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A Study To Compare Cipla’s Oscillometer With The Tremoflo C-100 oscillometer in Healthy Participants, Asthmatic And COPD Patients.

A Randomized, Open Label, Comparative, Cross-Over, Multicentre Study To Compare Oscillometry Measurements Of Cipla’s Oscillometer With The Reference Device Tremoflo C-100 In Healthy Participants, Asthmatic And COPD Patients - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073954
Enrollment
150
Registered
2024-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Intervention1: Cipla’s Oscillometry Device: Impulse Oscillometry -is a Diagnostic Modalities (As a Medical Diagnostic Device) Control Intervention1: Tremoflo C-100: Impulse Oscillometry -is a Diagnost

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntarily given written signed dated Informed consent from participants. 2. Participants of either gender of age between 18 years to 75 years (both inclusive). 3. Healthy participants [participants who do not have asthma or COPD or other pulmonary disease as per investigator discretion] or documented diagnosis of Asthma or COPD which is confirmed by Spirometry.

Exclusion criteria

Exclusion criteria: 1. Participants who are unable to perform acceptable Oscillometry and/or Spirometry. 2. Pregnant and lactating women. 3. Significant lung/airway diseases other than the asthma or COPD diagnosis for each of the subject groups. 4. Any significant deformity of the thorax or vertebral column that may cause persistent airflow limitation or altered lung volumes. 5. Uncontrolled or unstable asthma / COPD status in the subjects. 6. Severe concomitant disease or conditions which may have an adverse impact on the performance of oscillometry or spirometry such as any unstable health conditions viz cardiovascular, pulmonary, abdominal, neurological or any endocrine disorders or recent surgeries.

Design outcomes

Secondary

MeasureTime frame
Comparison of the impedance (resistance and reactance) between the two Cipla Oscillometry devices 1 and 2 in healthy participants, asthmatic and COPD patients.Timepoint: Single day.—

Primary

MeasureTime frame
Comparison of the impedance (resistance and reactance) between Cipla’s Oscillometry Device 1 and 2 versus the reference device Tremoflo C-100 in healthy participants, asthmatic and COPD patients.Timepoint: Single Day—

Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Limited

sandesh.sawant3@cipla.com02223025006

Outcome results

None listed

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