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A clinical study to compare readings between a digital versus mechanical peak flow meter device in healthy participants, asthmatic and COPD patients.

A randomized, open label, comparative, cross-over study to compare peak flow rate measurements of Cipla s digital peak flow meter with Cipla s mechanical peak flow meter in healthy participants, asthmatic and COPD patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084115
Enrollment
200
Registered
2025-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: J45- Asthma Health Condition 2: J44- Other chronic obstructive pulmonary disease

Interventions

Intervention1: Digital Peak Flow Meter 1 & Digital Peak Flow Meter 2: Digital peak flow meter device will be the intervention tested by recording peak flow meter readings displayed on electronic disp

Sponsors

Cipla Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntarily written signed dated Informed consent from participants. 2. Participants of either gender aged 18 years and above 3. Healthy participants [participants who do not have asthma or COPD or other pulmonary disease as per investigator discretion] or patients with a documented diagnosis of Asthma or COPD

Exclusion criteria

Exclusion criteria: 1. Participants who are unable to perform acceptable peak expiratory flow rate test. 2. Pregnant and lactating women. 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 or conditions which may have an adverse impact on the performance of peak expiratory flow meter such as any unstable health conditions viz cardiovascular, pulmonary, abdominal, neurological or recent surgeries.

Design outcomes

Primary

MeasureTime frame
To compare peak flow rate measurements of Cipla s digital peak flow meter (PFM) with Cipla s mechanical PFM.Timepoint: Single Visit—

Secondary

MeasureTime frame
To assess the inter-device variability of Cipla s digital PFM.Timepoint: Single Visit—

Countries

India

Contacts

Public ContactDr Sonali Karekar

Cipla Ltd.

sandesh.sawant3@cipla.com02223025006

Outcome results

None listed

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