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PubMed1997

Rapid and automated determination of the beta2-agonist reproterol in human plasma by atmospheric pressure chemical ionisation high-performance liquid chromatography-tandem mass spectrometry.

An on-line HPLC assay with tandem mass spectrometric detection for the fast and sensitive determination of reproterol in human plasma was developed, utilising a methylated structural analogue as the internal standard. Automated solid-phase extraction of diluted plasma samples, based on 250 microl plasma aliquots, at pH 6.5, allowed a reliable quantification of reproterol down to 400 pg/ml. Injection of 100 microl of plasma extracts onto a 30 mm x 4.6 mm reversed-phase guard column provided retention times ranging from 20 to 30 s for reproterol and the internal standard. The standard curves were linear from 0.2 to 200 ng/ml using weighted linear regression analysis (1/y2). The inter-assay and intra-assay accuracies were -0.9% and +3.2%, exhibiting a precision (C.V.) of +/- 11% and +/- 9.3%, respectively. Up to 100 unknowns may be analysed each 24 h per analyst.

Administration, Inhalation↗
PubMed1999

An improved method for the determination of fluticasone propionate in human plasma.

Therapeutic monitoring of the potent, highly lipophilic glucocorticoid, fluticasone propionate (FP), was initially performed by a radioimmunoassay method. However an improved method with a lower limit of quantitation (LLOQ) of at least 25 pg per ml (pg/ml(-1)) was needed to measure the low levels of FP present in human plasma following inhalation administration of doses in the range 50-250 microg twice daily. A sensitive and specific liquid chromatographic, tandem mass spectrometric method (LC-MS/MS) with automated solid phase extraction (SPE) was developed and validated. Fluticasone propionate was extracted from plasma using Bond Elut C18 cartridges and analysed using reverse-phase chromatography with atmospheric pressure chemical ionisation followed by selective reaction monitoring. The method used a 13C-labelled internal standard and was validated over a concentration range of 25-500 pg/ml(-1). The method was shown to be specific, sensitive and reliable in the analysis of clinical samples. The main advantages of this method over the radioimmunoassay method previously used were improved sensitivity, specificity, ease of sample preparation and shortened analysis time.

Androstadienes↗
PubMed2003

The enzyme as drug: application of enzymes as pharmaceuticals.

Enzymes as drugs have two important features that distinguish them from all other types of drugs. First, enzymes often bind and act on their targets with great affinity and specificity. Second, enzymes are catalytic and convert multiple target molecules to the desired products. These two features make enzymes specific and potent drugs that can accomplish therapeutic biochemistry in the body that small molecules cannot. These characteristics have resulted in the development of many enzyme drugs for a wide range of disorders.

Adenosine Deaminase↗
PubMed2000

Topical amphotericin B application in severe bronchial aspergillosis after lung transplantation: report of experiences in 3 cases.

Ulcerative tracheobronchial aspergillosis after lung transplantation (ltx) may lead to bronchial-pulmonary artery fistula that results in fatal bleeding. We report our early experience with combined systemic, aerolized and topical application of amphotericin B in 3 cases of bronchial aspergillosis after ltx. Two patients are still alive, but 1 died of bleeding from a fistula between the left upper lobe bronchus and the pulmonary artery. Aspergillosis in the second patient resolved with minimal stenosis of the left main and the left upper lobe bronchus, and the third patient developed an anastomotic stenosis that was successfully dilated.

Administration, Inhalation↗
PubMed2006

Comparison of fluticasone propionate aqueous nasal spray and oral montelukast for the treatment of seasonal allergic rhinitis symptoms.

BACKGROUND: Few studies have directly compared the efficacy of intranasal corticosteroids with that of leukotriene receptor antagonists for the treatment of daytime and nighttime symptoms of seasonal allergic rhinitis (SAR). OBJECTIVE: To compare fluticasone propionate aqueous nasal spray, 200 microg daily, with oral montelukast, 10 mg daily, for the relief of SAR symptoms. METHODS: Patients with SAR 15 years or older were randomized to receive either fluticasone propionate (n = 367) or montelukast (n = 369) in this double-blind, double-dummy, parallel-group study. The primary efficacy measure was the mean change from baseline in daytime total nasal symptom scores (TNSSs) (the sum of 4 daytime individual nasal symptom scores [INSSs] assessing nasal congestion, itching, rhinorrhea, and sneezing), averaged across weeks 1 and 2. Secondary efficacy measures included the 4 daytime INSSs, nighttime TNSSs (the sum of 3 nighttime INSSs assessing congestion on awakening, difficulty going to sleep, and nighttime awakenings), and the 3 nighttime INSSs averaged across weeks 1 and 2. RESULTS: Mean changes from baseline in daytime TNSSs (P < .001), all daytime INSSs (P < .001), nighttime TNSSs (P < .001), and all nighttime INSSs (P < or = .02) showed significant differences favoring fluticasone propionate over montelukast across 2 weeks of treatment. CONCLUSION: Compared with montelukast, fluticasone propionate provided significantly greater improvement in daytime and nighttime SAR symptoms.

Acetates↗
PubMed1997

Azelastine nasal spray as adjunctive therapy to azelastine tablets in the management of seasonal allergic rhinitis.

BACKGROUND: Azelastine rhinitis medications (nasal spray and tablets) have been shown to relieve the symptoms of allergic rhinitis. Nevertheless, many rhinitic subjects suffer from acute exacerbations of symptoms that sometimes require additional treatment. OBJECTIVE: To assess the efficacy and safety of azelastine nasal spray as adjunctive therapy to azelastine tablets in the management of symptomatic seasonal allergic rhinitis in subjects who remain symptomatic despite the oral medication. METHODS: A 2-day, randomized, multicenter, double-blind, placebo-controlled, parallel-group study. Two hundred thirty-three subjects with symptomatic allergic rhinitis received azelastine tablets (0.5 mg bid) for a minimum of seven days prior to receiving either azelastine nasal spray (2 sprays per nostril bid) or placebo nasal spray as adjunctive therapy. Efficacy was determined by improvement in rhinitis symptoms that were grouped according to total and major symptom complex severity scores. RESULTS: Mean percent improvements in the total symptom complex severity scores for azelastine were statistically significant (P < or = .05) or showed a trend toward statistical significance (.05 < or = P < .10) versus placebo from the second through the first ten hours after the initial dose and for each of the last five hours of the second day, demonstrating a rapid onset of action and sustained efficacy over the 2-day study period. Azelastine was well tolerated, and no subject discontinued therapy with azelastine due to an adverse experience. CONCLUSION: Azelastine nasal spray can be effectively administered as adjunctive therapy, in an outdoor environment in which subjects are exposed to pollen and other aeroallergens.

Administration, Inhalation↗
PubMed1996

Controlled-release theophylline inhibits early morning airway obstruction and hyperresponsiveness in asthmatic subjects.

BACKGROUND: Nocturnal asthma reflects the severity of the disease, and thus its pharmacologic prevention represents one on the main goals of asthma management. SUBJECTS AND METHODS: To determine whether controlled-release theophylline inhibits the development of airway obstruction and/or airway hyperresponsiveness early in the morning, we examined 18 subjects reporting recurrent nocturnal asthma. In each subject, after five days' treatment with an 8 PM increasing dose of oral controlled-release theophylline, up to 10 +/- 1 mg/kg or placebo the night before the study day, we measured serum theophylline, FEV1 and PC20FEV1 at 6 AM, 2 PM and 10 PM. RESULTS: At 6 AM, both FEV1 and PC20FEV1 were significantly higher on theophylline than on placebo (3.52 +/- 0.22 versus 3.17 +/- 0.25 L; P < .005 and 2.76 divided by 3.61 versus 1.55 divided by 3.73 mg/mL; P < .05, respectively). At 2 PM and 10 PM FEV1, but not PC20FEV1, was higher on theophylline than on placebo (3.73 +/- 0.21 versus 3.54 +/- 0.25 L; P < .05 and 3.40 +/- 0.22 versus 3.24 +/- 0.24 L; P < .05). Serum theophylline was 12.8 +/- 1.1 micrograms/ml, 8.9 +/- 0.77 and 9.5 +/- 0.85 at 6 AM, 2 PM and 10 PM, respectively. CONCLUSIONS: We conclude that an evening dose of controlled-release theophyl line inhibits early morning airway obstruction and hyperresponsiveness, and that it may be helpful in the prevention of nocturnal asthma.

Administration, Inhalation↗
PubMed2006

Concerns about intranasal corticosteroids for over-the-counter use: position statement of the Joint Task Force for the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology.

The Joint Task Force for the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology was charged with formulating a position paper regarding the potential release of intranasal corticosteroids for over-the-counter use. We took the position that safety issues regarding this proposal would be our sole concern. We reviewed the literature to evaluate the frequency and severity of potential adverse events related to the administration of intranasal corticosteroids. We limited this review to 5 areas: (1) effects on growth, (2) ocular effects, (3) effects on bone, (4) effects on the hypothalamic-pituitary-adrenal axis, and (5) local adverse effects. After review of the available data, we concluded that intranasal corticosteroids should remain prescription-only drugs. Patients receiving an intranasal corticosteroid should be instructed in its use and that use should be monitored by a physician or an appropriately trained medical provider (eg, nurse practitioner or physician assistant) under the direct supervision of a physician. This conclusion was reached based on the evidence that corticosteroids administered by any route, including the intranasal route, have the potential to cause adverse effects in all the areas noted herein. Our conclusion was strengthened by the fact that these adverse effects can be insidious and therefore not evident for many years; there is the potential for overuse; patients could also have access to other forms of topically administered corticosteroids, thus increasing their total dose; and individuals vary in their susceptibility to corticosteroid-induced adverse effects. We were also influenced to take this position knowing that generally reassuring data regarding the use of respiratory tract-administered corticosteroids are based on mean data and that all such studies have shown outliers in whom adverse effects were evident. Thus, as stated, we recommend that intranasal corticosteroids remain prescription-only drugs.

Administration, Inhalation↗
PubMed2004

Critical incident: idiosyncratic allergic reactions to essential oils.

Essential oils have the potential to initiate allergic reactions due to their volatile and skin absorbent nature. Practitioners and aromatherapy teachers need to be aware of the potential for allergies and be equipped to deal with them if they should arise. Two cases are presented of potentially serious reactions that occurred within a learning situation along with a brief literature critique about allergic reactions to essential oils.

Administration, Inhalation↗
PubMed2003

Intranasal IL-12 produces discreet pulmonary and systemic effects on allergic inflammation and airway reactivity.

IL-12 modulates T cell responses between helper T cells Th2 and Th1; however, the therapeutic potential of IL-12 for allergic diseases either directly or as an adjuvant in allergen therapy has been controversial. The role of intranasal IL-12 as an adjuvant in modulating the grass pollen allergen (GAL) therapy-induced systemic immune response and lung-specific inflammation and airway reactivity was examined in this study using a mouse model of established allergic asthma. The effects of intranasal or nebulized IL-12 with or without intranasal anti-IFN-gamma antibody were examined in groups of control and allergen-sensitized or -challenged mice. T cell cytokine patterns, antibody response profiles, pulmonary inflammation and airway reactivity were examined. Intranasal IL-12 was found to be more effective in the Th2-Th1 shifting of immune response and anti-inflammatory activity in the lung compared to nebulized IL-12 at the given doses. Intranasal IL-12 significantly decreased production of IFN-gamma, eotaxin and LTC4/D4/E4 in the lung and decreased eosinophil infiltration, resulting in attenuated airway hyper-responsiveness in GAL-sensitized (GS) mice. In contrast, intranasal IL-12 significantly increased IFN-gamma production in the thoracic lymph node cultures and decreased the IL-5/IFN-gamma ratio, suggesting a Th2-Th1 shift. Also, intranasal IL-12 increased GAL-specific IgG2a antibody response, while the IgE response remained unaffected. The systemic effects of IL-12 were IFN-gamma dependent. IL-12 induces differential expression of its own receptor beta1 and beta2 subunits in the lung tissues to augment IL-12 responsiveness. Together, these results demonstrate that intranasal IL-12 is effective in shifting the systemic immune response in the direction of Th1 in IFN-gamma-dependent manner, while decreasing pulmonary inflammation and airway reactivity independent of IFN-gamma. Thus, intranasal delivery of IL-12 may provide an approach for the treatment of asthma and may be useful as an adjuvant in local nasal immunotherapy (IT) and in asthma.

Adjuvants, Immunologic↗
PubMed1996

Preliminary physiologically based pharmacokinetic model for cocaine in the rat: model development and scale-up to humans.

A physiologically based multicompartmental model has been developed to describe the concentration-time course of cocaine in plasma and tissues in the rat. The compartments included in the model were brain, heart, gut, liver, muscle, fat, venous blood, arterial blood, and a mass-balance compartment. Drug delivery to the tissues was assumed to be flow limited. The model incorporated a nonsaturable binding site for cocaine in the liver. Elimination occurred via both blood and hepatic elimination. The model was validated using independently derived data. The model was scaled to humans and accurately predicted the cocaine levels following intranasal and inhalation administration. However, a poor fit was observed following intravenous administration. Future models incorporating non-constant blood flow and pharmacodynamics need to be developed.

Animals↗