| CTRI Number |
CTRI/2021/09/036492 [Registered on: 14/09/2021] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Device Comparative Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between the SpirofyTM Spirometer newly developed by Cipla Ltd. with an existing Spirometer (Vitalograph Alpha Touch Spirometer) in healthy, asthmatic and COPD Subjects |
|
Scientific Title of Study
|
A randomized, open-label, three-way crossover study to
validate the SpirofyTM device (Cipla, pneumotach sensorbased spirometer) by comparing two SpirofyTM devices
with the reference Vitalograph Alpha Touch standard
spirometer (pneumotach sensor-based conventional
spirometer) in healthy, asthmatic and COPD subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/15/20 |
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 MAHARASHTRA India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
022-23035333 |
| Fax |
|
| Email |
jgogtay@cipla.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Sawant |
| Designation |
Head of Clinical Trails |
| Affiliation |
Cipla Ltd |
| Address |
Dept: Medical Services
Division: Clinical Trials
Room No: NA Cipla Ltd. 289, Bellasis Road Mumbai Central
Mumbai. MAHARASHTRA
NA
Mumbai
MAHARASHTRA
400008
India |
| Phone |
022-23025188 |
| Fax |
|
| Email |
sandesh.sawant3@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Abhijit Vaidya |
| Designation |
Senior Manager Clinical Trials |
| Affiliation |
Cipla Ltd |
| Address |
Dept: Medical Services Division: Clinical Trials
Room No. NA Cipla Ltd. 289, Bellasis Road
Mumbai Central
Mumbai. India
NA
Mumbai
MAHARASHTRA
400008
India |
| Phone |
022-23025145 |
| Fax |
|
| Email |
abhijit.vaidya@cipla.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India |
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Cipla Ltd.,
289, Bellasis
Road,
Opposite Sahil
Hotel,
Mumbai Central
East,
Mumbai,
Maharashtra
400008 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Talwar |
Metro Hospitals and Heart Institute, Noida, India |
Department: Metro Center for Respiratory Diseases, Division: Respiratory, Room No: 3rd Floor (Complete Floor) X 1, SECTOR 12, NOIDA,
201301
Gautam Buddha Nagar
UTTAR PRADESH |
9899050000
dtlung@hotmail.com |
| Dr Mahavir Modi |
Modi Clinic Excellence in Chest and ENT |
Bungalow Number:61-A
Department of Chest;
Modi Clinic Excellence in Chest and ENT; Raksha Lekha Society; Near Dhanakwadi Post Office, Dhanakwadi,411043
Pune
MAHARASHTRA |
9822253596
drm_modi@yahoo.co.in |
| Dr S Balamurugan |
Sri Muthukumaran Medical College and Research Institute, Chennai |
Room no: 112, 1st Floor, Department of Pulmonary Medicine, Sri Muthukumaran Medical College, Chikkarayapuuram, Mangadu, Chennai,600069
Chennai
TAMIL NADU |
9600002646
dr.s.bala@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Muthukumaran Medical College, Chikkarayapuuram, Mangadu, Chennai,600069 |
Approved |
| Institutional Ethics Committee, Sri Muthukumaran Medical College, Chikkarayapuuram, Mangadu, Chennai,600069 |
Approved |
| Metro Ethical Review Board, Metro Hospitals and Heart Institute, Sec-11, Noida |
Approved |
| Metro Ethical Review Board, Metro Hospitals and Heart Institute, Sec-11, Noida |
Approved |
| Royal Pune Independent Ethics Committee, Office No. 13, Srv No. 84/1A, Anupam arcade, Pune Satara Road, Pune 411046 |
Approved |
| Royal Pune Independent Ethics Committee, Office No. 13, Srv No. 84/1A, Anupam arcade, Pune Satara Road, Pune 411046 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects meeting the below mentioned criteria will be enrolled in the study:
1. Healthy subjects or stable asthma patients or stable COPD patients
2. Age ≥18 years
3. Medical history / medical records showing evidence of diagnosed asthma or COPD for
these patients.
4. No history of exacerbations of any disease since last 4 weeks
5. No active or chronic respiratory complaints, normal clinical examination and normal
spirometry for healthy individuals.
6. No history of upper or lower respiratory tract infection since last 4 weeks
7. Subjects able to perform spirometry in accordance to 2019 ATS/ERS criteria with a
grading between A – B
8. COVID-19 test report negative within the last 24 to 48 hours or as per site institute’s
policy and free from any active symptoms suggestive of COVID-19 |
|
| ExclusionCriteria |
| Details |
1. Significant lung/airway diseases other than the asthma or COPD diagnosis for each of
the subject groups
2. Any contraindications for spirometry as per ATS/ERS 2019 Guidelines as mentioned in
section 4.4 of the protocol.
3. Any significant deformity of the thorax or vertebral column that may cause persistent
airflow limitation or altered lung volumes
4. Uncontrolled or unstable asthma / COPD status in the subjects
5. Severe concomitant disease which may have an adverse impact on the spirometric
performance such as any unstable health conditions viz cardiovascular, pulmonary,
abdominal, neurological or any endocrine disorders
6. Female subject who is pregnant |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Primary End Point:
1. Delta FVC between SpirofyTM and Reference Vitalograph Alpha Touch spirometer in
healthy, asthmatic and COPD subjects
2. Delta FEV1 between SpirofyTM and Reference Vitalograph Alpha Touch spirometer in
healthy, asthmatic and COPD subjects
Co-Primary Endpoint :
1. Delta FEV1/FVC ratio 0.7 between SpirofyTM and Reference Vitalograph Alpha Touch spirometer in healthy, asthmatic and COPD subjects
|
Difference of 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Delta FVC and FEV1 between the two SpirofyTM devices in healthy, asthmatic and COPD Subjects |
Difference of 1 hour |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2021 |
| Date of Study Completion (India) |
25/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will recruit 90 participants from two sites in India. Study participants will be Healthy Volunteers (30) , and patients of asthma (30) and COPD (30). Only subjects who are COVID Negative on RTPCR within 24-48 hours of the study visit will be enrolled. It is a single visit study where the subject will be asked to perform spirometry tests in the three spirometers in random order. The difference in FVC and FEV1 between the Spirofy and the Vitalograph Spirometer will be the primary end point and comparison of variability between the two Spirofy Devices is the secondary end point. We will use acceptable limits of agreement in accordance to the ATS reproducibility standard for FVC and FEV1 (0.15 L), and for comparative purpose, previously described 95% limits of agreement for validity of 0.50 L for FVC and 0.35 L for FEV1 |