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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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