Comparison between the SpirofyTM Spirometer newly developed by Cipla Ltd. with an existing Spirometer (Vitalograph Alpha Touch Spirometer) in healthy, asthmatic and COPD Subjects

Not Applicable

Completed

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

• Registration Number: CTRI/2021/09/036492
• Lead Sponsor: Cipla Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-25
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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 �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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified