| CTRI Number |
CTRI/2025/02/080369 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of Triple versus Dual Therapy in COPD Using Surfactant Protein-D as a Biomarker
|
|
Scientific Title of Study
|
Comparing the Efficacy of Triple Therapy and Dual Therapy in COPD Patients using Surfactant Protein-D as a Biomarker : 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 |
Anusha |
| Designation |
Research Scholar |
| Affiliation |
SRM college of Pharmacy, SRMIST |
| Address |
Department of Pharmacy Practice
4th Floor
SRM Medical college Hospital and Research center
SRMIST
Kattankaluthur
Chennai
TAMIL NADU
603203
India |
| Phone |
7200588314 |
| Fax |
|
| Email |
anushas26071996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nalini Jayanthi |
| Designation |
Head and Professor |
| Affiliation |
SRM college of Pharmacy SRMIST |
| Address |
Department of Respiratory Medicine
1st Floor
SRM Medical College Hospital
SRM IST
Chennai
TAMIL NADU
603203
India |
| Phone |
9444226783 |
| Fax |
|
| Email |
nalinijayanthi59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T M Vijayakumar |
| Designation |
Professor and Head |
| Affiliation |
SRM college of Pharmacy SRMIST |
| Address |
Department of Pharmacy Practice
4th Floor
SRM Medical college Hospital and Research center
SRMIST
Kattankaluthur
Chennai
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijayakm2@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital And Research Centre
SRM Nagar
Potheri
Chengalpattu
Tamil Nadu 603203 |
|
|
Primary Sponsor
|
| Name |
SRMIST |
| Address |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SRMIST
KATTANKULATHUR
CHENGALPATTU
TAMIL NADU 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nalini Jayanthi |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Department of Respiratory Medicine 1st Floor SRM Medical College Hospital SRM IST
Chennai
Chennai
TAMIL NADU |
9444226783
nalinijayanthi59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee SRM Medical college Hopsital and Research Institute |
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 |
Budesonide
Glycopyrrolate
Formoterol |
Dose and Composition: Budesonide 160 mcg Glycopyrrolate 9 mcg Formoterol 4.8 mcg.
Mode of Administration: Administered via a single metered-dose inhaler.
Frequency and Duration: Inhaled twice daily for 24 weeks. |
| Comparator Agent |
Glycopyrrolate
Formoterol |
Dose and Composition: Glycopyrrolate 9 mcg Formoterol 4.8 mcg.
Mode of Administration: Administered via a single metered-dose inhaler.
Frequency and Duration: Inhaled twice daily for 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Post bronchodilator FEV1/FVC ration less than 0.70
History of at least 1 moderate or severe exacerbation in the past 12 months
Eosinophil count more than 100 cells per microliter
CAT score more than 10 or mMRC dyspnea score more than or equal to 2
|
|
| ExclusionCriteria |
| Details |
Diagnosis of asthma or other significant respiratory diseases (e.g., pulmonary fibrosis, lung cancer).
History of severe cardiovascular diseases (e.g., myocardial infarction, unstable angina, heart failure).
Patients with severe cognitive or psychiatric disorders that may impair study participation.
History of hypersensitivity to any of the study medications.
Active infections requiring antibiotics or systemic steroids at the time of enrollment.
Women who are pregnant, and breastfeeding.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess changes in forced expiratory volume in 1 second (FEV1) from baseline, and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation.
|
To assess changes in forced expiratory volume in 1 second (FEV1) from baseline,12 and 24 weeks and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the impact of BGF triple therapy compared to dual therapy on symptom relief, using the COPD Assessment Test (CAT) & Modified Medical Research Council (mMRC) Dyspnea Scale.
To evaluate changes in quality of life (QoL) between treatment groups, measured by the St. George’s Respiratory Questionnaire (SGRQ).
To evaluate the effect of BGF triple therapy versus dual therapy on exacerbation frequency, defined as moderate or severe exacerbations requiring treatment or hospitalization.
To investigate changes in Surfactant Protein D (SP-D) levels in response to treatment & their association with clinical outcomes such as lung function, symptoms, & exacerbation rates.
|
baseline
12 weeks
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
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 4 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="2"
Months="0"
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
|
Despite the widespread use of these therapies, there is ongoing debate about the timing and benefits of transitioning patients from dual to triple therapy, particularly as their disease progresses from mild to more severe stages. This study seeks to address this gap by randomizing patients who are transitioning from mild to moderate or severe COPD into two treatment groups: those receiving dual therapy and those receiving triple therapy. Through this randomized controlled trial, we aim to evaluate and compare the efficacy of these therapeutic approaches in preventing exacerbations, improving lung function, and enhancing quality of life, while also exploring Surfactant Protein-D (SP-D) as a biomarker of disease activity and treatment response. This study holds particular significance in countries like India, where COPD presents a growing public health challenge. |