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CTRI Number  CTRI/2025/07/091701 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to understand the impact of appropriate inhaler use and following the correct treatment as prescribed on asthma control in asthma patients. 
Scientific Title of Study   Patient and Treatment related barriers in Management of Asthma – A Cross-Sectional Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namita Honnutagi 
Designation  Junior Resident 
Affiliation  Kasturba Medical College 
Address  Department of Pharmacology, Kasturba Medical College, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880981696  
Fax    
Email  namitagh7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharti Chogtu Magazine 
Designation  Professor and HOD 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Pharmacology, KMC, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901728668  
Fax    
Email  bharti.magazine@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Namita Honnutagi 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Pharmacology, Kasturba Medical College, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880981696  
Fax    
Email  namitagh7@gmail.com  
 
Source of Monetary or Material Support  
Department of Respiratory Medicine, Kasturba Medical College, Manipal, Karnataka, India 576104 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba Medical College, Manipal, Karnataka, India 576104 
Type of Sponsor  Private 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 Namita Honnutagi  Kasturba Medical College, Manipal  Room No-16,1st Floor, Department of Respiratory Medicine, Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA 		 9880981696

namitagh7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC-KH Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J455||Severe persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients diagnosed with asthma (as per GINA criteria).
On inhaler therapy for at least 6 months.
Willing to provide informed consent.
Both outpatients and inpatients of asthma.
 
 
ExclusionCriteria 
Details  Patients with other chronic respiratory diseases other than asthma.
Unwilling or unable to complete questionnaire.
Patients with language or psychiatric problems that would affect their ability to answer questions.
Patients receiving inhalational therapy for other diseases.
Patients using only oral therapy (i.e., not on inhalers).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Appropriateness of prescribed asthma treatment based on 2025 GINA guidelines, along with symptom severity.
•Level of adherence to asthma medication using the Morisky Medication Adherence Scale (MMAS-4) as: Good/Moderate/Low adherence.
•Quantitative measurement of adherence to inhalers using the TAI questionnaire, which will help classify adherence as: Good adherence/ Intermediate adherence/ Poor or non-adherence. 		 Being a cross sectional observational study, the outcomes will be assessed/ estimated only at a single time interval, i.e., at baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients demonstrating correct vs. incorrect inhaler technique based on checklists for each device type (MDI, DPI, etc.).  Being a cross sectional observational study, the outcomes will be assessed/ estimated only at a single time interval, i.e., at baseline. 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   15/08/2025 
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="4"
Days="15" 
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 will be conducted among patients aged 18 years and above, who have been using any type of inhaler device for at least 6 months visiting the center for the symptomatology or the follow up of asthma. Data will be collected following approval from the Institutional Ethics Committee.

  1. Eligible patients will be identified during routine outpatient or inpatient visits.
  2. After informed consent, each patient will be interviewed and assessed in a private setting.
  3. The following will be completed for each participant:
    • Sociodemographic and clinical data entry
    • GINA-based severity assessment
    • ACT questionnaire
    • MGLS and TAI for adherence evaluation
    • Direct observation of inhaler technique using device-specific checklists
  1. The entire interaction will take approximately 25–30 minutes per patient and done in a single visit.
  2. Common errors in inhaler use and patterns of non-adherence will be documented.
 
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