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CTRI Number  CTRI/2026/02/104226 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 20/03/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Prospective Evaluation of Single-Nebulizer Triple Therapy in Patients With Uncontrolled Chronic Obstructive Pulmonary Disease Previously Treated With Single-Inhaler Triple Therapy 
Scientific Title of Study   A Prospective Study to evaluate the effectiveness and safety of Single Nebulizer Triple Therapy (NEB GFB) when switched from Single Inhaler Triple Therapy (SITT DPI/pMDI) In Uncontrolled COPD. 
Trial Acronym  SWITCH-NEB study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIS/2025/39 Version 1.0 Dated 12-Jan-2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Utpal Kumar Nandi 
Designation  Consultant Pulmonolgy 
Affiliation  Sparsh Hospital and Critical Care (P) Ltd 
Address  Annexure Building ground floor Research Department A/407,Saheed Nagar,Bhubaneswar

Khordha
ORISSA
751007
India 
Phone  7008744264  
Fax    
Email  drutpal_pul@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumit Bhushan 
Designation  Deputy General Manager, Clinical Studies Global Medical Affairs 
Affiliation  GLENMARK PHARMACEUTICALS LIMITED 
Address  GLENMARK PHARMACEUTICALS LIMITED Glenmark House, Corporate Building, Andheri(E), Mumbai

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  8800352225  
Fax    
Email  Sumit.Bhushan@glenmarkpharma.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashwini Kumar 
Designation  CEO  
Affiliation  CliniExperts Research Services Pvt Ltd  
Address  Unit No. 325, City Centre all, Plot No. 5, Sector 12, Dwarka, New Delhi

South West
DELHI
110075
India 
Phone  9999219448  
Fax    
Email  ashwini.kumar@cliniexpertsresearch.com   
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd. Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri (E), Mumbai – 400099 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd. 
Address  Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri (E), Mumbai – 400099 
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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santosh Jha  National Heart Institute  National Heart Institute Community Centre, 49-50, D Block, East of Kailash, New Delhi, Delhi 110065
South
DELHI 
7045251986

santosh.jha2712@gmail.com 
Dr Harsh Vij  Nivok Superspeciality Hospital  Delhi-Meerut Road,Modinagar,Sadabad Jakhaiva, Uttar Pradesh 201204
Ghaziabad
UTTAR PRADESH 
8308738920

harshv222@gmail.com 
Dr K Vikasna Reddy  Pranaam Hospitals Pvt Ltd  1-56/6/40 and 41,Pranaam Hospitals Ltd, Ramakrishna Nagar, Mythri Nagar, Miyapur, Madeenaguda, Hyderabad, Telangana 500050
Hyderabad
TELANGANA 
9397874735

vikasnareddy@gmail.com 
Dr Ajinkya Gulave  Rising Medicare Hospital  Survey No 4, 1, Mundhwa - Kharadi Rd, behind Radisson Blu, Pandhari Nagar, Kharadi, Pune, Maharashtra 411014
Pune
MAHARASHTRA 
8390308441

ajinkyagulave1990@gmail.com 
Dr Utpal Kumar Nandi  Sparsh Hospital and Critical Care (P) Ltd  Annexure Building ground floor Research Department A/407,Saheed Nagar,Bhubaneswar, Odisha,India 751007
Khordha
ORISSA 
7008744264

drutpal_pul@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
All India Heart Foundation (AIHF)- IEC  Approved 
Institutional Ethics Committee Pranaam Hospitals  Approved 
Institutional Ethics Committee Sparsh Hospital  Approved 
Rising Medicare Hospital & Institutional Ethics Committee  Approved 
Subharti Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J44||Other chronic obstructive pulmonary disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Neb GFB (Nebulized fixed-dose Glycopyrronium 25 µg + Formoterol 20 µg + Budesonide 500 µg)  Name of Product: Neb GFB (Nebulized fixed-dose Glycopyrronium 25 µg + Formoterol 20 µg + Budesonide 500 µg, administered via jet nebulizer BID) License Name: Nebzmart®-GFB Dosage Form: Smartule Dosage Frequency: Twice daily Duration: Till week 12 Mode of Administration: Inhalation Storage: Store in a refrigerator (2 - 8°C). Do not freeze 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged more than or equal to 40 years
Confirmed COPD diagnosis with post bronchodilator FEV1 by FVC less than 0.70
Symptomatic patients receiving ongoing treatment with SITT DPI or pMDI with mMRC score more than or equal to 2
Patients with post bronchodilator FEV1 between 30 to 80 percent predicted
Able to provide informed consent and comply with study procedures
Able and willing to use a nebulizer device
Able and willing to strictly adhere to investigators prescription 
 
ExclusionCriteria 
Details  • Severe COPD exacerbation requiring hospitalization, emergency room visit, or systemic
corticosteroids in the last 4 weeks before baseline
• Primary diagnosis of asthma, interstitial lung disease, pulmonary fibrosis, or
bronchiectasis
• Women of childbearing potential are not restricted in this study, however it is expected
that the investigator will assess the risks and benefits of the assigned treatment as per the
product label(s) and discuss this with any women of childbearing potential prior to
providing the patient with the prescription for the assigned treatment.
• Subjects with history of hypersensitivity to the active substance or to any of its excipients
of study drug.
• Any condition that, in investigator judgment, precludes safe participation or reliable data
capture. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of Neb GFB in symptomatic COPD patients switched from SITT DPI/pMDI  Mean change in mMRC dyspnea score from baseline and at week 12 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of Neb GFB in symptomatic COPD patients
switched from SITT DPI/pMDI 
Secondary endpoints (Effectiveness):
1) Mean change from baseline in 2 hrs post dose FEV1 on day 1
2) Mean change in Trough FEV1 and trough FVC from baseline and at weeks 1, 2, 4, 8, 12
3) Mean change in mMRC dyspnea score from baseline and at weeks 1, 2, 4, 8.
4) Proportion of patients achieving Clinically Meaningful Dyspnea Improvement ( more than or equal to 1 point reduction in mMRC score) from baseline to weeks 2, 4, 8, 12 (mMRC responders)
5) Proportion of patients experiencing exacerbations during the study period.
6) Proportion of patients requiring hospitalization during the study period
7) Rescue medication use averaged over week 12 of treatment
SABA (pMDI salbutamol) will be allowed to be used as a rescue medication throughout
the study
8) Proportion of patients requiring oral steroids and antibiotics [Time frame: 12 weeks]
9) Compliance with the study medication in terms of treatment adherence and persistence following the switch [Time frame: At week 12]
10) Assessment of patient’s satisfaction with the treatment [Time frame: 12 weeks]
11) Assessment of physician’s satisfaction with the treatment [Time frame: 12 weeks]

Secondary Endpoint (Safety):
1) Number of patients with any drug related treatment emergent adverse events (TEAEs).
[Time frame: up to 12 weeks]
2) Number of patients with TEAEs [Time Frame: up to 12 weeks]
3) Number of patients with serious TEAEs (STEAEs) [Time Frame: up to 12 weeks]

Exploratory Endpoints:
1) Proportion of patients achieving more than 100 ml improvement in FEV1 at week 1,2,4,8,12
 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   10/03/2026 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   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  

This multicentre, prospective, observational study is designed to assess the real-world effectiveness and safety of Single Nebulizer Triple Therapy (SNTT) in Indian patients with chronic obstructive pulmonary disease (COPD) who are switched from Single Inhaler Triple Therapy (SITT DPI/pMDI) based on the treating physician’s clinical judgement. Adult patients aged more than or equal to 40 years with a confirmed diagnosis of COPD, as defined by GOLD 2026 criteria, who require transition to SNTT in routine clinical practice will be enrolled after obtaining written informed consent. The total study duration will be 12 weeks.

At screening and baseline, a detailed medical history, physical examination, vital signs assessment, spirometry, and dyspnea evaluation using the modified Medical Research Council (mMRC) scale will be conducted. Patient and physician satisfaction questionnaires will also be completed. Enrolled subjects will receive nebulized fixed-dose Glycopyrronium (25 µg), Formoterol (20 µg), and Budesonide (500 µg) administered twice daily via a jet nebulizer. Participants will be provided with a subject diary to record adverse events, rescue medication use, and treatment compliance.

Patients will attend routine follow-up visits, preferably at weeks 1, 2, 4, 8, and 12. Safety will be monitored throughout the study. At each visit, spirometry, clinical examination, vital signs assessment, review of adverse events, concomitant medications, compliance, and subject diaries will be performed. The mMRC score, patient and physician satisfaction, and the frequency of exacerbations, hospitalizations, and rescue medication use will be assessed and documented.

 
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