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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

Not Applicable
Conditions
Health Condition 1: J459- Other and unspecified asthma
Registration Number
CTRI/2024/05/067343
Lead Sponsor
Cipla Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ibrary of signals generated on forceful oral exhalation to develop health related cut-off values for <br/ ><br>Asthmatic and Healthy volunteers.Timepoint: Single Day Visit.
Secondary Outcome Measures
NameTimeMethod
ot ApplicableTimepoint: Not Applicable
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