Trial of Beclomethasone dipropionate versus Budesonide inhaler therapy in mild persistent asthma in childre
- Conditions
- Health Condition 1: null- Mild persistent asthma
- Registration Number
- CTRI/2013/03/003495
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 85
patients of newly diagnosed mild persistent asthma (as per GINA GUIDELINES) aged 7 to 15 years were enrolled.Also these patients should show improvement of more than equal to 12% in fev1 after 15 minutes of administration of four separate doses of 100 microgram of salbutamol mdi with spacer. Written informed consent was obtained
The following patients were excluded: Patients who have received oral, parenteral or inhaled steroids during last one month; patients with any underlying chronic illness including cystic fibrosis, pneumothorax, chronic suppurative lung disease, tuberculosis, congenital heart diseases and any other chronic systemic illness; Patients unable to use inhaler with spacer or perform spirometry; patients with lower respiratory tract infections in the last one month; and refusal of consent. Written informed consent was obtained from parents of all subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change in percentage predicted FEV1 after two months of intervention from <br/ ><br>baseline among the children receiving inhaled beclomethasone dipropionate( BDP) and budesonide(BUD). <br/ ><br>Timepoint: after two months of intervention from baseline <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.To compare mean symptom scoring for day time and night time symptoms, limitation <br/ ><br>in daily activities, absence from school and need for rescue salbutamol inhaler. <br/ ><br>2.To compare the number of exacerbations since last visit. <br/ ><br> <br/ ><br>3.To compare the need for emergency visit or consultation with a paediatrician. <br/ ><br> <br/ ><br>4. To compare the incidence of side effects. <br/ ><br>Timepoint: after two months of intervention from the baseline