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CTRI Number  CTRI/2025/04/084084 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 02/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The usefulness of blood eosinophil count-based steroid therapy in the treatment of acutely worsening patients with chronic obstructive pulmonary disease: Randomized Controlled Trial 
Scientific Title of Study   Impact Of Eosinophil-Based Corticosteroid Therapy On Treatment Success And Adverse Events In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial  
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 Kartikeya Kumar Sharma 
Designation  Senior resident, Pulmonary, Critical Care and Sleep medicine 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 9, Department of Pulmonary, Critical care and Sleep Medicine, AIIMS,New Delhi

New Delhi
DELHI
110049
India 
Phone  8770193890  
Fax    
Email  kartikeya.arjun@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Hadda 
Designation  Professor, Pulmonary, Critical Care and Sleep medicine 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 8, Department of Pulmonary, Critical care and Sleep Medicine, AIIMS,New Delhi

New Delhi
DELHI
110049
India 
Phone  9868883208  
Fax    
Email  vijayhadda@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Kartikeya Kumar Sharma 
Designation  Senior resident, Pulmonary, Critical Care and Sleep medicine 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 9, Department of Pulmonary, Critical care and Sleep Medicine, AIIMS,New Delhi

New Delhi
DELHI
110049
India 
Phone  8770193890  
Fax    
Email  kartikeya.arjun@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India Pincode : 110029  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India Pincode 110029 
Type of Sponsor  Research institution and hospital 
 
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 Kartikeya Kumar Sharma  All India Institute of Medical Sciences, New Delhi  Department of Pulmaonry Medicine, Third Floor, New Pvt ward, AIIMS, Ansari Nagar East, New Delhi, 110029
New Delhi
DELHI 		 8770193890

kartikeya.arjun@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Eosinophil guided corticosteroid therapy group (EGT)   Inj. Hydrocortisone 200 mg will be given on Day 1. Therafter, Based on eosinophil count, patient will receive Inj. Hydrocortisone 50 mg TDS if AEC is more than 300 or Eosinophil % is more than 2 %. Lesser than threshold eosinophil will not receive systemic corticosteroid therapy , and high dose inhaled budesonide ( 2 mg TDS ) will be continued. 
Comparator Agent  Standard Care Therapy arm ( SCT)   i.v Hydrocortisone 200 mg on Day 1 followed by Inj. Hydrocortisone 50 mg TDS for 5 days, regardless of eosinophil count.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients with Clinician diagnosed COPD, and hospitalised due to AECOPD
2. Moderate to severe AECOPD diagnosis as defined by GOLD guidelines 2024, including those requiring HFNC, NIV or IMV
3. Signed informed consent
 
 
ExclusionCriteria 
Details  Known diagnosis of bronchial asthma
Use of systemic corticosteroids for more than one week in the last 12 weeks
More than 36 hours of systemic steroid usage during the current exacerbation
Patients fit for discharge within 24 hours of admission or emergency visit
Those with contraindications to systemic steroids, or those requiring systemic steroids for alternate indications such as adrenal insufficiency
Pregnancy or lactation, severe mental illness
Other systemic causes of eosinophilia
Recent or current myocardial infarction
Active pulmonary tuberculosis
Post-tubercular or post-infective obstructive pulmonary disease with extensive scarring sequelae
Active malignancy
Systemic fungal infections
Septic shock
Life expectancy of less than 30 days 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The rate of treatment success in the combination (Eosinophil guided systemic steroid plus high dose inhaled corticosteroid) arm therapy as compared to daily systemic corticosteroid therapy on Day 14  Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
Composite of adverse outcomes (Mortality , Prolonged hospital/ICU stay, ,COPD re-exacerbation leading to ER visits, re-admittance to hospital   Day 14 and 28  
Length of ICU and hospital stay  Day of Transfer out of ICU
Day of discharge
From randomisation 
All-cause mortality rate  Day 28 and Day 90 
Cumulative corticosteroid dosage  baseline, Day 14, and Day 28 
 
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   Phase 3 
Date of First Enrollment (India)   14/04/2025 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kartikeya.arjun@gmail.com].

  6. For how long will this data be available start date provided 25-04-2025 and end date provided 25-02-2032?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Although systemic corticosteroids for 5 days is the standard of therapy for AECOPD, recent evidence suggest corticosteroids may be more beneficial in eosinophilic subset of COPD exacerbations, while may cause more harm in non-eosinophilic exacerbations. This study aims to give biomarker-guided therapy based on raised eosinophils and reduce cumulative dose and adverse effects of corticosteroids. The study aims to determine whether eosinophil guided steroid therapy combined with high dose inhaled corticosteroids is comparable to daily systemic corticosteroid therapy in terms of treatment success rates in hospitalised patients with acute exacerbation of COPD.

 
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