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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083179
Enrollment
100
Registered
2025-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J459- Other and unspecified asthma

Interventions

Intervention1: 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 +Glyc

Sponsors

DR INDRANIL HALDER
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To assess improvement in control level of asthma by calculating change in ACQ-5 score from baseline to 12th week.Timepoint: 12 weeks after intervention.

Secondary

MeasureTime frame
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 Timepoint: 12 weeks after intervention.

Countries

India

Contacts

Public ContactDR INDRANIL HALDER

College of Medicine and JNM Hospital, Kalyani

indranilh@yahoo.com9830304455

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026