CTRI Number |
CTRI/2025/03/083179 [Registered on: 24/03/2025] Trial Registered Prospectively |
Last Modified On: |
21/03/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Single Arm Study |
Public Title of Study
|
Assessment of efficacy of triple therapy in uncontrolled asthma in Indian patients |
Scientific Title of Study
|
Assessment of efficacy of triple therapy in uncontrolled asthma in Indian patients |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR INDRANIL HALDER |
Designation |
Associate Professor and Head of the Department |
Affiliation |
College of Medicine and JNM Hospital, Kalyani |
Address |
JNM Hospital, Block A2, Kalyani,
HOD Room
Department of Respiratory Medicine
Nadia WEST BENGAL 741235 India |
Phone |
9830304455 |
Fax |
|
Email |
indranilh@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
DR INDRANIL HALDER |
Designation |
Associate Professor and Head of the Department |
Affiliation |
College of Medicine and JNM Hospital, Kalyani |
Address |
JNM Hospital, Block A2, Kalyani,
HOD Room
Department of Respiratory Medicine
Nadia WEST BENGAL 741235 India |
Phone |
9830304455 |
Fax |
|
Email |
indranilh@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
DR INDRANIL HALDER |
Designation |
Associate Professor and Head of the Department |
Affiliation |
College of Medicine and JNM Hospital, Kalyani |
Address |
JNM Hospital, Block A2, Kalyani,
HOD Room
Department of Respiratory Medicine
Nadia WEST BENGAL 741235 India |
Phone |
9830304455 |
Fax |
|
Email |
indranilh@yahoo.com |
|
Source of Monetary or Material Support
|
CIPLA LTD
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013. |
|
Primary Sponsor
|
Name |
DR INDRANIL HALDER |
Address |
JNM Hospital, Block A2,, Kalyani, West Bengal 741235 |
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 INDRANIL HALDER |
College of Medicine and JNM Hospital |
JNM Hospital, Block A2, Kalyani,
HOD Room
Department of Respiratory Medicine
741235 Nadia WEST BENGAL |
9830304455
indranilh@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, College of Medicine and JNM hospital, WBUHS, Kalyani Nadia |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Inhaled Triple Therapy (ICS + LABA + LAMA) |
Patients not controlled on dual inhaled therapy (ICS+LABA), will be initiated on above mentioned intervention(inhaled Budesonide 200mcg +Glycopyrronium 12.5 mcg +Formoterol 6 mcg pMDI) 2 puffs twice a day through spacer |
Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1)Previously diagnosed asthma as per GINA guideline
2)Patients who are on dual therapy (ICS+LABA)
3)Patients who are uncontrolled on therapy (Low ACQ5 score)
|
|
ExclusionCriteria |
Details |
1.Patients with known COPD, heart disease, kidney disease.
2.Patients who are on triple therapy with tiotropium.
3.Patients who are well controlled on dual therapy.
4.Haemodynamically unstable patients.
5.Patients not willing to give consent.
6.Patients aged less than 18 years.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To assess improvement in control level of asthma by calculating change in ACQ-5 score from baseline to 12th week. |
12 weeks after intervention. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Change in trough FEV1 from baseline to week 12. Trough FEV1 is defined as the measurement of FEV1 levels after conducting routine test (laboratory investigations, ECG, vitals) and immediately prior to inhalation of first dose of the day.
2.Improvement in FEV1, FVC & FEF25-75 at 12 weeks
3.Total daily symptom score, percentage of days with no symptoms, percentage of nights with no night time awakenings
4.Reduction in the number of puffs of rescue medication use and percentage of days without rescue medication use.
5.Minimal clinically important difference (MCID) increase in ACQ5 at the end of 12 weeks.
6.Change in rate of asthma exacerbations
|
12 weeks after intervention. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
07/04/2025 |
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="0" 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 - NO
|
Brief Summary
|
Asthma is a chronic respiratory disease marked by persistent airway inflammation, hyperresponsiveness, and variable airflow limitation. Despite advancements in therapy, achieving optimal control remains challenging for many patients. Uncontrolled asthma, characterized by poor symptom control and frequent exacerbations, persists in patients receiving dual therapy with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). Long-acting muscarinic antagonists (LAMAs), such as tiotropium, have been incorporated into asthma management as an add-on therapy for patients with persistent symptoms. Tiotropium has demonstrated efficacy in improving lung function, reducing exacerbations, and enhancing symptom control. However, glycopyrronium, another LAMA, has not been extensively studied in the context of asthma, despite its favorable pharmacokinetics and efficacy in chronic obstructive pulmonary disease (COPD). This study aims to bridge the gap in evidence by evaluating the efficacy of triple therapy comprising formoterol (LABA), budesonide (ICS), and glycopyrronium (LAMA) in Indian patients with uncontrolled asthma. By leveraging the unique pharmacological properties of glycopyrronium, we hypothesize that this combination will significantly improve asthma control as measured by the Asthma Control Questionnaire (ACQ-5) score. This investigation is crucial in addressing the unmet needs of asthma patients in the Indian context, where environmental and genetic factors may influence treatment outcomes.
We plan to assess whether triple therapy is beneficial in achieving asthma control in patients who have uncontrolled disease on ICS/LABA dual therapy. |