Health Condition 1: J454- Moderate persistent asthma
Conditions
Interventions
Intervention1: Budesonide/Formoterol pMDI: Medication: Budesonide 200 microgm + Formoterol 6 microgm per inhalation
Device: Pressurized metered-dose inhaler (pMDI)
Total Daily Dose: Budesonide 400
Sponsors
Indus International Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Asthma Diagnosis Confirmed moderate persistent asthma as per GINA guidelines Treatment Indication Prescribed inhaled corticosteroid or LABA combination for asthma control Device Competency Demonstrated ability to use both pMDI and DPI correctly during screening Stability: Clinically stable asthma therapy for at least 4 weeks Consent Written informed consent (parental consent for minors) Compliance Ability to attend regular follow-up visits Residence Local resident for follow-up feasibility Treatment Response Inadequate control on ICS monotherapy or established need for combination therapy Reversibility Demonstrated bronchodilator reversibility
Exclusion criteria
Exclusion criteria: Severe Asthma Requiring high-dose ICS/LABA combination or oral corticosteroids Mild Intermittent Asthma Not requiring regular controller therapy COPD Overlap: Significant smoking history (more than 10 pack-years) with fixed airflow obstruction Recent Exacerbation: Within 4 weeks of screening Other Respiratory Diseases: Active pneumonia, tuberculosis, or other significant lung disease Pregnancy/Lactation: For female patients of childbearing age Cardiovascular Contraindications Severe cardiac arrhythmias, recent myocardial infarction Beta-agonist Sensitivity Known hypersensitivity to formoterol or other LABA Cognitive Impairment Unable to understand or comply with study procedures Drug Allergy: Known hypersensitivity to budesonide, formoterol, or device components Participating Studies Current participation in other clinical trials Device Preference Strong preference for one device type that would affect compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effectiveness of budesonide/formoterol combination delivered via pMDI versus DPI on asthma control as measured by change in Asthma Control Test (ACT) scores from baseline to 12 weeks in patients with moderate persistent asthma.Timepoint: Screening day -14 to -1 baseline at Day 0 Week 2, 4,8 ,12 Follow up visit at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess differences in spirometry parameters between device groups 2.To compare rescue medication usage patterns between groups 3.To evaluate patient satisfaction and device preference scores 4.To assess inhaler technique competency development over time 5.To compare treatment adherence between pMDI and DPI groups 6.To evaluate device-related adverse events and tolerability 7.To assess quality of life changes between treatment groups 8.To analyze baseline factors predicting successful outcomes with each device 9.To evaluate the bronchodilator response with combination therapy 10.To assess time to onset of symptom improvement with each device Timepoint: Screening day -14 to -1 baseline at Day 0 Week 2, 4,8 ,12 Follow up visit at Week 16 | — |
Countries
India
Contacts
Public ContactMr Dharmender Singh Lather
Indus International Hospital
Outcome results
None listed