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CTRI Number  CTRI/2025/09/094879 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 25/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the differences in the 2 treatments in various outcomes in patients who have been detected with chronic obstructive pulmonary disease (COPD) which is a lung disease and this disease is because of exposure to burning of cow-dung and wood. 
Scientific Title of Study   Exploring and comparing the effectiveness of initial Pharmacotherapy (ICS+LABA Vs LABA+LAMA) on Lung Outcomes in biomass–smoke-exposed COPD subjects 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
ARISE/EXPLOR/IIS/02/25_V3 dated 22/08/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sundeep Salvi 
Designation  Director 
Affiliation  Chest Research and Training (CREST) 
Address  Chest Research and Training Pvt Ltd. Sakore Nagar, Faith Centre. Viman nagar.Pune

Pune
MAHARASHTRA
411014
India 
Phone  9921211000  
Fax    
Email  sundeepsalvi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deesha Deepak Ghorpade 
Designation  Head, Academic Research 
Affiliation  Chest Research and Training (CREST) 
Address  Chest Research and Training Pvt Ltd. Sakore Nagar, Faith Centre. Viman nagar.Pune

Pune
MAHARASHTRA
411014
India 
Phone  9604643295  
Fax    
Email  deesha.ghorpade@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Deesha Deepak Ghorpade 
Designation  Head, Academic Research 
Affiliation  Chest Research and Training (CREST) 
Address  Chest Research and Training Pvt Ltd. Sakore Nagar, Faith Centre. Viman nagar.Pune

Pune
MAHARASHTRA
411014
India 
Phone  9604643295  
Fax    
Email  deesha.ghorpade@yahoo.in  
 
Source of Monetary or Material Support  
Cipla Pvt Ltd 
 
Primary Sponsor  
Name  Cipla Pvt Ltd 
Address  Cipla Limited Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400 013 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rennis Davis K  Amala Institute of Medical Sciences  Amala Nagar Thrissur 680555
Thrissur
KERALA 		 98474 85785

rennis@rediffmail.com 
Dr S Balamurugan  Chest and Diabetes Research Institute  Department and Division Pulmonary medicine Bungalow 2 First Cross Street Janaki Nagar Extension Valasaravakkam Chennai-600087
Chennai
TAMIL NADU 		 9600002646

dr.s.bala@gmail.com 
Dr Rajesh Swarnakar  Getwell Hospital and Research Institute  Department and Division Pulmonary medicine block 20/1 Dr Khare Marg Dhantoli Nagpur
Nagpur
MAHARASHTRA 		 98222 25130

drrajeshswarnakar@gmail.com 
Dr N Krithiga Lakshmi  Sri Muthukumaran Medical College Hospital and Research Institute  Chikkarayapuram, Near Mangadu, Chennai 600069
Chennai
TAMIL NADU 		 7639392348

kirthiganagarajan21@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Aurangabad Health Care and Research LLP Independent Ethics Comittee (Dr Suhas Bardapurkar)  Approved 
GETWELL INSTITUTIONAL (Dr Rajesh Swarnakar) ETHICS COMMITTEE (GIEC)  Approved 
HREC-AARC (Dr Indranil Halder)  Approved 
IEC AMLA INSTITUTE OF MEDICAL SCIENCES (Dr Rennis Davis)  Approved 
Institutional Ethics Comittee Chandan Hospital Lucknow (Dr Anil Kumar Singh)  Approved 
Institutional Ethics Committee SMMCH and RI (Dr Kirthigha)  Approved 
JSS Medical College.Institutional Ethical Comittee (Dr PA Mahesh)  Approved 
RIPON INDEPENDENT ETHICS COMMITTEE (RIEC) (Dr S Balamurugan)  Approved 
Sangini Hospital Ethics Comittee (Dr Kalpesh Panchal)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Formoterol 6mcg + Budesonide 200mcg   2 puffs BD through pMDI and Spacer 
Comparator Agent  Formoterol 6mcg + Glycopyronium 12.5mcg  2 puffs BD through pMDI and Spacer 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Age more than equal to 35 years
2 Gender Female and Male
3 Exposure to biomass fuel like wood Animal dung crop residues The Biomass Exposure Index BEI should be more than equal to 60 This index is calculated as the average hours spent on cooking per day multiplied by the number of years of cooking Accordingly patients can be recruited if they have a history of exposure such as 2 hours per day for 30 years 3 hours per day for 20 years or 4 hours per day for 15 years or any other exposure duration leading to a BEI of more than equal to 60
4 Symptoms Either one of the symptoms should be present Cough Shortness of breath Wheeze Chest tightness
5 Spirometry Post BD FEV1 by FVC more than 70 percentage and FEV1 percentage pred more than 80 percentage but less than 30 percentage. Spirometry will be conducted at screening for the naïve subjects and previously diagnosed cases of COPD Spirometry tests to be scheduled basis the time of the last inhaler taken in advance of the date of the test with appropriate instructions given to the patient for withholding the next dose and the time at which they need to report for the test
 
 
ExclusionCriteria 
Details  1 Subjects unwilling to sign the informed consent
2 Subjects unwilling to come for the follow up visits
3 BEI of less than 60
4 Subjects with a current diagnosis of Asthma or Bronchiectasis
5 Any form of tobacco smoking that is Bidis cigarettes hookahs chillum etc
6 History of Pulmonary TB treated and cured in the past
7 Subjects on current oral corticosteroids
8 Hypersensitivity to glycopyrronium or formoterol or budesonide or levosalbutamol or any of its components
9 Subjects with any hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening
10 Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening
11 Subjects requiring oxygen therapy at least 12 hours daily in past 4 weeks from screening
12 Clinically significant ECG abnormality
13 Clinically significant neurologic cardiovascular hepatic renal endocrine pulmonary post tuberculosis fibrosis pulmonary fibrotic disease pulmonary arterial hypertension hematologic psychiatric or other medical illness that will interfere with participation in this study
14 History of asthma present or past rule out complete history and examination of asthma and/or post bronchodilator FEV1 values greater than 400ml of predicted normal values with persistent airflow limitation or history of atopy or any other chronic respiratory disease other than COPD
15 Life threatening unstable respiratory disease including lower respiratory tract infection, within past 4 weeks from screening
16 History of lung resection of more than one full lobe
17 Scheduled for in patient hospitalization including elective surgery during the trial
18 History of clinically significant bladder neck obstruction or urinary retention
19 History of glaucoma
20 History of uncontrolled diabetes mellitus
21 Participation in clinical trial in within past 4 weeks of screening.
22 Female who is pregnant or lactating or planning to be pregnant.
23 Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator
24 Subjects on triple therapy on all combinations
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Mean change in trough FEV1
2 Mean change in trough FVC
3 Mean change in CAT scores
4 Proportion of subjects with a more than equal to 2 unit decrease in CAT
5 Proportion of subjects classified based on CAT severity as Low 0 to 10 medium 11 to 20 high 21 to 30 and very high 31 to 40
6 Mean change in R5 R5 minus R20 X5 Ax difference in X5 and Fres
7 Mean change in R5 R5 minus R20 and AX
8 Mean change in SGRQ C scores
9 Mean change in mMRC grades
10 Number of mild or moderate or severe exacerbations
11 Requirement of rescue medications and frequency
12 Adverse events treatment emergent adverse events and serious adverse events
 		 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
4 From baseline to 24 weeks
5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline
12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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)   30/09/2025 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
The study will include 260 biomass-exposed male and female COPD patients aged 35 years and above defined by GOLD 2023 criteria as symptoms + risk factors + post-bronchodilator FEV1 by FVC less than 0.70 and FEV1 less than  80 percent These participants will be enrolled from 10 centers across India and must be either treatment naïve or previously diagnosed COPD patients A 4-week washout or run-in period with plus 3 days if needed will be required for those previously on treatment

Baseline assessments will include spirometry chest X ray if done in last 6 months hemogram and where available oscillometry and FeNO Subjects will be grouped based on eosinophil counts those with 300 cells per mm3 or more n is130 and those with less than 300 cells per mm3 n is 130 In each group 65 will be randomly assigned to receive LABA and ICS and 65 to LABA and LAMA. Screening will account for a 20 percent dropout rate

After randomization participants will be followed up at weeks 4 12 and 24 with a 4 day flexibility window Asthalin will be used as rescue medication if needed During the run in or washout period subjects will receive Ipratropium and Levosalbutamol up to 4 times daily exceeding this will lead to withdrawal Medication will be stopped 24 hours before baseline recruitment and eosinophil testing Completion of the washout will be verified by the site investigator

 
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