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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.

A randomized, open-label, three side crossover study investigator initiated study to validate the i-Spiro (Cipla) by comparing Cipla Pneumotach sensor based spirometer and Koko spirometer (pneumotach sensor which is based on conventional spirometer) in healthy adult subjects, adult patients having asthma and adult patients having Chronic Obstructive Pulmonary Disease (COPD). - iSpiro Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/08/020738
Enrollment
81
Registered
2019-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: J459- Other and unspecified asthma

Interventions

None listed

Sponsors

Chest Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No significant difference in inter test and intra test values obtainedTimepoint: 24 hours—

Countries

India

Contacts

Public ContactDr Komalkirti Apte

Chest Research Foundation

drkomalapte@crfindia.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026