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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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