VIAPAED (Vital Combination in Paediatric Asthma) Study

19 Apr, 14

Background

Asthmatic children, uncontrolled on standard doses of inhaled corticosteroids (ICS), guidelines recommend to either increase the ICS dose or to add further controller medication like a long-acting ?₂ agonists (LABA).

Objective of the Study

To compare the efficacy and safety of -

Doubling the dose of ICS (fluticasone propionate FP 200 mcg bid)
OR
Adding a long-acting beta₂ agonist to the ICS (SFC, salmeterol 50 mcg/FP 100 mcg bid)in children with uncontrolled asthma.

Study Method

No. of patients - 441
Children and adolescents aged 4-16 years.
Multicenter, randomized, double-blind, double-dummy, parallel-group study

Phases of the Study

Endpoints of the Study

Primary

Change in the mean morning expiratory peak flow (L/min) during week 8 of the treatment compared to baseline (week 0)

Secondary

Days without asthma symptoms & days without rescue salbutamol
PEFR from spirometry (before & after treatment)
Mean morning & evening PEFR

Results

Change in Morning PEF

SFC: Salmeterol/Fluticasone Combination
FP: Fluticasone Propionate

% Days Without Asthma Symptoms

8.2% more days without asthma symptoms with SFC than FP

% Days Without Rescue Salbutamol

7.5% more days without rescue salbutamol with SFC than FP

Morning & Evening PEF Readings

Morning & evening PEF increased at faster rate in SFC than FP.

SFC: Salmeterol/Fluticasone Combination FP: Fluticasone Propionate

Asthma Control

Good asthma control was achieved for a longer period in the SFC group

Discussion

Combination therapy with SFC, compared to treatment with FP b.i.d resulted in-

Better peak flow,
Less asthma symptoms,
Better asthma control,

Rapid and sustained improvements of symptoms and peak flow.
No. of adverse events and serious adverse events was similar and low in both treatment arms.

Conclusion

Larger benefit for pediatric patients with uncontrolled asthma.
Significant sustained improvement in morning peak flow after only two weeks of SFC.
Safe, tolerable and more effective than only ICS.
Confirmation of current pediatric guidelines.

Adding LABA to low-dose ICS is the preferred controller option for children older than 4 years with symptomatic asthma

Pediatric Pulmonology 2009; 44: 1132-42