| CTRI Number |
CTRI/2025/08/093819 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case cross over study |
| Study Design |
Other |
|
Public Title of Study
|
To find out association between air quality and asthma exacerbations in children 5-15 years of age |
|
Scientific Title of Study
|
Association between air quality index parameters and asthma exacerbations in children between 5-15 years of age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Paediatrics Maulana azad medical college and associated Lok nayak hospital New delhi
Central
DELHI
110002
India |
| Phone |
8851769196 |
| Fax |
|
| Email |
sakshilathar786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Kumar |
| Designation |
Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Paediatrics Maulana azad medical college and associated Lok nayak hospital New delhi
Central
DELHI
110002
India |
| Phone |
9211377848 |
| Fax |
|
| Email |
deepakk70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Kumar |
| Designation |
Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Paediatrics Maulana azad medical college and associated Lok nayak hospital New delhi
Central
DELHI
110002
India |
| Phone |
9211377848 |
| Fax |
|
| Email |
deepakk70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics Maulana azad medical college and associated Lok nayak hospital New delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Department of pediatrics |
| Address |
Maulana Azad medical College and associated lok nayak hospital new delhi 110002 |
| 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 Sakshi |
Lok nayak hospital |
Department of Paediatrics Mauna Azad Medical College and associated Lok Nayak Hospital New Delhi
Central
DELHI |
8851769196
sakshilathar786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5 years–15 years with a physician-diagnosed asthma
Adherent to Medications and using MDI correctly
Residing in Delhi-NCR for at least 6 months
School located within 5 km radius away from the home
|
|
| ExclusionCriteria |
| Details |
Children with other chronic respiratory diseases (bronchiectasis cystic fibrosis
Hospital visits for conditions unrelated to asthma exacerbations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of Air Quality Index with Frequency of hospital visits for asthma exacerbations |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of individual pollutants with frequency of hospital visits for asthma exacerbations
Correlation of cumulative air quality index of past three days & past seven days with frequency of hospital visits for asthma exacerbations
Correlation of temperature, humidity with frequency of hospital visits for asthma exacerbations |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/09/2025 |
| 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="0"
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 is an observational case crossover study aimed at finding the association between air quality index parameters and asthma exacerbations in children between five to fifteen years of age Study will be conducted at Maulana Azad medical College and associated lok nayak hospital delhi
Primary outcome will be Correlation of Air Quality Index with Frequency of hospital visits for asthma exacerbations
Secondary outcome of study will be
Correlation of individual pollutants with frequency of hospital visits for asthma exacerbations
Correlation of cumulative air quality index of past three days and past seven days with frequency of hospital visits for asthma exacerbations
Correlation of temperature humidity with frequency of hospital visits for asthma exacerbations |