Assessment of efficacy of triple therapy in uncontrolled asthma in Indian patients

Not Applicable

Not yet recruiting

Conditions: Other and unspecified asthma,

Registration Number: CTRI/2025/03/083179

Lead Sponsor: DR INDRANIL HALDER

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

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).

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): College of Medicine and JNM Hospital
🇮🇳
Nadia, WEST BENGAL, India
College of Medicine and JNM Hospital
🇮🇳Nadia, WEST BENGAL, India
DR INDRANIL HALDER
Principal investigator
9830304455
indranilh@yahoo.com