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Study to create a library of signals generated by asthmatic and non-asthmatic subjects through a smartphone-based App to estimate lung health

A prospective, interventional study to develop a library of signals generated on forceful oral exhalation by asthmatic and non-asthmatic subjects through a smartphone-based App - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067343
Enrollment
1272
Registered
2024-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: J459- Other and unspecified asthma

Interventions

Intervention1: SMARTPHONE-BASED HEALTHCARE APP (SOFTWARE AS MEDICAL DEVICE): Development of a library of signals generated on forceful oral exhalation by asthmatic and non-asthmatic subjects Control I

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA FOR ASTHMATIC SUBJECTS 1. Subjects providing consent for capturing and sharing their details. 2. Adults of any gender with age of 18 years and above. 3. Prior diagnosis of asthma or pulmonologist confirmed asthma. INCLUSION CRITERIA FOR NON-ASTHMATIC SUBJECTS 1. Subjects providing consent for capturing and sharing their details 2. Adults of any gender with age of 18 years and above. 3. Non-Asthmatic subjects with following criteria (all criteria have to be met) i. No respiratory symptoms viz breathlessness, cough, wheezing, chest tightness ii. No previous diagnosis of any lung disorder iii. No family history of asthma/allergy iv. No use of medication for lung disorder

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA FOR ASTHMATIC SUBJECT 1. H/o hernia, abdominal surgery or cardio-pulmonary surgery 2. Any recent asthma exacerbation or hospitalization 3. Subjects who are cognitively challenged or have psychological disorders. 4. H/o COPD, bronchiectasis, interstitial lung disease, cystic fibrosis, pulmonary hypertension and tuberculosis. 5. H/o pneumothorax, ventilatory support, severe respiratory distress, structural upper airway disease. 6. H/o breathlessness due to heart disease, anaemia, pneumonia. 7. Any active respiratory infection 8. As per investigator’s discretion subject is not able to blow forcefully EXCLUSION CRITERIA FOR NON-ASTHMATIC SUBJECTS 1. H/o hernia, abdominal surgery or cardio-pulmonary surgery 2. Any recent asthma exacerbation or hospitalization 3. Subjects who are cognitively challenged or have psychological disorders. 4. H/o COPD, bronchiectasis, interstitial lung disease, cystic fibrosis, pulmonary hypertension and tuberculosis. 5. H/o pneumothorax, ventilatory support, severe respiratory distress, structural upper airway disease. 6. H/o breathlessness due to heart disease, anaemia, pneumonia. 7. Any active respiratory infection 8. As per investigator’s discretion subject is not able to blow forcefully

Design outcomes

Primary

MeasureTime frame
Library of signals generated on forceful oral exhalation to develop health related cut-off values for Asthmatic and Healthy volunteers.Timepoint: Single Day Visit.

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

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