Safety of extract EPs 7630 in young children with acute bronchitis.

Background: The efficacy and tolerability of DC. root extract EPs 7630 in children with acute bronchitis (AB) have been widely demonstrated. We investigated the safety and tolerability of a syrup formulation and an oral solution in pre-school children.

Effects of Pelargonium sidoides extract EPs 7630 on acute cough and quality of life - a meta-analysis of randomized, placebo-controlled trials.

Background: Cough is a leading symptom of viral acute respiratory infections such as acute bronchitis (AB) and the common cold (CC), which can be debilitating and may persist for several weeks. We investigated whether treatment with extract EPs 7630 may reduce cough and improve disease-related quality of life (QoL).

Methods: We performed a meta-analysis of randomized, placebo-controlled trials investigating the efficacy of EPs 7630 in AB or CC.

Liver Involvement in Acute Respiratory Infections in Children and Adolescents - Results of a Non-interventional Study.

Background: In children and adults with acute respiratory tract infections (ARTI), elevations of serum liver enzyme activities are frequently observed in clinical practice. However, epidemiological data particularly in the pediatric population are very limited. The aim of this study was to assess the incidence of hepatic involvement, to identify the viruses and to analyze risk factors in children and adolescents with ARTI in a real-world setting.

Faster recovery and reduced paracetamol use - a meta-analysis of EPs 7630 in children with acute respiratory tract infections.

Objective: Fever is a very common adaptive immune response in acute respiratory tract disorders during infancy. Antipyretic / analgesic drugs such as paracetamol (acetaminophen) are widely used to improve the comfort of the child but may cause medically unneeded antipyresis and rare but potentially serious side effects. We assess whether treatment with Pelargonium sidoides extract EPs 7630 reduces the administration of paracetamol in children with acute tonsillopharyngitis (ATP) or acute bronchitis (AB).

Validation of a Clinical Instrument for Measuring the Severity of Acute Bronchitis in Children - The BSS-ped.

Background: There are no validated standardised clinical procedures for severity measurement of acute bronchitis in children. The "BSS-ped", a short version of the physician-rated assessment scale BSS (Bronchitis Severity Scale), can fill this gap, if it is valid.

Objective: To examine the scale´s validity.

EPs 7630 is effective and safe in children under 6 years with acute respiratory tract infections: clinical studies revisited.

Objective: Pelargonium sidoides preparation EPs 7630 has been proven safe and effective in acute respiratory tract infections (aRTIs), but data for young children have not been presented separately. This study reviewed clinical studies and presents an overview of known and newly analyzed data from children <6 years.

Methods: MEDLINE and EMBASE were searched for interventional and non-interventional studies which investigated the effects of EPs 7630 in aRTIs and included children <6 years of age.

In Vitro Determination of Respimat Dose Delivery in Children: An Evaluation Based on Inhalation Flow Profiles and Mouth-Throat Models.

Background: Aerosol therapy in young children can be difficult. A realistic model based on handling studies and in vitro investigations can complement clinical deposition studies and be used to enable dose-to-the-lung (DTL) predictions.

Methods: Predictions on dose delivery to the lung were based on (1) representative inhalation flow profiles from children enrolled in a Respimat handling study, (2) in vitro measurement of the fine-particle DTL using mouth-throat models derived from nuclear magnetic resonance/computed tomography (NMR/CT) scans of children, and (3) a mathematical model to predict the tiotropium DTL.

A Handling Study to Assess Use of the Respimat(®) Soft Mist™ Inhaler in Children Under 5 Years Old.

Background: Respimat(®) Soft Mist(™) Inhaler (SMI) is a hand-held device that generates an aerosol with a high, fine-particle fraction, enabling efficient lung deposition. The study objective was to assess inhalation success among children using Respimat SMI, and the requirement for assistance by the parent/caregiver and/or a valved holding chamber (VHC).

Methods: This open-label study enrolled patients aged <5 years with respiratory disease and history of coughing and/or recurrent wheezing.

Inhalation solutions--which ones may be mixed? Physico-chemical compatibility of drug solutions in nebulizers--update 2013.

Many patients suffering from chronic respiratory diseases rely on inhalation therapy with nebulizers. About 25% of patients who need to inhale several different drugs per day save time by mixing them for simultaneous inhalation. This review presents a comprehensive overview of the available data concerning physico-chemical compatibility of commonly mixed nebulizer solutions and suspensions.

Physicochemical compatibility of nebulizable drug admixtures containing budesonide and colistimethate or hypertonic saline.

Knowledge of the physicochemical compatibility of admixtures of nebulizable drugs is an important issue. In this article, the results of our recent study dealing with the compatibility of drug admixtures containing budesonide and colistin methanesulfonate (brand name Colistin CF) or budesonide and 5.85% sodium chloride solution are presented, as well as the up-to-date version of our compatibility table.

Physicochemical compatibility and stability of nebulizable drug admixtures containing Dornase alfa and tobramycin.

The objective of this in-vitro study was to determine whether admixtures of the inhalation solutions Pulmozyme(®) (Dornase alfa) and either Bramitob(®) or Tobi(®) (both containing Tobramycin) are physicochemically compatible and to analyze the aerodynamic parameters of these admixtures. After mixing, test solutions were stored at room temperature and under ambient light conditions over a period of 24 h. Tobramycin concentrations were determined by using a fluorescence immunoassay.

Transient impact of omalizumab in pollen allergic patients undergoing specific immunotherapy.

Background: Recently, we showed that combination of omalizumab with specific immunotherapy (SIT) for treatment of patients with seasonal allergic rhinitis (SAR) and comorbid seasonal allergic asthma (SAA) is safe and reduced the symptom load in a statistically significant and clinically meaningful manner during the first pollen season.

Objective: The aim of this study was to investigate long-lasting effects of an initial combination treatment with SIT+omalizumab, a monoclonal anti-IgE antibody, in a follow-up period with SIT treatment only in patients with SAR and comorbid SAA incompletely controlled by conventional pharmacotherapy.

Methods: A randomized, double-blind, placebo-controlled, multicenter trial was performed to assess the efficacy and safety of omalizumab (Xolair(®)) vs.

An open-label, randomized efficacy and safety trial of subcutaneous and intramuscular BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of HBV-carrier mothers.

Objective: The objective of the study was to assess the efficacy and safety of subcutaneously (SC) and intramuscularly (IM) administered BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of hepatitis B surface antigen (HBs/HBsAg)-positive mothers in the prevention of hepatitis B infection.

Methods: This was an open, prospective, multicenter trial, in which infants were randomized to receive a single SC or IM dose of BT088 (200 IU, 0.4 mL) within 12 h of birth simultaneously with active vaccination against hepatitis B.

Clinical characteristics of adults with slowly progressing mucopolysaccharidosis VI: a case series.

Objective: To assess clinical features and general health status of adult patients with mucopolysaccharidosis (MPS) VI.

Methods: This report includes the clinical history of patients older than 18 years with slowly progressing MPS VI and the retrospective analysis of the outcomes of available data collected between September 2003 and October 2008 at the Center of Pediatric and Adolescent Medicine, University Medical Center, Johannes Gutenberg-University of Mainz, Germany. Variables included were urinary glycosaminoglycan (uGAG) level, mutation analysis, body height, forced vital capacity (FVC), 6-minute walk test, echocardiographic findings, the need for craniocervical decompression surgery, orthopaedic findings and ophthalmological assessments.

Treatment of acute bronchitis with EPs 7630: randomized, controlled trial in children and adolescents.

Background: The aim of this trial was to investigate the efficacy and tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides, in children and adolescents suffering from acute bronchitis, outside the strict indication for antibiotics.

Methods: A total of 220 patients with acute bronchitis were randomized and given either verum containing EPs 7630 (1-6 years/>6-12 years/>12-18 years: 3 × 10/3 × 20/3 × 30 drops/day) or matching placebo for 7 days. The main outcome measure was the change in the total score of bronchitis-specific symptoms (BSS) from day 0 to day 7.

Mucopolysaccharidosis type II: European recommendations for the diagnosis and multidisciplinary management of a rare disease.

Unlabelled: Mucopolysaccharidosis type II (MPS II) is a rare, life-limiting, X-linked recessive disease characterised by deficiency of the lysosomal enzyme iduronate-2-sulfatase. Consequent accumulation of glycosaminoglycans leads to pathological changes in multiple body systems. Age at onset, signs and symptoms, and disease progression are heterogeneous, and patients may present with many different manifestations to a wide range of specialists.

Add-on salmeterol compared to double dose fluticasone in pediatric asthma: a double-blind, randomized trial (VIAPAED).

Rationale: In asthmatic children whose symptoms are uncontrolled on standard doses of inhaled corticosteroids (ICS), guidelines recommend to either increase the ICS dose or to add further controller medication, e.g. a long acting ss2-agonist (LABA).

Safety of anti-IgE treatment with omalizumab in children with seasonal allergic rhinitis undergoing specific immunotherapy simultaneously.

Introduction: Seasonal allergic rhinitis (SAR) affects at least 10-25% of the Caucasian race and about 40% of patients are children. Standard treatment of SAR is specific immunotherapy (SIT), but anti-allergic drugs can significantly enhance efficacy of SIT. One candidate is the humanized monoclonal anti-IgE antibody omalizumab.

A novel approach to CFTR mutation testing by pyrosequencing-based assay panels adapted to ethnicities.

Background: Cystic fibrosis (CF) is a common autosomal recessive genetic disorder caused by a variety of sequence alterations in the CFTR gene [cystic fibrosis transmembrane conductance regulator (ATP-binding cassette sub-family C, member 7)]. Because the relative prevalence of mutations strongly depends on the ethnic background, first-level testing of CF as defined by recent consensus recommendations ought to be adaptable to the ethnicity of patients.

Methods: We therefore developed and implemented a diagnostic approach to first-level testing for CF based on published mutation frequencies and Pyrosequencing (PSQ) technology that we complemented with standard procedures of mutation detection at the second level.

Physicochemical compatibility of mixtures of dornase alfa and tobramycin containing nebulizer solutions.

Patients suffering from cystic fibrosis (CF) often need to inhale multiple doses of different nebulizable drugs per day. Patients attempt to shorten the time consuming administration procedure by mixing drug solutions/suspensions for simultaneous inhalation. The objective of this experimental study was to determine whether mixtures of the nebulizer solution dornase alfa (Pulmozyme) with tobramycin nebulizer solutions (TOBI and GERNEBCIN 80 mg) are physico-chemically compatible.

Diagnosis and management of respiratory involvement in Hunter syndrome.

Unlabelled: Respiratory problems are frequently encountered by patients with Hunter syndrome and contribute to the premature mortality seen in individuals with the disease. Progressive deposition of glycosaminoglycans in the soft tissue of the throat and trachea is thought to be responsible for the airway dysfunction and obstruction, which characterize the syndrome. Other physical characteristics, including abnormalities in the shape and structure of the ribs, abdominal organ enlargement, short neck and immobile jaw, further contribute to the respiratory problems.

How pre- and postnatal risk factors modify the effect of rapid weight gain in infancy and early childhood on subsequent fat mass development: results from the Multicenter Allergy Study 90.

Background: It is unclear which exposures may cause or modify the adverse effect of rapid weight gain on fat mass development in term children whose birth weight is appropriate-for-gestational age (AGA).

Objective: To determine which intrauterine or postnatal exposures increase the risk of or modify the effect of rapid weight gain on body fat percentage (BF%) and body mass index (BMI) trajectories between 2 and 6 y of age.

Design: Term AGA singletons (n = 370) from the German Multicenter Allergy Study (MAS-90), a longitudinal birth cohort study, with repeated anthropometric measurements until 6 y, and data on breastfeeding status, exposure to smoking during pregnancy, and maternal anthropometric and socioeconomic characteristics were included in this analysis.

Physicochemical compatibility of fluticasone-17- propionate nebulizer suspension with ipratropium and albuterol nebulizer solutions.

The objective of this in-vitro study was to determine whether mixtures of three nebulizable drugs are physicochemically compatible. Drug combinations were prepared by mixing the content of one respule Flutide forte "ready to use" (fluticasone propionate) with 2 milliliter Atrovent LS (ipratropium bromide) and 0.5 milliliter Sultanol inhalation solution (albuterol sulfate).