Presentation: Rupatadine oral solution is efficacious and safe in children ( aged 6-11 years) with persistent allergic rhinitis (World Allergy Congress)

Wednesday, 7 December 2011

Poster Hall (Cancún Center)

Paul Potter, MD, FCP(SA), FAAAAI, FACACI , Allergy Diagnostic & Clinical Research Unit, University of Cape Town Lung Institute, Mowbray, South Africa

Jorge Maspero, MD , Allergy and Respiratory Research Unit, Fundacion CIDEA, Buenos Aires, Argentina

Jesús María Garde, MD , Hospital General Universitario de Elche, Alicante, South Africa

Hugo E. Neffen , Centro de Alergia e Inmunología, Santa Fé, Argentina

Jan Vermeulen, MD , Private consult, CApe Town, South Africa

László Barkai, MD , BAZ Megyei Kórház Gyermekegészségügyi Központ, Miskolc, Hungary

Ildikó Nemeth, MD , Szent Erzsébet Kórház , Jászberény, Hungary

Iris Medina, MD , Centro Médico Vitae, Buenos Aires, Argentina

Alejandro Domenech, phD , Clinical Development Unit, Uriach Pharma, Barcelona, Spain

Josep Giralt , Clinical Development Unit, Uriach Pharma, Barcelona, Spain

Santiago Zas , Project Leader , Nuvisan , MAdrid, Spain

Iñaki Izquierdo, MD, PhD , Clinical Development Unit, Uriach Pharma, Barcelona, Spain

Background: Clinical trials with the newer non-sedating antihistamines in children under the age of 12 years have been performed in the previous years but further studies are needed in order to show efficacy and safety in the most unfavourable clinical conditions such as persistent allergic rhinitis (PER). Rupatadine is a promising treatment for children with allergic rhinitis in view of its rapid onset of action and its lack of relevant side effects at higher than therapeutic doses.

Objective: To assess the efficacy and safety of rupatadine (RUP) oral solution in children between 6 and 11 years with PER.

Methods: A randomized, double-blind, multicenter and placebo-controlled study was carried out in 34 centres in Argentina, South Africa, Hungary and Spain. Main selection criteria included patients between 6-11 years diagnosed as PER according to ARIA criteria, with a positive prick test, weight ≥ 16 kg and a basal nasal symptoms score (rhinorrhea, nasal blockage, sneezing and nasal itching assessment) ≥ 24 obtained in 4 days prior 2-weeks. Patients were allocated to RUP oral solution (1 mg/ml) or placebo during 6 weeks. The dose was adjusted by body weight. The efficacy endpoint was the change from baseline of the nasal and global symptoms score at 4 and 6 weeks of treatment.Results: A total of 445 patients were screened, of which 360 were finally included. Table 1 summarizes the efficacy results:

Parameter

Placebo (n=180)

Rupatadine (n= 180)

P-value

4TSS baseline

7.2 (1.1)

7.2 (1.1)

ns

Change 4TSS vs baseline at 4 weeks

-2.5 (1.9)

-3.1 (2.1)

P= 0.018

% of reduction at 4 weeks

34.7%

43.1%

Change 4TSS vs baseline at 6 weeks

-2.7( 1.9)

-3.3 (2.1)

P= 0.048

% of reduction at 6 weeks

37.5%

45.8%

Adverse events were scarce in both treatment groups throughout the study. ECGs (QTc) and lab tests did not show any relevant finding.

Conclusions: Rupatadine oral solution was significantly more effective than placebo in reducing nasal symptoms at 4 and 6 weeks. Rupatadine was well tolerated, without differences in somnolence between both groups. This is the first clinical evidence of a H₁-receptor antagonist efficacy in children with PER.

Parameter	Placebo (n=180)	Rupatadine (n= 180)	P-value
4TSS baseline	7.2 (1.1)	7.2 (1.1)	ns
Change 4TSS vs baseline at 4 weeks	-2.5 (1.9)	-3.1 (2.1)	P= 0.018
% of reduction at 4 weeks	34.7%	43.1%
Change 4TSS vs baseline at 6 weeks	-2.7( 1.9)	-3.3 (2.1)	P= 0.048
% of reduction at 6 weeks	37.5%	45.8%

4034 Rupatadine oral solution is efficacious and safe in children ( aged 6-11 years) with persistent allergic rhinitis