
medicine, Karve Rd, above
Bank Of India, Nal Stop, Apex Colony, Erandwane, Pune, Maharashtra -411004
Pune MAHARASHTRA
9822322941
rajeev27adkar@gmail.com
Dr Vipul Khandelwal
Apex Hospitals Pvt Ltd
Department and
Division Medicine,
Room No P4 & 6, Malviya Industrial
Area, Malviya Nagar
Jaipur, Rajasthan
302017 Jaipur RAJASTHAN
9415007110
smsdgupta@gmail.com
Dr Deepti Rathee
Arora Allergy Asthma and Chest Care Centre
Department and
Division Respiratory
medicine, Room No 26,
Arora Allergy Asthma
and Chest Care Centre,
26, LIC Colony,
Anasagar Circular
Road, Ajmer-305001, Ajmer RAJASTHAN
9711175244
piyusharora23@gmail.com
Dr S Balamurugan
Chest & Diabetis Research Institute
Room No.: 2, Department and
Division Respiratory
Medicine, First Cross Street, Janaki Nagar Extension,Valasaravakkam, Chennai, Tamil Nadu - 600087 Chennai TAMIL NADU
Sai Mangal Apartment, near Metro Chemist, Kandivali, Sector 8, Kandivali West, Mumbai, Maharashtra 400067 Mumbai (Suburban) MAHARASHTRA
7021825018
sendtorajas@gmail.com
Dr Komalkirti Apte
Excellentia Consulting Services
Room No.: 1706, Department: Pulmonary, Division: Pulmonary Medicine, Tower 6, F Residences, Wadgaonsheri, Pune
411014
Pune MAHARASHTRA
9623023295
kapte@excellentiacs.co.in
Dr Prabhat Kumar Sharma
Maharaja Agrasen Superspeciality Hospital
Department and
Division Medicine,
Ground floor, Sector-07, Central Spine, Vidyadhar Nagar, Rajasthan
302039 Jaipur Jaipur RAJASTHAN
9983995050
pksharma.clinical@gmail.com
Dr Pawan Kumar
Pt. B. D. Sharma, PGIMS, Rohtak
Room No.: 17, Department: Pulmonary & Critical Care, Division: Pulmonary & Critical Care Medicine, Near old emergency ward, Rohtak-124001, Haryana Rohtak HARYANA
8437013094
ga.ps.complete@gmail.com
Dr Namdev Jagtap
Ranka Hospital
Room No.: 157 / 5, Department and division of General Medicine, SS Dhage Rd, near Swargate, Mukund Nagar, Pune, Maharashtra 411037 Pune MAHARASHTRA
9823914414
drjagtapdev@gmail.com
Dr Shyam Narain Gupta
Sanjivini hospital & Research Center
Department and Division of Respiratory Medicine, Room No: CP-23 Viraj Khand, Near Hahnemann
Chauraha ,Gomti Nagar ,Lucknow -226010 Uttar Pradesh, India"
Lucknow UTTAR PRADESH
9415007110
smsdgupta@gmail.com
Dr Himanshu Pophale
Shreeyash Hospital
Department and Division of Pulmonary Medicine, 2nd Floor, At Roopam Corner, Near Garware Bridge, Opposite Chitale Bandhu Mithaiwale, Deccan Gymkhana, Pune 411004 Pune MAHARASHTRA
7588693308
himanshupophale@yahoo.co.in
Dr Manish Jain
Shri Navkar Hospital
Department and
Division TB &
Respiratory diseases,
Room No G-11, Ground Floor, Shubham Apartment, Central Spine, Vidyadhar
Nagar, Jaipur-302039 Jaipur RAJASTHAN
9414414834
doctormanishjain2@gmail.com
Dr Mukesh Goyal
Shwass Clinic
Department and Division of Respiratory Medicine, Room No. N31, Behind RHB Office, Sagar Vihar Colony, Vaishali Nagar, Ajmer-305001 Ajmer RAJASTHAN
7339966724
mukeshgoyaldr@gmail.com
Dr Bhavesh Vaghani
SwaaS Chest Allergy & Sleep Clinic
Room No. 304, 3rd floor, Pulse House, Near Venus Hospital, Lal Darwaja – Katargam Road, Surat, Gujarat 395003 Surat GUJARAT
9904262829
dr.bjvaghani@gmail.com
Dr Kalpesh Panchal
Swastik Lungs Care & Allergy Clinic
Department and Division of Respiratory Medicine, Room No.: A/301, Shlok Infinity, Opposite Vishwakarma Temple, Near Gota Railway Overbridge, Chandlodiya, Ahmedabad- 382481 Ahmadabad GUJARAT
Institutional Ethics Committee Pt. B. D. Sharma, PGIMS, Rohtak (Dr Pawan Kumar Singh)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr Bhavesh Vaghani)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr Arti Shah)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr Himanshu Pophale)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr Komalkirti Apte)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr Rajas Walinjkar)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr Rajiv Adkar)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr S.N.Gupta)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr. Deepti Rathee)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr. Kalpesh Panchal)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr. Manish Jain)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr. Mukesh Goyal)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr. Namdev Jagtap)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr. Prabhat Kumar Sharma)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr. Vipul Khandelwal)
Approved
Royal Pune Independent Ethics Committee, Pune (Dr.S. Balamurugan)
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Non-asthmatic Volunteers
Patients
(1) ICD-10 Condition: J459||Other and unspecified asthma,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
NA
NA
Intervention
SMARTPHONE-BASED HEALTHCARE APP (SOFTWARE AS MEDICAL DEVICE)
Development of a library of signals generated on forceful oral exhalation by asthmatic and non-asthmatic subjects
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
INCLUSION CRITERIA FOR ASTHMATIC SUBJECTS
1. Subjects providing consent for capturing and sharing their details.
2. Adults of any gender with age of 18 years and above.
3. Prior diagnosis of asthma or pulmonologist confirmed asthma.
INCLUSION CRITERIA FOR NON-ASTHMATIC SUBJECTS
1. Subjects providing consent for capturing and sharing their details
2. Adults of any gender with age of 18 years and above.
3. Non-Asthmatic subjects with following criteria (all criteria have to be met)
i. No respiratory symptoms viz breathlessness, cough, wheezing, chest tightness
ii. No previous diagnosis of any lung disorder
iii. No family history of asthma/allergy
iv. No use of medication for lung disorder
ExclusionCriteria
Details
EXCLUSION CRITERIA FOR ASTHMATIC SUBJECT
1. H/o hernia, abdominal surgery or cardio-pulmonary surgery
2. Any recent asthma exacerbation or hospitalization
3. Subjects who are cognitively challenged or have psychological disorders.
4. H/o COPD, bronchiectasis, interstitial lung disease, cystic fibrosis, pulmonary hypertension and tuberculosis.
5. H/o pneumothorax, ventilatory support, severe respiratory distress, structural upper airway disease.
6. H/o breathlessness due to heart disease, anaemia, pneumonia.
7. Any active respiratory infection
8. As per investigator’s discretion subject is not able to blow forcefully
EXCLUSION CRITERIA FOR NON-ASTHMATIC SUBJECTS
1. H/o hernia, abdominal surgery or cardio-pulmonary surgery
2. Any recent asthma exacerbation or hospitalization
3. Subjects who are cognitively challenged or have psychological disorders.
4. H/o COPD, bronchiectasis, interstitial lung disease, cystic fibrosis, pulmonary hypertension and tuberculosis.
5. H/o pneumothorax, ventilatory support, severe respiratory distress, structural upper airway disease.
6. H/o breathlessness due to heart disease, anaemia, pneumonia.
7. Any active respiratory infection
8. As per investigator’s discretion subject is not able to blow forcefully
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Library of signals generated on forceful oral exhalation to develop health related cut-off values for
Asthmatic and Healthy volunteers.
Single Day Visit.
Secondary Outcome
Outcome
TimePoints
Not Applicable
Not Applicable
Target Sample Size
Total Sample Size="1272" Sample Size from India="1272" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
is a prospective, interventional study to develop a library through smartphone-based
App. Identified asthmatic and
non-asthmatic subjects will be screened for the study after written and signed
informed consent is obtained and as per the eligibility criteria, will be
enrolled into the study. Demography & medical data will be collected.
Sounds generated on forceful oral exhalation will be recorded on a smartphone-based
App.