FindTrial
Sign In

Trial of Beclomethasone dipropionate versus Budesonide inhaler therapy in mild persistent asthma in children

To compare the clinical effects of beclomethasone dipropionate MDI with spacer and budesonide MDI with spacer in the treatment of children with mild persistent asthma aged 7 to 15 years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003495
Enrollment
85
Registered
2013-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Mild persistent asthma

Interventions

Intervention1: Beclomethasone dipropionate: Beclomethasone dipropionate 1 puff BD (dose- 200microgram /puff) using metered dose inhaler with spacer given for a total duration of two months daily Cont

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To compare the change in percentage predicted FEV1 after two months of intervention from baseline among the children receiving inhaled beclomethasone dipropionate( BDP) and budesonide(BUD). Timepoint: after two months of intervention from baseline—

Secondary

MeasureTime frame
1. To compare mean symptom scoring for day time and night time symptoms, limitation in daily activities, absence from school and need for rescue salbutamol inhaler. 2. To compare the number of exacerbations since last visit. 3. To compare the need for emergency visit or consultation with a paediatrician. 4. To compare the incidence of side effects. Timepoint: after two months of intervention from the baseline—

Countries

India

Contacts

Public ContactDr DevkiNandan

Dr. Ram Manohar Lohia Hospital

devkinandan2002@yahoo.com9868960811

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 1, 2026