Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
College of Medicine and JNM Hospital, Kalyani