An investigator initiated study to study how well does a newly developed spirometer by Cipla Ltd. work as compared to the spirometer already available in the market.
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J459- Other and unspecified asthma
- Registration Number
- CTRI/2019/08/020738
- Lead Sponsor
- Chest Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy subjects or stable asthma patients or stable COPD patients
2.Subjects >18 years
3.Medical history / medical records for evidence of asthma and COPD
1.Acute exacerbation of bronchial asthma or COPD or hospitalization/emergency room visits due to asthma/COPD exacerbation within the last 6 weeks prior to study participation
2.History of any Abdominal/Thoracic surgery in the last 1 month
3.Any eye surgery in the last 1 month
4.Uncontrolled or unstable asthma and COPD status in the subjects
5.Severe concomitant disease which may have an 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 Difference in FVC and FEV1 value measured by the Koko Spirometer and the iSPiro is not more than 500 ml and 350 ml respectively.Timepoint: 24 hours
- Secondary Outcome Measures
Name Time Method o significant difference in inter test and intra test values obtainedTimepoint: 24 hours