Comparison between the SpirofyTM Spirometer newly developed by Cipla Ltd. with an existing Spirometer (Vitalograph Alpha Touch Spirometer) in healthy, asthmatic and COPD Subjects
- Conditions
- Healthy Human VolunteersChronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J459||Other and unspecified asthma,
- Registration Number
- CTRI/2021/09/036492
- Lead Sponsor
- Cipla Limited
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
- 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.
- 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.
- 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary End Point: Difference of 1 hour 1. Delta FVC between SpirofyTM and Reference Vitalograph Alpha Touch spirometer in Difference of 1 hour healthy, asthmatic and COPD subjects Difference of 1 hour 2. Delta FEV1 between SpirofyTM and Reference Vitalograph Alpha Touch spirometer in Difference of 1 hour Co-Primary Endpoint : Difference of 1 hour 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 Measures
Name Time Method Delta FVC and FEV1 between the two SpirofyTM devices in healthy, asthmatic and COPD Subjects Difference of 1 hour
Trial Locations
- Locations (3)
Metro Hospitals and Heart Institute, Noida, India
🇮🇳Nagar, UTTAR PRADESH, India
Modi Clinic Excellence in Chest and ENT
🇮🇳Pune, MAHARASHTRA, India
Sri Muthukumaran Medical College and Research Institute, Chennai
🇮🇳Chennai, TAMIL NADU, India
Metro Hospitals and Heart Institute, Noida, India🇮🇳Nagar, UTTAR PRADESH, IndiaDr Deepak TalwarPrincipal investigator9899050000dtlung@hotmail.com