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Multicentre, Single Visit, Outpatient, Non Interventional, Observational Study involving Indian patient with Asthma

Study to estimate the prevalence of small Airways dysfunction Across all severities of Asthma using Impulse Oscillometry in Indian Patients with Asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/031108
Enrollment
100
Registered
2021-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: J984- Other disorders of lung

Interventions

None listed

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children and adult male or female patients within 12 to 60 years of age 2. Physician diagnosed asthma according to GINA guidelines and documented airflow limitation 3. Treatment naïve as well as patients on treatment 4. Able to comply with study requirement in the opinion of the investigator

Exclusion criteria

Exclusion criteria: 1. Patients who have participated in interventional clinical study in the last 2 months 2. Patients who are contraindicated from performing spirometry based on a recent surgery history. 3. Patients with documented history of idiopathic haemoptysis, active lung infection any syncope associated with forced exhalation 4. Abnormal baseline findings considered by Investigator to indicate conditions that might affect study endpoints 5. Patients with acute infection being treated with intravenous antibiotics. 6. Any other condition that, in the investigator judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory information needed to achieve the objectives of the study

Design outcomes

Primary

MeasureTime frame
To estimate the prevalence of small airways dysfunction across all severities of asthma using IOSTimepoint: IOS compared to Spirometry. Single visit study

Secondary

MeasureTime frame
To correlate various IOS parameter with spirometry parameter pre and post administration of the bronchodilator To correlate various IOS parameters with level of asthma control measured by ACQ 5 This is an observational study to understand prevalence of asthma using IOSTimepoint: IOS compared to Spirometry. This is a single visit study

Countries

India

Contacts

Public ContactDr Ambar Vaidya

PhaseON Clinical Research Pvt. Ltd.

Kalpana.sharma@phaseon-clinical.com9979724293

Outcome results

None listed

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