| CTRI Number |
CTRI/2026/04/108417 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Which Nebuliser Works Better During a COPD Attack. |
|
Scientific Title of Study
|
Comparison Of The Clinical Outcome of Nebulized Formoterol plus Budesonide versus Neblized salbutamol plus Budesonide in acute exacerbation of COPD. (AECOPD) Presenting in the Pulmonary Department, Peoples Hosppital, Bhopal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Waquar Yunus |
| Designation |
Post Graduate Student |
| Affiliation |
Peoples College Of Medical Science And Research Centre |
| Address |
Junior Resident Dept Of Respiratory Medicine Third Floor
D Block People Hospital Bhopal
Peoples Campus Ayodhya Bypass Road Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7004806369 |
| Fax |
|
| Email |
wqrns7@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tandon |
| Designation |
Professor |
| Affiliation |
Peoples College Of Medical Science And Research Centre |
| Address |
3rd Floor Block D
Dept Of Respiratory Medicine Peoples Hospital, Peoples Campus Ayodhya Bypass Road Bhanpur Bhopal
Peoples Campus Ayodhya Bypass Road Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9425030369 |
| Fax |
|
| Email |
sanjay2011@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tandon |
| Designation |
Professor |
| Affiliation |
Peoples College Of Medical Science And Research Centre |
| Address |
3rd Floor Block D Dept Of Pulmonary Medicine Peoples Hospital, Peoples Campus Ayodhya Bypass Road Bhanpur Bhopal
Peoples Campus Ayodhya Bypass Road Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9425030369 |
| Fax |
|
| Email |
sanjay2011@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PEOPLES COLLEGE OF MEDICAL SCIENCE AND RESEARCH CENTRE BHOPAL |
|
|
Primary Sponsor
|
| Name |
DR WAQUAR YUNUS |
| Address |
ROOM T5 PG BOYS HOSTEL PEOPLES CAMPUS BHANPUR BHOPAL |
| Type of Sponsor |
Other [SELF] |
|
|
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 Waquar Yunus |
Peoples Hospital |
3rd Floor D Block Peoples Hospital Ayodhya Bypass Rd, Peoples Campus, Bhanpur, Bhopal, Madhya Pradesh 462037
Bhopal
MADHYA PRADESH |
7004806369
wqrns7@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Formoterol + Budesonide |
Patient Receiving combination therapy of Long Acting Beta agonist with Inhaled corticosteroid administered via Nebulisation as per Treating Physician |
| Comparator Agent |
Salbutamol + Budesonide |
Patient Receiving Short Acting Beta Agonist with Inhaled corticosteroid given Via Nebulisation. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. More than equal to 40 year
2. Known Case Of COPD
3. Presenting with Acute Exacerbation of COPD |
|
| ExclusionCriteria |
| Details |
branchial Asthma
active PTB
Primary Pneumonia
Hemodynamic instability
Known Hypersensitivity to LABA or SABA
Pregnant or Lactating women
Patient who Refuse Consent
Ventilated Patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the Improvement in Oxygen Saturaion.
Reduction Of Breathlessness
2hr,6hr,12hr,24 hr and Discharge . |
During Course Of Treatment and At the Time Of Discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the Duration Of Hospital Stay in Both Group.
Need For NIV Need ICU Transfer & ADR |
During Course of treatment & AT the Time of Discharge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/04/2026 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included nil).
- For how long will this data be available start date provided 01-09-2027 and end date provided 31-08-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
nil |