Tolerability of inhaled N-chlorotaurine in humans: a double-blind randomized phase I clinical study.

Background: N-chlorotaurine (NCT), a long-lived oxidant produced by human leukocytes, can be synthesized chemically and used topically as a well-tolerated antiseptic to different body regions including sensitive ones. The aim of this study was to test the tolerability of inhaled 1% NCT in aqueous solution upon repeated application.

Methods: The study was performed double-blind and randomized with a parallel test group (1% NCT) and control group (0.

The safety and pharmacokinetics of rapid iloprost aerosol delivery via the BREELIB nebulizer in pulmonary arterial hypertension.

The BREELIB nebulizer was developed for iloprost to reduce inhalation times for patients with pulmonary arterial hypertension (PAH). This multicenter, randomized, unblinded, four-part study compared inhalation time, pharmacokinetics, and acute tolerability of iloprost 5 µg at mouthpiece delivered via BREELIB versus the standard I-Neb nebulizer in 27 patients with PAH. The primary safety outcome was the proportion of patients with a maximum increase in heart rate (HR) ≥ 25% and/or a maximum decrease in systolic blood pressure ≥ 20% within 30 min after inhalation.

Small airway deposition of dornase alfa during exacerbations in cystic fibrosis; a randomized controlled clinical trial.

Introduction: Small airway obstruction is important in the pathophysiology of cystic fibrosis (CF) lung disease. Additionally, many CF patients lose lung function in the long term as a result of respiratory tract exacerbations (RTEs). No trials have been performed to optimize mucolytic therapy during a RTE.

What puts the adverse in 'adverse events'? Patients' perceptions of post-treatment experiences in osteopathy--a qualitative study using focus groups.

Patients commonly report mild to moderate effects following all forms of manual therapy. These are often regarded as adverse events by practitioners but there is limited evidence on how patients view their post-treatment experiences, and what meaning they ascribe to them. This qualitative study used three focus group discussions (19 participants) to explore osteopathic patients' perspectives; a framework approach was used to analyse the data.

Adverse events and manual therapy: a systematic review.

Objective: To explore the incidence and risk of adverse events with manual therapies.

Method: The main health electronic databases, plus those specific to allied medicine and manual therapy, were searched. Our inclusion criteria were: manual therapies only; administered by regulated therapists; a clearly described intervention; adverse events reported.

Reprint of: a preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic.

In this open, controlled, prospective study, 28 infants with colic were randomized to either cranial osteopathic manipulation or no treatment; all were seen once weekly for 4 weeks. Treatment was according to individual findings, and administered by the same practitioner. Parents recorded time spent crying, sleeping and being held/rocked on a 24-h diary.

Defining adverse events in manual therapies: a modified Delphi consensus study.

A pragmatic agreed definition of adverse events in manual therapy is required to explore incidence and prevalence. We aimed to identify and describe such adverse events and seek a consensus definition. A focus group identified issues surrounding the definition of adverse events and generated the content for a questionnaire.

Anticoagulative effects of the inhaled low molecular weight heparin certoparin in healthy subjects.

Inhalation of heparin results in local antiinflammatory and antifibrotic effects and an inhibition of blood coagulation. A number of experimental and clinical studies demonstrated that inhalant administration of heparin or low molecular weight heparin (LMWH) is a feasible and save tool for anticoagulative treatment. However, heparin and LMWH differ in respect to their molecular weight, pulmonary absorption, and principle of their anticoagulative pattern.

Inhalation of tobramycin in patients with cystic fibrosis: comparison of two methods.

Inhalant tobramycin is established in the treatment of cystic fibrosis patients. Conventional nebulizers require a large amount of the expensive compound, because only a small fraction is deposited in the targeted lung region. In contrast, techniques based on controlled inhalation allow a high and reproducible deposition of the drug in specific lung regions.

[Comparison of unspecific bronchial provocation during controlled and spontaneous inhalation].

Using controlled breathing patterns during inhalation of drugs is characterized by a high dose reproducibility which may be of advantage for bronchial provocation testing. In this study 30 healthy subjects with an anamnesis of atopy underwent in a randomized cross-over design bronchial provocation testing with methacholine either with the Viasys-Jäger-APS system or with controlled inhalations (AKITA-System) (controlled inhalation volume and flow). Measured was the frequency of positive test results.

A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic.

In this open, controlled, prospective study, 28 infants with colic were randomized to either cranial osteopathic manipulation or no treatment; all were seen once weekly for 4 weeks. Treatment was according to individual findings, and administered by the same practitioner. Parents recorded time spent crying, sleeping and being held/rocked on a 24-hour diary.

Improvement of alveolar glutathione and lung function but not oxidative state in cystic fibrosis.

Chronic neutrophilic inflammation leads to oxidative damage, which may play an important role in the pathogenesis of cystic fibrosis lung disease. Bronchoalveolar lavage levels of the antioxidant glutathione are diminished in patients with cystic fibrosis. Here we evaluated the effects of glutathione aerosol on lower airway glutathione levels, lung function, and oxidative status.

Pulmonary deposition of monodisperse aerosols in patients with chronic obstructive pulmonary disease.

In order to improve patient convenience and drug availability for patients with alpha 1-protease inhibitor deficiency, the administration via the inhalation route has been considered. This study investigated if it is possible to obtain high values of peripheral aerosol deposition by using optimized and controlled inhalation conditions. Therefore, peripheral deposition was studied in 10 patients with alpha 1-protease inhibitor deficiency (phenotype PiZ) and moderate to severe chronic obstructive pulmonary disease by measuring the 24-hour Clearance of radiolabeled inert iron oxide particles with diameters of 2 microns, 3 microns, and 4 microns.

Peripheral deposition of alpha1-protease inhibitor using commercial inhalation devices.

Patients with hereditary alpha1-proteinase inhibitor (alpha1-PI) deficiency are at risk of developing lung emphysema. To prevent the development of this disease, alpha1-PI replacement therapy via inhalation may be a more convenient and effective therapy than the intravenous administration of the drug. In order to optimise this treatment approach, lung deposition of inhaled radiolabelled alpha1-PI (Prolastin) was studied using four different commercial inhalation devices (PARI-LC Star, HaloLite, and AKITA system in combination with LC Star and Sidestream) in six patients with alpha1-PI deficiency and mild-to-severe chronic obstructive pulmonary disease.

In vitro testing of two formoterol dry powder inhalers at different flow rates.

The efficiency of two different dry powder inhaler systems for the application of the beta2-sympathomimetic drug Formoterol in the lungs has been tested in vitro. Particle size distributions for each device have been measured at four different flow rates (28.3, 40, 60, and 80 L/min) using an Andersen-Impactor.

Increased sputum IL-8 and IL-5 in asymptomatic nonspecific airway hyperresponsiveness.

Since asymptomatic, nonspecific airway hyperresponsiveness (BHR) may be due to an enhanced local inflammatory response, we studied molecular markers of inflammation in induced sputum from subjects with asymptomatic BHR (n = 14) compared with control subjects (n = 13) and patients with chronic obstructive pulmonary disease (COPD) (n = 10). Pulmonary lung function parameters were measured by spirometry and body plethysmography. Hyperresponsiveness was defined based on histamine challenge.

Antenatal administration of betamethasone to prevent respiratory distress syndrome in preterm infants: report of a UK multicentre trial.

In a prospective, randomized, double-blind, multicentre trial the effect of antenatal treatment with betamethasone phosphate was compared with placebo in the prevention of the respiratory distress syndrome (RDS) in preterm infants. The dose of betamethasone was 4 mg every 8 h for six doses, unless delivery occurred. The 251 women who were enrolled gave birth to 262 liveborn infants, 130 in the beta-methasone and 132 in the placebo group; the two groups were evenly matched in most respects.

Acrivastine in allergic rhinitis: a review of clinical experience.

Acrivastine is an antihistamine with reduced sedating potential. This comprehensive review of clinical experience with acrivastine in allergic rhinitis considers all currently available data both published and, as yet, unpublished. Unequivocal evidence of the efficacy of 8 mg acrivastine three times daily for the control of symptoms of seasonal allergic rhinitis has been provided by 11 placebo-controlled studies involving almost 1000 patients.

Responses of human peripheral arteries to agonists: similarities and differences.

A review of the literature indicates that the effects of many vasoactive substances, and particularly alpha agonists, have been investigated in a variety of human peripheral arterial models, including isolated digital, umbilical, uterine, and mesenteric arteries. The limited comparative data on different human arteries, or on animal vs. human arteries, make definition of inter- and intraspecies differences incomplete at this stage.

Treatment of cytotoxic drug-related infections.

Twenty-six patients with a malignancy who were receiving intermittent cytotoxic chemotherapy acquired putative bacterial infections while neutropenic. Fourteen patients with neutrophil counts less than 100 X 10(6)/L received cefuroxime plus amikacin. Twelve patients with neutrophil counts between 100 and 500 X 10(6)/L were given cefuroxime alone.

Cefuroxime: potential use in pregnant women at term.

The placental transfer of cefuroxime was studied in 20 women after one or more 1.5 g intravenous injections. Ten women had labour induced at term and ten were delivered by elective Caesarean section.

Placental transfer of cefuroxime.

The transfer of cefuroxime across the placenta was studied in 10 women in labour and 12 women being delivered by Caesarean section. Following a single intramuscular injection of 750 mg cefuroxime, high antibiotic concentrations were found in the amniotic fluid in women in labour; the peak concentration of 18 mg/l was achieved after five hours. Therapeutic concentrations of cefuroxime were present in umbilical vein serum for up to eight hours after injection.