| CTRI Number |
CTRI/2026/02/104698 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mobile Application Using Peak Expiratory Flow Rate to Guide Asthma Treatment. |
|
Scientific Title of Study
|
Peak Expiratory Flow Rate -(PEFR)-An App For Asthma Treatment Titration. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishnu Rs |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department Of Respiratory Medicine,Saveetha Medical College And Hospital,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai.
Department Of Respiratory Medicine,Saveetha Medical College And Hospital,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
7907213982 |
| Fax |
|
| Email |
vishnusivan3114@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanth G |
| Designation |
Associate Professor |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department Of Respiratory Medicine,Saveetha Medical College And Hospital,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai - 602105,
Tamil Nadu, India.
Department Of Respiratory Medicine,Saveetha Medical College And Hospital,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
9788852770 |
| Fax |
|
| Email |
prasanthgd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishnu Rs |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department Of Respiratory Medicine,Saveetha Medical College And Hospital,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai.
Department Of Respiratory Medicine,Saveetha Medical College And Hospital,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
07907213982 |
| Fax |
|
| Email |
vishnusivan3114@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College And Hospitals,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai - 602105,
Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College And Hospitals. |
| Address |
Saveetha Medical College And Hospitals,Saveetha Nagar, Thandalam, Chennai Bangalore, NH 48, Chennai - 602105, Tamil Nadu, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vishnu Rs |
Saveetha Medical College And Hospital. |
Department Of Respiratory Medicine,Saveetha Medical College And Hospital,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai - 602105,
Tamil Nadu, India.
Saveetha Medical College And Hospital,Saveetha Nagar, Thandalam,
Chennai Bangalore, NH 48,
Chennai.
Chennai
TAMIL NADU |
07907213982
vishnusivan3114@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College And Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J980||Diseases of bronchus, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
PEFR-Guided Asthma Treatment Titration Using a Mobile Application. |
The intervention involves a Peak Expiratory Flow Rate (PEFR)–based asthma treatment titration mobile application that enables patients to record daily PEFR values and symptoms, which are automatically compared to their personal best to categorize control into green, yellow, or red zones. Based on these zones, the app provides algorithm-driven, guideline-aligned recommendations for stepping up or stepping down therapy, such as adjusting inhaled corticosteroid doses, adding bronchodilators, or initiating rescue measures during exacerbations. It integrates symptom tracking, medication reminders, graphical trend analysis, and automated alerts for deterioration, while also allowing clinician access to monitor progress remotely. This digital, objective-monitoring approach facilitates early detection of worsening airflow limitation, improves treatment precision, enhances adherence, and aims to reduce exacerbations and healthcare utilization through structured, personalized asthma self-management. |
| Comparator Agent |
Standard Asthma Care with Conventional Monitoring. |
Participants in the comparator arm will receive standard asthma care as per prevailing clinical practice and guideline recommendations. Asthma management will be based on symptom assessment, reliever use, and periodic clinical evaluation, with treatment adjustments made during routine outpatient visits. Lung function assessment, including PEFR or spirometry, will be performed only during scheduled clinic visits and not used for daily home-based treatment titration.
Patients in the comparator group will be managed using a conventional written asthma action plan, without the use of a mobile application, automated alerts, or real-time PEFR-guided decision support. Education regarding inhaler technique and trigger avoidance will be provided as part of routine care, but no digital monitoring or app-based feedback will be employed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 to 65 years
2.Clinically diagnosed bronchial asthma as per standard guidelines
3.Patients on regular controller therapy for asthma
4.Ability to perform acceptable and reproducible PEFR measurements
5.Ownership of and ability to use a smartphone capable of running the study application
6.Willingness to use the mobile application and perform daily PEFR recordings |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years or more than 65 years
2.Acute severe asthma exacerbation requiring immediate hospitalization at enrollment
3.Coexisting chronic respiratory diseases (e.g., COPD, bronchiectasis, interstitial lung disease)
4.Significant smoking history
5.Inability to perform reliable PEFR maneuvers despite instruction
6.Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in asthma control measured by change in Asthma Control Test (ACT) score from baseline to the end of follow-up. |
1st month, 2nd month, 3rd month, 4th month, 5th month, 6th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.PEFR variability and zone control (mean PEFR, % days in green/yellow/red zone)
2.Asthma exacerbations and OCS use
3.Reliever (SABA) use 4.Medication adherence
5.Inhaler technique
6.Quality of life (AQLQ) |
1st month, 2nd month, 3rd month, 4th month, 5th month, 6th month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study evaluates the effectiveness of a PEFR-based mobile application for asthma treatment titration. Patients with physician-diagnosed asthma are enrolled and provided access to the app, which enables daily PEFR recording, automatic categorization into green, yellow, or red zones based on personal best values, and algorithm-guided treatment titration in accordance with standard asthma action plans. Baseline demographic data, asthma severity, and initial lung function parameters are recorded before intervention.Participants are followed up over a predefined period, during which changes in asthma control, exacerbation frequency, treatment adjustments, and healthcare utilization are assessed. The study compares outcomes before and after app-based PEFR-guided titration, focusing on improvements in objective airflow control, timely treatment escalation, and patient self-management, thereby evaluating the clinical utility of digital PEFR-guided asthma care. |