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PubMedDate not supplied

Beclomethasone dipropionate versus budesonide inhalation suspension in children with mild to moderate persistent asthma.

Inhaled steroids are the most effective long-term treatment of persistent asthma but many children are unable to use correctly the available inhalers. Administration of nebulized corticosteroids has some advantages over the administration with pressurised metered-dose inhalers (pMDls). The objective of this multicenter randomised study was to compare the efficacy and tolerability of nebulized corticosteroids in paediatric patients with asthma. 127 patients aged > or = 6 and < or = 14 years with a diagnosis of mild to moderate persistent asthma (PEFR % predicted > 50% and < 85%) and positive response to the reversibility test were randomized. The patients were assigned by randomisation to one of the two treatment groups (4 weeks): beclomethasone dipropionate (BDP) 800 microg/daily b.i.d. (n = 66) or budesonide (BUD) 1000 microg/daily b.i.d. (n = 61) both administered by nebulizer. The primary efficacy end point was the final mean of PEFR measured at clinical visit (clinic PEFR). In the BDP group clinic PEFR increased from 177.5 +/- 80 L/min to 246.6 +/- 84.2 L/min (p < 0.001 vs baseline), while in the BUD group the increase was from 180.4 +/- 77.8/min to 260.9 +/- 84.1 L/min (p < 0.001 vs baseline) (NS between treatments). FEV1 (% predicted) increased from 77.8% to 92.7% (p < 0.001 vs baseline) and from 74.1% to 95.9% (p < 0.001 vs baseline) in BDP and BUD group respectively (NS between treatments). Patients reduced the use of salbutamol rescue medication by 76% and 81% in BDP and BUD group respectively (p < 0.001 vs baseline, NS between treatments). 4 patients in the BDP group and 2 in the BUD group reported adverse events (AEs). AEs were mild to moderate and never there was the need to discontinue the treatments. In conclusion the results of this study demonstrate that both BDP (800 microg/daily) and BUD (1000 microg/daily) administered by nebulization are effective and with a acceptable safety and tolerability profile.

Administration, Inhalation↗
PubMedDate not supplied

Lipid peroxidation and antioxidant enzyme activities in the rat testis after cigarette smoke inhalation or administration of polychlorinated biphenyls or polychlorinated naphthalenes.

Lipid peroxidation products and antioxidant enzyme activities were studied in the rat testis following exposures to cigarette smoke, polychlorinated biphenyls (PCBs), or polychlorinated naphthalenes (PCNs). Three hours after a single 1-hour period of smoke inhalation, the levels of fluorescent chromolipids and thiobarbituric acid-reactive species (TBARS) were markedly increased in the testis (+49%, P < 0.01, and +43%, P < 0.05, respectively). Twelve hours after daily smoking for 1 hour, for 1, 5, or 10 days, such an increase was not found. Activities of the antioxidant enzymes superoxide dismutase (SOD), catalase, glutathione peroxidase (GSH-Px), glutathione transferase (GSH-Tr), or hexose monophosphate shunt (HMS) were not affected immediately, 3 hours, or 12 hours after a single smoking session. Twelve hours after smoking for 5 days, the activity of catalase was decreased (-16%, P < 0.05). Smoking exposures had no consistent effects on serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), or testosterone concentrations. Single i.p. injections of PCB or PCN mixtures resulted in decreases in testicular SOD activity 1 day after the exposures (-14%, P < 0.05, and -51%, P < 0.01, respectively). Catalase activity also decreased after both exposures (-30 to -42%, P < 0.05, at days 1-7 after PCB exposure, and -37 to -43%, P < 0.05, at days 3-7 after PCN exposure). Ninety days after the PCN exposure, activities of GSH-Px and GSH-Tr were decreased in the testis (-20%, P < 0.05, and -26%, P < 0.05, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1999

Pharmacological activities of TEI-8362, a novel inhibitor of human neutrophil elastase.

1. TEI-8362, 4-(N-(3-((3-carboxypropyl)amino)-8-methyl-1-oxo-4-azaisochromen-6- yl)carbamoyl)-4-((phenylmethoxy)carbonylamino)butanoic acid (C26H28N4O9) is a novel inhibitor of human neutrophil elastase (HNE). We evaluated its pharmacological profile in vitro and in vivo. 2. TEI-8362 demonstrated potent inhibition of HNE with a Ki value of 1.38 x 10(-9) M. Its selectivity for HNE among a variety of proteases ranged from 163 fold to 68,000 fold in favour of HNE. 3. The pulmonary haemorrhage that occurred after i.t. instillation of HNE to hamsters was inhibited by either i.t., i.v., or inhalant administration of TEI-8362. 4. Intratracheal administration of lipopolysaccharide induced pulmonary neutrophilia. Twenty-four hours after lipopolysaccharide administration, the additional treatment with formyl-methionyl-leucyl-phenylalanine resulted in a specific neutrophil-dependent acute lung injury. In this model, lung injury was significantly attenuated by i.t., i.v., or inhalant administration of TEI-8362. 5. These pharmacological actions of TEI-8362 suggest that this drug has therapeutic value in the treatment of destructive lung diseases due to neutrophils.

Animals↗
PubMed1990

The self-administration of inhaled beta agonist drugs during severe asthma.

Interviews were conducted with 101 consecutive adult patients admitted to Wellington Hospital with a diagnosis of asthma to assess the extent to which beta agonist drugs are self-administered by asthmatic patients during severe asthma. The 99 patients prescribed an inhaled beta agonist were subdivided into two groups: group A comprising 79 patients prescribed a beta agonist for inhalation via an inhaler (metered dose aerosol or dry powder device) alone; group B comprising 20 patients prescribed beta agonist for inhalation via both an inhaler and nebuliser. In group A, the attacks of asthma lasted greater than 24 hours in 64/79 patients, and 22% of these patients reported taking more than 60 doses of their inhaler, and 52% more than 30 doses during the 24 hr period prior to admission. In group B, the attacks of asthma lasted greater than 24 h in 17/20 patients, and 35% of these patients self-administered their nebuliser more than six times, and 76% more than four times during the 24 h period prior to admission. In addition to their nebuliser use, these patients also took a median 23 doses of their inhaler during this 24 h period. This use of inhaled beta agonist contrasts with the recommended practice in both the USA and Europe, where most physicians recommend no more than 15 doses of a beta agonist as the maximal dose per day. We conclude that asthmatic patients in New Zealand self-administer high doses of inhaled beta 2 agonist drugs during severe exacerbations of asthma.

Adolescent↗
PubMed1981

How important is the sequence of administration of inhaled beclomethasone dipropionate and salbutamol in asthma.

Sixty patients with fairly stable asthma of mild or moderate severity entered a multicentre, double-blind cross-over trial, comparing the efficacy of inhaled beclomethasone dipropionate preceded 10 minutes earlier by inhalation of salbutamol with that of beclomethasone followed 10 minutes later by salbutamol during two consecutive three-month periods. Patients received beclomethasone 100 microgram and salbutamol 200 microgram four times daily. Analysis of occurrence of exacerbations, usage of additional inhaled salbutamol, peak expiratory flow rate and symptom scores showed no evidence that regular beclomethasone was more effective when preceded by salbutamol rather than when followed by it.

Adult↗
PubMed1999

Absolute oral versus inhaled bioavailability: significance for inhaled drugs with special reference to inhaled glucocorticoids.

Orally inhaled drugs provide great benefit in the treatment of asthma as they are delivered directly to the site of action, i.e. the lung. The absolute oral inhaled bioavailability of a glucocorticoid results from the combination of the bioavailability of the dose delivered to the lung and the bioavailability of the dose delivered into the gastrointestinal (GI) tract. The majority of the dose delivered to the lung is absorbed and available systemically. For the portion of the glucocorticoid dose delivered orally, bioavailability depends upon absorption from the GI tract and the extent of first pass/pre-systemic metabolism in the GI tissue and liver. Since this oral component of the delivered dose does not provide any beneficial therapeutic effect but can contribute to the systemic side effects, it is desirable for the absolute oral bioavailability of inhaled glucocorticoids to be relatively low (which is the case with most of the glucocorticoids, < 25%). Another approach to limiting systemic exposure from inhaled delivery is to improve the effectiveness of the oral inhaled formulation and delivery device, by increasing the fraction of the total inhaled dose which reaches the lung. Since current inhalation technology can provide respirable fractions in the range of 30-50%, what is the significance of the oral component of systemic exposure in relation to the overall systemic exposure following the oral inhalation administration of glucocorticoids? Below a certain point (approximately 25%), lower oral bioavailability of inhaled drugs may not be clinically important with respect to systemic exposure if the lung targeting is good (30%).

Administration, Inhalation↗
PubMed1988

Comparison of blood toluene levels after inhalation and oral administration.

The purpose of this investigation was to compare blood toluene levels in Sprague-Dawley rats after oral and inhalation administration. Groups of 30 rats were dosed by gavage with 86.7, 217, 433, or 867 mg toluene/kg body wt or exposed for up to 6 hr, 5 rats per exposure, to an atmosphere of either 200 or 1000 ppm toluene. Blood was sampled by cardiac puncture from 5 rats in each of the six dose groups at 0.5, 1.0, 2.0, 4.0, 6.0, and 24.0 hr after gavage dosing or the beginning of the inhalation exposure. Blood toluene levels were analyzed. A four-parameter model was fitted to the blood toluene levels of the orally dosed rats. The area under the curve generated by this model, representing total blood toluene concentration over 6 hr, was calculated and compared to the area under the blood toluene curve for the 6-hr inhalation exposure. Integrated areas from the two routes of exposure were used for direct comparison of oral and inhalation exposures. The data demonstrate that gavage dosing can be used to approximate inhalation exposure to toluene.

Administration, Inhalation↗
PubMed2000

Nebulised anti-pseudomonal antibiotics for cystic fibrosis.

BACKGROUND: Lung damage associated with persistent infection by Pseudomonas aeruginosa is the major cause of morbidity and mortality in people with cystic fibrosis. Nebulised antibiotics are commonly used for treatment of this infection. OBJECTIVES: To examine the evidence that nebulised anti-pseudomonal antibiotic treatment in patients with cystic fibrosis reduces frequency of exacerbations of infection, improves lung function, quality of life and survival. To assess adverse effects of nebulised anti-pseudomonal antibiotic treatment. SEARCH STRATEGY: Trials were identified from the Cochrane Cystic Fibrosis and Genetic Disorders Group clinical trials register. Companies which marketed nebulised anti-pseudomonal antibiotics were contacted for information on unpublished trials. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: Trials were selected if, nebulised anti-pseudomonal antibiotics treatment was used in patients with cystic fibrosis, treatment was used for four weeks or more, allocation to treatment was randomised or pseudo-randomised, and there was a placebo or a no placebo control group. DATA COLLECTION AND ANALYSIS: References to nebulised antibiotics were retrieved from the register. Two reviewers independently selected trials from this sample according to the criteria. Each judged the quality of selected trials. One reviewer extracted data from these trials. MAIN RESULTS: Ten trials with 758 participants were included in the review. Sixty eight % of participants were in one trial. Duration of trials ranged from one to 32 months. There was large variation in study design and outcome measures which limited meta-analysis. Lung function measured as forced expired volume in one second (FEV1) was generally better in the treated groups than in control groups but a pooled estimate of effect was not possible. In the largest trial of 520 participants the FEV1 was 11.9% predicted (95% confidence interval 8.1to 15.6) higher in the treated group than in the placebo control group after 5 months. In three trials with 581 participants the number of participants having at least one hospital admission during a trial was reduced in the groups treated with nebulised antibiotics, odds ratio 0.69 (95% confidence Interval 0.50 to 0.96). In two trials with 591 participants the number of participants having and at least one course of antibiotic therapy was reduced in the treated group, odds ratio 0.62 (95% confidence interval 0.45 to 0.87). There was no evidence of renal or auditory toxicity. Resistance to antibiotic increased more in the antibiotic treated group than in placebo group. The most evidence for a single drug is for tobramycin, which was used in total daily doses from 40mg to 1800mg. REVIEWER'S CONCLUSIONS: Nebulised anti-pseudomonal antibiotic treatment improves lung function and reduces frequency of exacerbations of infection in people with cystic fibrosis. There is a need for more evidence for effect on quality of life and survival, for longer duration trials to determine if this benefit is maintained and to determine the significance of development of antibiotic resistant organisms.

Administration, Inhalation↗
PubMedDate not supplied

The potential value of a 750-ml spacer for the administration of inhaled corticosteroids to children.

An open, cross-over trial was conducted on 25 asthmatic children, aged 6-13 years, who required inhaled steroids. They inhaled Budesonide 200 micrograms twice daily, either directly from the metered dose inhaler or via the pear spacer (PS), for 2 months on each, in randomized order. The effects of the treatment were monitored with diary cards recording peak expiratory flow rates twice daily, symptoms and treatment taken, and with monthly clinical assessments including more sensitive lung function studies (flow-volume loops and single breath nitrogen wash-out tests). There was no specifically PS-related improvement in symptoms or in the majority of tests, but the results showed improvement with time when using either method. The improvement was more distinct in some tests reflecting proximal airway calibre (i.e., PEFR) than in tests thought to reflect predominantly peripheral airway calibre (i.e., F50, RV). The bronchodilator responsiveness, as shown by the increase in lung function tests after a beta-agonist was given, was significantly greater for FVC during the periods when the PS was used, although there was no significant improvement in FEV2 or PEFR. The improvement in tests reflecting proximal airways may have been due to optimization of the inhalation technique, greater understanding of asthma, or better compliance with medication associated with regular attendance for the study. The greater bronchodilator response whilst children were inhaling budesonide by the PS may have been due to increased deposition or better distribution of the steroid but was probably related to a difference between the two groups in initial baseline function tests.

Adolescent↗
PubMed1997

[Intrabronchial surfactant administration in inhalation trauma of severely burned patients with ARDS. Initial case reports].

Damage to the respiratory system caused by inhalation of toxic products of combustion and the subsequent development of adult respiratory distress syndrome (ARDS) are the main lethal factors in burns patients. Treatment with exogenous surfactant is one of the therapeutic options. However, no clinical reports have yet been published about this therapy. We report on two patients with burn injuries of second to third degree affecting 42% and 48% respectively of the total body surface plus inhalation injury complicated by ARDS. Both patients were treated with bovine surfactant (Alveofact). The therapeutic effects on oxygenation and pulmonary function were monitored. Intrabronchial application of surfactant by bronchoscopy during exhaustive conventional mechanical ventilation resulted in improved gas exchange with an increase in arterial O2 pressure (paO2); inspired O2 concentration (FiO2) was lowered and there was an improvement in lung compliance. Both patients survived this critical situation. We conclude that treatment with exogenous surfactant in postburn victims with ARDS is a promising therapeutic approach to improve the survival rate of these high-risk patients.

Adult↗
PubMed2001

Model-based administration of inhalation anaesthesia. 2. Exploring the system model.

We explored our model by displaying its new capabilities, testing its sensitivity to variations in input data and illustrating its use. Its multiple-gas character allows simulation of the mechanisms governing concentration and second gas effects. Simulating the volume of a standing bellows makes it possible to test algorithms for automated closed-circuit anaesthesia. Using desflurane, the model's sensitivity to changes in blood/gas partition coefficient (range 0.42-0.576), cardiac output and minute ventilation was analysed. The model was very sensitive to changes in blood solubility; other results agreed with those reported previously. An alveolar isoflurane tension of 1% atm was rapidly attained and maintained, even using 0.5 litres min(-1) of fresh gas, when isoflurane was 'co-administered' through a vaporizer set to 3.5 vol% and a single aliquot (1.25 ml liquid) injected into the expiratory limb. As a result of its credibility and capabilities, the model is to be tested in the clinical setting.

Algorithms↗