Eficácia e segurança de dois inaladores de pó seco usados para a aplicação de furoato de mometasona em pacientes com asma / Efficacy and safety of two dry-powder inhalers for the administration of mometasone furoate in asthma patients

OBJETIVO: O furoato de mometasona (FM) é um novo corticosteroide inalatório sintético potente. Internacionalmente, o FM é fornecido em um inalador de pó seco que permite sua administração em múltiplas doses. Para se obter uma preparação com melhor relação custo-eficácia, foram desenvolvidas no Brasil formulações de FM em cápsulas de pó seco para serem administradas em dose única. O presente estudo teve como objetivo avaliar a eficácia e a segurança dos dois inaladores usados para a administração de FM em pacientes asmáticos. MÉTODOS: Estudo clínico, aberto, comparativo, paralelo e multicêntrico com 74 adultos portadores de asma persistente e moderada, randomizados em dois grupos para receber FM em uma dose de aproximadamente 400 µg, fornecida por um inalador de dose múltipla ou pelo novo inalador de dose única, uma vez ao dia durante 60 dias. RESULTADOS: Não foram observadas diferenças significantes entre os dois grupos estudados nos desfechos primários (VEF1 e frequência do uso de medicação de resgate) ou nos desfechos secundários (PFE matinal, tolerabilidade e segurança, essa última avaliada pelo estudo do eixo hipotálamo-hipófise-adrenal). CONCLUSÕES: A administração de FM com o novo inalador de dose única desenvolvido no Brasil tem eficácia e segurança comparáveis à administração com o inalador de dose múltipla no tratamento de pacientes asmáticos.

OBJECTIVE: Mometasone furoate (MF) is a new, potent synthetic inhaled corticosteroid. Worldwide, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more cost-effective, single-dose MF capsules were developed in Brazil. The objective of the present study was to evaluate the efficacy and safety of the two inhalers for MF administration in patients with asthma. METHODS: A randomized, multicenter, open-label, parallel-group clinical trial involving 74 adult patients with moderate, persistent asthma who were randomized into two groups to receive approximately 400 µg of MF once a day for 60 days, either via the multiple-dose inhaler or via the newly developed single-dose inhaler. RESULTS: No significant differences were observed between the two groups regarding the primary endpoints (FEV1 and rescue medication use) or the secondary endpoints (morning PEF, tolerability, and safety, the last as assessed on the basis of hypothalamic-pituitary-adrenal axis function). CONCLUSIONS: The use of the single-dose inhaler developed in Brazil for MF administration is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma.

Efficacy, safety and tolerability of mometasone furoate 0.1% cream, ointment and lotion in childhood eczema

Topical corticosteroids have been the first line treatment in children with eczema. Efforts to develop new topical glucocorticoids with reduce systemic bioactivity help to treat them. Mometasone furoate 0.1% has been found to be efficacious in children with atopic dermatitis. To evaluate the therapeutic efficacy, safety and tolerability of mometasone furoate 0.1% cream, ointment and lotion in childhood eczema. The study was conducted from Oct 2007 to Jan 2008 at the outpatient department of dermatology at Abbasi Shaheed Hospital, Karachi. A total of 50 children, aged >12 years, of either sex with all types of childhood eczema were included in the study and those with infection, complication like scars, atrophy, striae, etc, known hypersensitivity to corticosteroids and on any other medicaments were excluded. Parents of children were instructed to apply a thin layer with gentle rubbing twice daily for three weeks. Fingertip unit [FTU] was demonstrated to parents. Tubes of mometasone furoate 0.1% cream, ointment and lotion were given to parents according to the need. Emollient was applied twice daily. Children were followed up at 3, 6 and 12 weeks. SPSS - 13.0 was used for statistical analysis. Friedman test was applied to compare the significance of results at p<0.05. Out of 50 patients enrolled, at 3 weeks of follow-up only 43 reported. 29 [67% showed improvement and 14 [32%] fully resolved. At 6 weeks 32 [74.4%] had complete resolution and 7 [16.2%] had improved, but at 12 weeks only 25 patients [58%] had resolved and 6 patients [13.9%] relapsed, while 2 patients were gradually improving. Efficacy in resolution of sign/symptoms on 12 weeks was [p<0.001]. No cutaneous or systemic side effects were seen. Mometasone furoate 0.1% cream, ointment and lotion are found to be effective, safe and highly tolerable in childhood eczema and the compound was found equally safe in infants

Comparative potency of formulations of mometasone furoate in terms of inhibition of 'PIRHR' in the forearm skin of normal human subjects measured with laser doppler velocimetry.

BACKGROUND AND AIMS: Topical glucocorticoid formulations are widely used for effective treatment and control of a variety of dermatoses. Mometasone furoate is a newer corticoid that has high potency but low systemic toxicity. Pharmaceutical factors are known to significantly influence potency and systemic absorption of topically applied glucocorticoids. We studied the potency of "Elocon", a topical formulation of mometasone furoate, compared with two other branded formulations of the same corticoid. METHODS: Corticoid potency was measured by employing a pharmacodynamic parameter of an inhibitory effect of the corticoid on post-ischemic-reactive-hyperemic-response (PIRHR) in human forearm skin under occlusive dressing. The PIRHR was expressed in terms of % increase in the skin blood flow (SBF) as measured with laser doppler velocimetry (LDV). RESULTS : All three active branded formulations of mometasone furoate produced significant inhibition of PIRHR. The AUC(0-2 min) of PIRHR was ( Mean +/- SEM ), Control = 213.52 +/- 11.80, Placebo = 209.77 +/- 19.31, Formulation A = 119.83 +/- 13.71, Formulation C = 53.67 +/- 4.85 and Formulation D = 111.46 +/- 22.87. Formulation "C" exhibited significantly higher topical anti-inflammatory potency than formulations "A" or "D". CONCLUSIONS: Thus, branded formulations of the same glucocorticoid, mometasone furoate significantly differed in their topical anti-inflammatory potency. "Elocon" was significantly more potent than the two other branded formulations studied.

Therapeutic efficacy and safety of loratadine syrup in childhood atopic dermatitis treated with mometasone furoate 0.1 per cent cream.

Atopic dermatitis is a common skin disease in Thai children. The treatment of atopic dermatitis requires topical corticosteroids, emollients, systemic antihistamine as well as avoidance of the precipitating factors. A double blind multicenter placebo controlled study was conducted to assess the therapeutic efficacy of topical mometasone furoate 0.1 per cent cream in combination with loratadine syrup. Forty-eight patients, 23 boys and 25 girls, mean age 73.67 months, with atopic dermatitis were included in the study. The severity of the disease was measured by using the SCORAD index including the degree of erythema, dryness, edema/papulation, oozing/crusting, lichenification, and excoriation. Total area involved was measured and a target area of dermatitis was selected for specific evaluation. The degree of clinical signs and pruritic symptom was graded. The sensation of pruritus, disturbance of sleep due to pruritus, and feeling of sleepiness in the morning were recorded. Mometasone furoate 0.1 per cent cream was applied to all patients once daily. One group received loratadine syrup and another group received placebo syrup. They were followed-up on day 5, 8 and 15. The severity of atopic dermatitis and pruritus significantly decreased after 14 days of treatment in both groups (p < 0.001). There was no difference in therapeutic response between the loratadine and placebo groups (p = 0.99). All signs examined had decreased by the end of the study. The result demonstrated that 0.1 per cent mometasone therapy is very effective for treating childhood atopic dermatitis. Loratadine did not show beneficial effect when combined with good topical corticosteroid but it was safe and had no serious side effect on the children.