Comparative Efficacy of Generic Salmeterol Xinafoate/Fluticasone Propionate MDI Fixed Dose Combination and Seretide ® MDI in Asthmatic Patients: An Open Label, Randomized, Phase III Study.

The addition of an inhaled long-acting β2-agonist (LABA) to an inhaled corticosteroid (ICS) gives optimal control of asthma in most patients. The long-acting β2-agonist (LABA) Salmeterol xinafoate (Salmeterol) and inhaled corticosteroid (ICS) fluticasone propionate (fluticasone) are being made available as a combination product Seretide® pMDI (Salmeterol/ Fluticasone) in a single aerosol inhaler. This randomized, open label, non-inferior, multicentric, 12-week, phase III study compared the efficacy and safety of generic Salmeterol/Fluticasone with commercially available product Seretide®. Materials and methods:Patients aged > 12 years inclusive of either sex (N = 372) with persistent asthma as defined by NHLBI for > 6 months prior to screening were included in the study. After a screening phase (1 week), eligible patients were enrolled in the trial with 2 weeks run in period. Eligible patients were randomized to receive either of the two treatment groups [HFA-Propelled pMDI Salmeterol/Fluticasone (25/250mcg) or HFA-Propelled Seretide® (25/250mcg) pMDI] in a ratio of 1:1 for the 12- week treatment period. The primary objective was to demonstrate non-inferiority of Salmeterol/Fluticasone versus Seretide®, measured by mean pre-dose forced expiratory volume in the first second (FEV1), at week 12. Results: This study provides evidence for the primary efficacy endpoint that Salmeterol/Fluticasone was statistically as well as clinically non-inferior to Seretide® in the treatment of patients with persistent asthma. This was supported by secondary endpoints which demonstrate that Salmeterol/Fluticasone appeared to be comparable to Seretide® in terms of efficacy for the secondary efficacy endpoints (morning PEFR, evening PEFR, diurnal variability of PEFR, daytime and night-time asthma symptoms score, average need for short acting-β2-agonists, proportion of patients that required rescue medication, patients with nocturnal asthma, patients without asthma symptoms of score 0 and average number of days without asthma symptoms of score 0). Salmeterol/Fluticasone was safe and well tolerated; and safety profile is comparable to comparator Seretide®. Conclusion: The results of study demonstrate that generic and innovator HFA formulations of Salmeterol/Fluticasone are clinically interchangeable. Overall, the study indicates that HFA-Propelled Salmeterol/ Fluticasone (25/250mcg) pMDI was safe, well tolerated and non-inferior in efficacy compared to HFA-Propelled Seretide® (25/250mcg) pMDI.

Effect of vitamin C administration on leukocyte vitamin C level and severity of bronchial asthma

Oxidative stress mediated by reactive oxygen species is known to contribute to the inflammatory process of bronchial asthma. Reactive oxygen species are released into the bronchial tree by activated inflammatory cells. In this study, we aimed to determine the effect of vitamin C administration on leukocyte vitamin C level as well as severity of asthma. In this double blind clinical trial study we evaluated 60 patients with chronic stable asthma. The patients were divided into two groups [A and B] including 30 patients in each group. Patients in these groups were matched according to their age, weight, height, gender, BMI and drug consumption. In addition to standard asthma treatment [according to stepwise therapy in 4[th] step of bronchial asthma] in which the patients were controlled appropriately, group A received 1000 mg vitamin C daily and group B received placebo. At the baseline and after one month treatment, non-fasting blood samples were drawn for laboratory evaluations. Asthmatic patient's clinical condition was evaluated through standard pulmonary function test [PFT]. The mean [ +/- SD] leukocyte vitamin C level in group A at the baseline and after one month treatment with 1000 mg/day vitamin C, were 0.0903 [ +/- 0.0787] microg/10[8] leukocytes and 0.1400 [ +/- 0.0953] microg/10[8] leukocytes respectively [P<0.05]. The mean [ +/- SD] leukocyte vitamin C level in group B at the baseline and after one month administration of placebo, were 0.0867 [ +/- 0.0629] microg/10[8] leukocytes and 0.0805[ +/- 0.0736] microg/10[8] leukocytes respectively. The leukocyte vitamin C level in group A was higher than those of group B after one month treatment with vitamin C and placebo and the difference was statistically significant [P<0.05]. Comparing PFT [FEV[1], FVC and FEV1/FVC] in group B during the study period showed a significant increase in FEV[1] [P<0.05], while the other two parameters remained unchanged. In group A, who received 1000 mg/day vitamin C, none of the spirometry parameters changed after one month treatment, indicating no effect of vitamin C treatment in the spirometry parameters

Niveles plasmáticos óptimos en estado de equilibrio y efecto broncodilatador de una teofilina de liberación controlada (TEOBID) / Best plasmatic levels in balance state and bronchodilator effect of a length liberation theophyline (TEOBID)

En el presente estudio se evalúa la efectividad de la dosis de 6.7 mg/kg/12 horas, de una formulación de teofilina de liberación controlada (Teobid), para conseguir niveles plasmáticos en estado de equilibrio, dentro el rango terapéutico (10 a 20 mcg/ml), correlacionando dichos niveles con su efecto broncodilatador en pacientes asmáticos de mediana severidad. Para lo cual se seleccionaron por conveniencia 24 pacientes, de ambos sexos, mayores de 9 y menos de 56 años de edad, de la Consulta de la Unidad de Asma del Servicio de Neumonología del Hospital "Dr. Luis Gómez López" de Barquisimeto. Los mismos fueron organizados en dos grupos, de 12 cada uno. Mediante un diseño ciego simple y previa determinación de sus valores basales espirométricos (CVF, VEF1, VEF1/CVF% y FEF 25-75%) los pacientes recibieron placebo o Teobid a la dosis antes señalada, durante 4 días, al final de los cuales fueron nuevamente evaluados en sus valores de teofilinemia y espirométricos. Los resultados demuestran que con las dosis administradas de Teobid se obtuvieron niveles de teofilinemia dentro del rango terapéutico en el 83.33% de los pacientes, los cuales evidenciaron mejoría significativa de sus valores espirométricos, fundamentalmente del FEF 25-75%, de la relación VEF1/CVF% y del VEF1