Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: EXTRAFINE BECLOMETHASONE PLUS FORMOTEROL INHALER
: Extrafine Beclomethasone (100mcg) plus Formoterol (6mcg) per puff is administered through a metered dose inhaler with spacer. Treatme
STEP1 and 2 : One puff as needed, STEP 3: One puff twice daily, STEP 4: Two puffs twice daily. Duration is 12 weeks. The same inhaler is used as the reliever medication.
Control Intervention1: STANDAR
STEP 1 and 2 : One puff as needed, STEP 3: One puff twice daily, STEP 4 : Two puffs twice daily, Duration is 12 weeks. The same inhaler is used as the reliever medication.
Sponsors
T S SWETHA
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 to 65 years. Clinical diagnosis of asthma as per GINA 2025 guidelines with: a. History of variable respiratory symptoms such as wheeze, cough, chest tightness, or shortness of breath. b. Evidence of variable expiratory airflow limitation demonstrated by at least one of the following: Increase in FEV1 of 12 percent or more and 200 millilitres or more after bronchodilator administration. Peak expiratory flow variability of more than 10 percent. Other objective measures of variable expiratory airflow limitation as defined in the GINA 2025 guidelines. Ability and willingness to provide written informed consent. Willingness to comply with study procedures and follow up.
Exclusion criteria
Exclusion criteria: Age less than 18 years or more than 65 years. Patients unwilling or unable to provide written informed consent. Pregnant or lactating women. Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, or other chronic respiratory diseases apart from asthma, including post tubercular lung disease with fixed airflow limitation. Current pulmonary infection, including pneumonia, active tuberculosis, or fungal infections. Patients with other significant comorbid conditions that may interfere with interpretation of study results, such as advanced cardiac failure, active malignancy, severe hepatic disease, or severe renal disease. Known hypersensitivity or intolerance to any component of the inhaler formulations, including beclomethasone, budesonide, formoterol, or inhaler propellants. Inability to use a metered dose inhaler and spacer due to incoordination, cognitive dysfunction, or orofacial abnormalities. Patients currently using other types of inhaler devices and unwilling to switch to a metered dose inhaler.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Change in Asthma Control Questionnaire score from baseline to Week 12.Timepoint: Baseline and at 12 weeks after initiation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes Change in forced expiratory volume in one second and peak expiratory flow rate from baseline to Week 12. Change in Mini Asthma Quality of Life Questionnaire score from baseline to Week 12. Number of asthma exacerbations during the 12 week study period. Frequency of rescue inhaler use during the 12 week study period.Timepoint: At baseline and at 12 weeks after initiation of treatment. | — |
Countries
India
Contacts
Public ContactT S SWETHA
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHOPAL
Outcome results
None listed