Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Cipla, pneumotach sensor based Spirometer: Pneumotach sensor based spirometer to be used for office spirometry in clinics for diagnosis of Asthma and COPD.
Control Intervention1: Vitalo
Sponsors
Cipla Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 ââ?°Â¥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 ââ?¬â?? B 8. COVID-19 test report negative within the last 24 to 48 hours or as per site instituteââ?¬•s policy and free from any active symptoms suggestive of COVID-19
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: Difference of 1 hour | — |
Secondary
| Measure | Time frame |
|---|---|
| Delta FVC and FEV1 between the two SpirofyTM devices in healthy, asthmatic and COPD SubjectsTimepoint: Difference of 1 hour | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Ltd
Outcome results
None listed