| 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
|
|
|
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
|
|
|
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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