| CTRI Number |
CTRI/2025/09/094687 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two types of inhalers for children and teenagers with asthma |
|
Scientific Title of Study
|
Comparing the clinical efficacy of
breath actuated inhalers versus metered dose inhalers with spacer in children and
adolescents with asthma |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tamanna Sharma |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Pediatrics Government medical college and hospital Chandigarh Sector 32 Chandigarh 160030
Chandigarh CHANDIGARH 160030 India |
| Phone |
9914934860 |
| Fax |
|
| Email |
tamanna1306sharma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivani Randev |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Pediatrics Government medical college and hospital Chandigarh Sector 32 Chandigarh 160030 Department of Pediatrics Government medical college and hospital Chandigarh Sector 32 Chandigarh 160030 Chandigarh CHANDIGARH 160030 India |
| Phone |
9914201318 |
| Fax |
|
| Email |
shivanirandev@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tamanna Sharma |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Pediatrics Government medical college and hospital Chandigarh Sector 32 Chandigarh 160030
Chandigarh CHANDIGARH 160030 India |
| Phone |
9914934860 |
| Fax |
|
| Email |
tamanna1306sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE AND HOSPITAL CHANDIGARH
Department of Pediatrics Sector 32 Chandigarh India 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Pediatrics Government Medical college and hospital Sector 32 Chandigarh 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Tamanna Sharma |
Government Medical College & Hospital, Chandigarh |
Department of Pediatrics Government medical college and hospital Chandigarh Sector 32 Chandigarh 160030 Chandigarh CHANDIGARH |
09914934860
tamanna1306sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J45||Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breath actuated inhaler |
The Synchro Breathe
is a type of breath-actuated metered-dose inhaler (BA-MDI) designed to release medication
automatically upon detecting an inhalation effort for 18 months |
| Comparator Agent |
Metered dose inhaler |
Metered Dose
Inhalers (MDIs) used with spacers have drawbacks They add size making them less convenient to carry older
children may feel embarrassed to use them in front of other people they may be difficult to assemble and use by children on their own needing adult assistance These drawbacks may
reduce drug compliance leading to poor control of symptoms |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 to 18 years with asthma diagnosed according to criteria in GINA 2024
Only patients requiring daily inhaled corticosteroids as controller |
|
| ExclusionCriteria |
| Details |
Acute exacerbation at enrolment
Comorbid conditions affecting lung function eg cystic fibrosis ABPA
Unable to perform spirometry
Patients unlikely or unwilling to come for followup visits as planned |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in FEV1 percent of expected from baseline |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with asthma controlled, partly controlled or uncontrolled |
2 4 12 weeks |
| Change in PEFR from baseline |
2 4 12 weeks |
| Proportion of missed doses in previous 4 weeks |
4 weeks |
| Proportion of steps correctly performed |
2 4 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
23/09/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Asthma is a major cause of disease burden in Asian children including India where its prevalence is 7.9 percent. Despite therapeutic advances asthma control remains poor especially in low and middle income countries due to limited access to care. Inhaled medications like corticosteroids are key to treatment but effectiveness depends on proper inhaler technique. Metered Dose Inhalers MDIs with spacers are commonly recommended for children but have drawbacks including bulkiness and stigma which may reduce adherence. Breath actuated inhalers BAIs such as Synchro Breathe may improve drug delivery by removing the need for hand breath coordination. However their efficacy in children particularly in India is not well studied.
This randomized controlled trial will compare BAIs and MDIs with spacers in children aged 6 to 18 years at a tertiary hospital in Chandigarh. A total of 70 children will be enrolled and stratified by age. Both groups will receive identical drug formulations. Lung function FEV1 spirometry patient diaries and validated questionnaires will be used. The findings aim to provide evidence based guidance for selecting the most effective and user friendly inhaler devices for pediatric asthma management in resource limited settings. |