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PubMed1994

Effects of route and formulation on clinical pharmacokinetics of interleukin-2.

Interleukin-2 (IL-2) is a hormone of the immune system responsible for control of the proliferation and cytotoxicity of T lymphocytes and natural killer cells as well as the proliferation of B lymphocytes. Recombinant IL-2 has been only minimally to modestly successfully to date in the treatment of cancer and infectious diseases, largely because the drug is associated with toxicity and a narrow therapeutic index. Quantitative measurement of IL-2 can be quickly done by enzyme immunoassay. IL-2 bioassay provides an index of biologically active cytokine. IL-2 action and pharmacokinetics can be understood in the context of the effect IL-2 on high (alpha, beta, gamma trimer) vs intermediate (alpha, beta) vs low (beta only or alpha only) affinity IL-2 receptors on various cells of the immune system. IL-2 undergoes rapid renal elimination. The route of administration is important to determine the provision of sustained drug concentrations adequate to support the proliferation and cytotoxicity of immune cells. When IL-2 is given intravenously it has rapid elimination pharmacokinetics with an initial elimination half-life and terminal elimination half-life (t1/2 beta) of 6 to 12 minutes and 40 to 80 minutes, respectively. Subcutaneous or intramuscular administration of IL-2 results in sustained systemic absorption and approximately 30% of the injected dose is absorbed. Because IL-2 is less rapidly cleared from the site of intracavitary injection, when the drug is given by these less traditional routes (e.g. intraperitoneal, intrapleural, intrathecal, intraventricular, intravesicular, and inhalational administration) sustained local IL-2 activity can result. In some cases this has resulted in an improved therapeutic index compared with that resulting after administration of the drug by high dose intravenous bolus or continuous infusion. Depot IL-2 preparations may offer more convenient administration (e.g. t1/2 beta of polyethylene glycolated IL-2 is approximately 10-fold higher than that of recombinant IL-2) or more favourable biodistribution (e.g. IL-2 liposomes are more potent against lung metastases) compared with IL-2 administered by more conventional routes. An understanding of IL-2 clinical pharmacokinetics in relation to immunobiology of this central cytokine should lead to less toxicity and more effective clinical use.

Amino Acid Sequence↗
PubMed1992

Central noradrenergic activity and the cardiovascular effects of nitroglycerin and amyl nitrate.

Intracerebroventricular and i.v. administration of nitroglycerin in anesthetized Sprague-Dawley rats produced dose-dependent decreases in mean arterial pressure and increases in heart rate, but intracisternal injection of the drug induced hypotension and bradycardia. Hypotensive responses to intracisternal injection of nitroglycerin showed that the compound was two to three times more potent than by i.v. administration (six times when comparing the area under the curve). Intravenous sodium nitroprusside produced dose-dependent hypotensive and tachycardiac effects, but minimal responses were induced by i.c.v. and intracisternal injection. Central pretreatment with either yohimbine or rauwolscine antagonized hypotensive responses to i.c.v. and i.v. nitroglycerin, but did not alter the depressor responses induced by i.v. sodium nitroprusside. Tachycardiac responses to i.c.v. nitroglycerin are greater than the responses induced by i.v. administration. Inhalation of amyl nitrite produced marked hypotensive responses, with the dose-response curves being shifted to the right by i.c.v. pretreatment with rauwolscine, but not by i.v. pretreatment. The concentrations of 3,4-dihydroxyphenylglycol and 3-methoxy-4-hydroxyphenylglycol in cerebrospinal fluid were increased by i.v., i.c.v., and intracisternal administration of nitroglycerin, but were not altered by i.v. sodium nitroprusside. The concentrations of dihydroxyphenylacetic acid were elevated by i.v. and i.c.v. injection of nitroglycerin. Results suggest that nitroglycerin stimulates central noradrenergic activity, which may be involved in the component of hypotensive effects of the drug. Reflex tachycardiac responses to nitroglycerin may be further complicated by forebrain stimulation and medulla-mediated bradycardia. Sodium nitroprusside did not demonstrate central activity.

Animals↗
PubMed2005

Effects of inhaled nitric oxide administration on early postoperative mortality in patients operated for correction of atrioventricular canal defects.

OBJECTIVE: Postoperative pulmonary hypertension (POPH) substantially increases mortality after repair of congenital heart diseases. Inhaled nitric oxide (NO) has been reported as an effective and specific means of controlling POPH crisis. No randomized, placebo-controlled study has addressed the ability of NO administration to reduce mortality. Such a trial could raise ethical questions. DESIGN: Observational study with historical control subjects based on multivariate confounder scores. SETTING: Surgical pediatric ICU in a university hospital. PATIENTS: Two hundred ninety-four records of patients operated on for atrioventricular (AV) canal between 1984 and 1994 who presented with severe POPH. INTERVENTIONS: All variables found to be predictive for death by univariate tests were entered in a multivariate forward stepwise logistic regression model. Two paired groups regarding risk factors for death and only differing for POPH treatment (NO or conventional treatment) were constructed on the basis of predicted values obtained from this model. Twenty-five patients received NO, and 39 control patients, operated on between 1984 and 1994, received conventional treatment for POPH. MEASUREMENTS AND RESULTS: Postoperative pulmonary pressure, date of operation, and occurrence of an infectious complication were retained in the model. The comparison between the two paired groups showed a significant difference in mortality (24%; 95% confidence interval [CI], 7 to 41%; vs 56%; 95% CI, 37 to 75%, respectively; p = 0.02). CONCLUSIONS: This study suggests that there is a high probability for postoperative mortality reduction associated with administration of inhaled NO when severe POPH occurs in children operated for complete repair of AV canal.

Adolescent↗
PubMed2004

Transdermal absorption of (-)-linalool induces autonomic deactivation but has no impact on ratings of well-being in humans.

Essential lavender oil has a long tradition as a mild sedative in herbal medicine. Relaxing effects after inhalation have also been demonstrated for one of its main constituents, (-)-linalool. The aim of the present investigation was to determine the effects of this monoterpenoid alcohol on human physiological parameters (blood oxygen saturation, breathing rate, eye-blink rate, pulse rate, skin conductance, skin temperature, surface electromyogram as well as systolic and diastolic blood pressure) and assessments of subjective well-being. (-)-Linalool was applied to 14 healthy subjects by percutaneous administration. Inhalation of the fragrance was prevented by means of breathing masks. (-)-Linalool induced deactivation with respect to physiology, that is, a decrease of systolic blood pressure and a smaller decrease of skin temperature, compared to a corresponding control group receiving a placebo, but had no effects on subjective evaluation of well-being.

Acyclic Monoterpenes↗
PubMed2006

Respiratory Drug Delivery X. Boca Raton, FL, USA, 24-27 April 2006.

There were approximately 700 delegates who attended Respiratory Drug Delivery X (RDD-X) at the Boca Raton Resort and Club in Boca Raton, Florida, between the 24th and 27th April 2006. Participants from North America, Europe and many other parts of the world came together to hear a series of invited podium presentations covering the latest scientific developments in pulmonary and nasal drug delivery, along with regulatory and quality control issues. A total of 150 proffered posters were also presented, and a Technology Exhibition involved the products of 78 companies. The conference also provided unparalleled networking opportunities. The proceedings of RDD-X will prove to be an invaluable resource for years to come.

Administration, Inhalation↗
PubMed1997

[Inhalation route for administration of systemic drugs].

With aerosolized administration of medicines, direct access to the lung is possible. Depending on the intrapulmonary behavior of each molecule, the aerosol mode of administration makes possible either a pulmonary topical action or a systemic action, thanks to the lung's wide vascular network. An inhaled molecule's pulmonary behavior is not predictable and must be studied on its own. Some medicines with a systemic aim have a topical effect after aerosol administration: furosemide, amiloride, morphine, interferons, cyclosporin and prostacyclin. Other medicines have systemic effects after aerosol administration: insulin, growth hormone, LHRH, calcitonin and nicotine. Heparin can be classified in either group depending on the dose and type of use.

Administration, Inhalation↗
PubMed2005

Breakpoints for predicting Pseudomonas aeruginosa susceptibility to inhaled tobramycin in cystic fibrosis patients: use of high-range Etest strips.

Inhaled administration of tobramycin assures high concentrations in cystic fibrotic lungs, improving the therapeutic ratio over that of parenteral tobramycin levels, particularly against Pseudomonas aeruginosa. Conventional Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards) breakpoints only consider parenteral levels and do not take into account these high antimicrobial concentrations. The Spanish Antibiogram Committee (The MENSURA Group) has tentatively defined specific breakpoint values for inhaled tobramycin when testing P. aeruginosa isolates from cystic fibrosis (CF) patients (susceptible, < or =64 microg/ml; resistant, > or =128 microg/ml). The antimicrobial susceptibilities of 206 prospectively collected CF P. aeruginosa isolates were determined by the reference agar dilution method. For tobramycin, the performance of high range tobramycin Etest strips (AB Biodisk, Solna, Sweden) and conventional tobramycin disks were assessed with the same collection. Applying MENSURA proposed breakpoints, 95.1% of the strains were categorized as susceptible to tobramycin, either using agar dilution or Etest high-range strips (99% categorical agreement between both methods). With CLSI breakpoints, susceptibility rates decreased to 79.1 and 81.1% for agar dilution and Etest strips, respectively (83.5% categorical agreement). Minor, major, and very major errors for Etest strips (CLSI criteria) were 13.6, 1.2, and 14.8%, respectively. Upon applying the new proposed criteria for inhaled tobramycin, only one major and one very major error were observed with Etest strips. Whenever inhaled tobramycin is considered for therapy, we suggest that P. aeruginosa strains from CF patients categorized as intermediate or resistant to tobramycin according to the CLSI criteria should be retested with high-range Etest strips and recategorized using MENSURA interpretive criteria. CLSI breakpoints should still be followed when intravenous tobramycin is used in CF patients, particularly during the course of exacerbations.

Anti-Bacterial Agents↗
PubMed1998

Genetic effects of 1,3-butadiene on the mouse testis.

1,3-Butadiene is a known male mouse germ-cell mutagen, to which humans may either be occupationally or environmentally exposed. Prolonged exposure to moderate or high doses in male mice can cause dominant lethal mutations and one report has indicated that 10 week inhalation administration of low doses can result in the production of malformed foetuses. The present study had dual purposes: (a) to attempt to clarify the suspected ability of sub-chronic (6 h/day, 5 days/wk, 10 weeks) low-dose exposure to 1,3-butadiene to induce heritable mutations in mouse male germ cells: (b) investigation of the relationships between testicular DNA damage, testicular DNA repair and foetal outcome. Adult male mice were exposed to low or moderate doses of 1,3-butadiene by inhalation sub-chronically or for a single 6 h period and either used for mating (sub-chronic exposure only) or for studies of DNA damage and repair. Litter size, dominant lethality and numbers of abnormal foetuses were determined the day preceding the normal day of parturition. Testicular DNA damage and repair were assessed by the Comet assay (for DNA damage) and the unscheduled DNA synthesis assay (for DNA repair). 1,3-Butadiene caused a statistically significant increase in dominant lethality at 125 ppm but not 12.5 ppm. No significant increase in DNA repair was found with either dose level or exposure period while only 6 h exposure to 125 ppm caused a small but significant increase in DNA damage as detected by the Comet assay. These effects demonstrate the reproductive genotoxicity of (125 ppm) 1,3-butadiene but do not confirm its ability to cause abnormalities in the offspring via the sperm. It is suggested that the relationship between 1,3-butadiene-induced DNA damage, DNA repair and heritable defects in the offspring may depend on the pattern of metabolites produced.

Animals↗
PubMedDate not supplied

Dyspnea relief.

Explore the source record for details and available documents.

Administration, Inhalation↗
PubMed2001

A physiologically based pharmacokinetic model for inhalation and intravenous administration of naphthalene in rats and mice.

A diffusion limited physiologically based pharmacokinetic model for rats and mice was developed to characterize the absorption, distribution, metabolism, and elimination of naphthalene after inhalation exposure. This model includes compartments for arterial and venous blood, lung, liver, kidney, fat, and other organs. Primary sites for naphthalene metabolism to naphthalene oxide are the lung and the liver. The data used to create this model were generated from National Toxicology Program inhalation and iv studies on naphthalene and consisted of blood time-course data of the parent compound in both rats and mice. To examine the basis for possible interspecies differences in response to naphthalene, the model was extended to describe the distribution and metabolism of naphthalene oxide and the depletion and resynthesis of glutathione. After testing several alternative models, the one presented in this paper shows the best fit to the data with the fewest assumptions possible. The model indicates that tissue dosimetry of the parent compound alone does not explain why this chemical was carcinogenic to the female mouse lung but not to the rat lung. The species difference may be due to a combination of higher levels of naphthalene oxide in the mouse lung and a greater susceptibility of the mouse lung to epoxide-induced carcinogenesis. However, conclusions regarding which metabolite(s) may be responsible for the lung toxicity could not be reached.

Administration, Inhalation↗
PubMedDate not supplied

Viral croup: a current perspective.

Viral croup is the most common cause of upper airway obstruction in children 6 months to 6 years of age. Parainfluenza virus accounts for the majority of cases. The disease is characterized by varying degrees of inspiratory stridor, barking cough, and hoarseness because of laryngeal and/or tracheal obstruction. The diagnosis is mainly a clinical one and diagnostic studies usually are not necessary. The management has altered dramatically in the past decade. Good evidence exists to support the routine use of corticosteroid in all children with croup. Intervention at an earlier phase of the illness will reduce the severity of the symptoms and the rates of return to a health care practitioner for additional medical attention, visits to the emergency department, and admission to the hospital. Most children respond to a single, oral dose of dexamethasone. For those who do not tolerate the oral preparation, nebulized budesonide or intramuscular dexamethasone are reasonable alternatives. Nebulized epinephrine should be reserved for patients with moderate to severe croup. Simultaneous administration of corticosteroid and epinephrine reduces the rate of intubation in patients with severe croup and impending respiratory failure.

Administration, Inhalation↗
PubMed2001

Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years.

BACKGROUND: The greatest prevalence of asthma is in preschool children; however, the clinical utility of asthma therapy for this age group is limited by a narrow therapeutic index, long-term tolerability, and frequency and/or difficulty of administration. Inhaled corticosteroids and inhaled cromolyn are the most commonly prescribed controller therapies for young children with persistent asthma, although very young patients may have difficulty using inhalers, and dose delivery can be variable. Moreover, reduced compliance with inhaled therapy relative to orally administered therapy has been reported. One potential advantage of montelukast is the ease of administering a once-daily chewable tablet; additionally, no tachyphylaxis or change in the safety profile has been evidenced after up to 140 and 80 weeks of montelukast therapy in adults and pediatric patients aged 6 to 14 years, respectively. To our knowledge, this represents the first large, multicenter study to address the effects of a leukotriene receptor antagonist in children younger than 5 years of age with persistent asthma, as well as one of the few asthma studies that incorporated end points validated for use in preschool children. OBJECTIVE: Our primary objective was to determine the safety profile of montelukast, an oral leukotriene receptor antagonist, in preschool children with persistent asthma. Secondarily, the effect of montelukast on exploratory measures of asthma control was also studied. DESIGN AND STATISTICAL ANALYSIS: We conducted a double-blind, multicenter, multinational study at 93 centers worldwide: including 56 in the United States, and 21 in countries in Africa, Australia, Europe, North America, and South America. In this study, we randomly assigned 689 patients (aged 2-5 years) to 12 weeks of treatment with placebo (228 patients) or 4 mg of montelukast as a chewable tablet (461 patients) after a 2-week placebo baseline period. Patients had a history of physician-diagnosed asthma requiring use of beta-agonist and a predefined level of daytime asthma symptoms. Caregivers answered questions twice daily on a validated, asthma-specific diary card and, at specified times during the study, completed a validated asthma-specific quality-of-life questionnaire. Physicians and caregivers completed a global evaluation of asthma control at the end of the study. Efficacy end points included: daytime and overnight asthma symptoms, daily use of beta-agonist, days without asthma, frequency of asthma attacks, number of patients discontinued because of asthma, need for rescue medication, physician and caregiver global evaluations of change, asthma-specific caregiver quality of life, and peripheral blood eosinophil counts. Although exploratory, the efficacy end points were predefined and their analyses were written in a data analysis plan before study unblinding. At screening and at study completion, a complete physical examination was performed. Routine laboratory tests were drawn at screening and weeks 6 and 12, and submitted to a central laboratory for analysis. Adverse effects were collected from caregivers at each clinic visit. An intention-to-treat approach, including all patients with a baseline measurement and at least 1 postrandomization measurement, was performed for all efficacy end points. An analysis-of-variance model with terms for treatment, study center and stratum (inhaled/nebulized corticosteroid use, cromolyn use, or none) was used to estimate treatment group means and between-group differences and to construct 95% confidence intervals. Treatment-by-age, -sex, -race, -radioallergosorbent test, -stratum, and -study center interactions were evaluated by including each term separately. Fisher's exact test was used for between-group comparisons of the frequency of asthma attacks, discontinuations from the study because of worsening asthma, need for rescue medication, and the frequencies of adverse effects. Because of an imbalance in baseline values for eosinophil counts for the 2 treatment groups, an analysis of covariance was performed on the eosinophil change from baseline with the patient's baseline as covariate. STUDY PARTICIPANTS: Of the 689 patients enrolled, approximately 60% were boys and 60% were white. Patients were relatively evenly divided by age: 21%, 24%, 30%, and 23% were aged 2, 3, 4, and 5 years, respectively. For 77% of the patients, asthma symptoms first developed during the first 3 years of life. During the placebo baseline period, patients had asthma symptoms on 6.1 days/week and used beta-agonist on 6.0 days/week. RESULTS: In over 12 weeks of treatment of patients aged 2 to 5 years, montelukast administered as a 4-mg chewable tablet produced significant improvements compared with placebo in multiple parameters of asthma control including: daytime asthma symptoms (cough, wheeze, trouble breathing, and activity limitation); overnight asthma symptoms (cough); the percentage of days with asthma symptoms; the percentage of days without asthma; the need for beta-agonist or oral corticosteroids; physician global evaluations; and peripheral blood eosinophils. The clinical benefit of montelukast was evident within 1 day of starting therapy. Improvements in asthma control were consistent across age, sex, race, and study center, and whether or not patients had a positive radioallergosorbent test. Montelukast demonstrated a consistent effect regardless of concomitant use of inhaled/nebulized corticosteroid or cromolyn therapy. Caregiver global evaluations, the percentage of patients experiencing asthma attacks, and improvements in quality-of-life scores favored montelukast, but were not significantly different from placebo. There were no clinically meaningful differences between treatment groups in overall frequency of adverse effects or of individual adverse effects, with the exception of asthma, which occurred significantly more frequently in the placebo group. There were no significant differences between treatment groups in the frequency of laboratory adverse effects or in the frequency of elevated serum transaminase levels. Approximately 90% of the patients completed the study. CONCLUSIONS: Oral montelukast (4-mg chewable tablet) administered once daily is effective therapy for asthma in children aged 2 to 5 years and is generally well tolerated without clinically important adverse effects. Similarly, in adults and children aged 6 to 14 years, montelukast improves multiple parameters of asthma control. Thus, this study confirms and extends the benefit of montelukast to younger children with persistent asthma.

Acetates↗
PubMed1997

Ragweed allergic rhinitis and the paranasal sinuses. A computed tomographic study.

OBJECTIVE: To explore the potential association of allergic rhinitis and sinusitis. DESIGN: Prospective clinical trial. SETTING: Academic tertiary referral center. PARTICIPANTS: Ten subjects with symptomatic ragweed allergy during the peak of the ragweed season. MAIN OUTCOME MEASURES: We obtained a paranasal sinus computed tomographic scan on all volunteers and had them complete a modified Rhinitis Quality of Life Questionnaire. All subjects were then treated with intranasal aqueous beclomethasone dipropionate (168 micrograms twice a day) and completed the Rhinitis Quality of Life Questionnaire weekly until the end of the study. RESULTS: Six of 10 of the subjects had sinus mucosal thickening on computed tomographic scan. All subjects improved symptomatically. A second computed tomographic scan was obtained after the pollen season in 5 patients with mucosal abnormalities, while the patients continued treatment with intranasal steroids and symptomatically improved. The sinus mucosal abnormalities persisted in all patients. CONCLUSION: Despite the 60% incidence of abnormalities on the computed tomographic scans of the subjects with ragweed allergy during the season, these abnormalities appear, at most, to contribute minimally to the patient's symptoms, since resolution of symptoms was not accompanied by a reduction in sinus mucosal abnormalities.

Administration, Inhalation↗
PubMed1997

Glucocorticoid treatment for nasal polyps. The use of topical budesonide powder, intramuscular betamethasone, and surgical treatment.

BACKGROUND: The treatment of nasal polyps is controversial, and medical treatment alone has been little investigated to our knowledge. OBJECTIVE: To examine the efficacy of therapy using only topical budesonide powder and topical budesonide powder supplemented with surgical removal or intramuscular betamethasone. DESIGN: Randomized, double-blind comparison of 2 dosages and additional treatment, if therapy failed. After 1 year, treatment with medication was stopped, and the demand for renewed treatment was monitored for another year. PATIENTS: Patients with bilateral nasal polyps who demanded treatment were consecutively enrolled in a hospital outpatient clinic or specialty private practice. During a 15-month period from 1990 to 1992, a total of 126 patients entered the 2-year study. INTERVENTIONS: In phase 1, randomized and double-blind treatment with a topical medication, budesonide powder, 800 micrograms or 400 micrograms daily, or a placebo was given for 1 month. In phase 2, randomized and double-blind treatment with budesonide powder, 800 micrograms or 400 micrograms daily, was given. At the end of phase 1, failed therapy was supplemented by randomly assigned treatment of either surgical removal or a single injection of sustained released betamethasone. In phase 3, treatment with the medication was discontinued, and patients were monitored for another year. The time when treatment was required again was noted. The present article deals with phases 2 and 3. MAIN OUTCOME MEASURES: Patients' scores of treatment efficacy as well as symptoms and signs. Semiquantitative measurement of sense of smell and calculation of peak expiratory flow rate index based on nasal and oral peak expiratory flow. RESULTS: In all outcome measures, a comparison of the data before treatment with the corresponding figures during phase 2 showed statistically significant efficacy. The clinical course was described at the end of phase 2. About 85% of the patients, including those who received additional therapy because the initial therapy failed, rated total or substantial control over the symptoms. The 2 dosages investigated showed equal results. These findings were consistent with the signs recorded and the peak expiratory flow rate index. The results of phase 3 showed that 50% of patients had demanded treatment after 4 months, while 34% managed without medication after 1 year. CONCLUSIONS: The clinical course in this study showed that most patients with nasal polyps do well with medical treatment. Therefore, surgery was required in few patients. However, the potential of medical treatment should be further explored in future studies.

Administration, Inhalation↗
PubMed2001

Effectiveness of oral or nebulized dexamethasone for children with mild croup.

OBJECTIVE: To assess the efficacy of oral dexamethasone or nebulized dexamethasone sodium phosphate in children with mild croup. METHODS: Double-blind, placebo-controlled study of 264 children between 6 months and 6 years of age with symptoms of croup for fewer than 48 hours. Patients were excluded if they received racemic epinephrine or corticosteroid treatment. Other exclusion criteria included corticosteroid treatment during the 14 days prior to enrollment or complicating medical condition. Subjects randomly received oral dexamethasone (0.6 mg/kg), nebulized dexamethasone sodium phosphate (160 microg), or placebo. Telephone follow-up was obtained on days 1, 2, 3, 4, and 7. MAIN OUTCOME MEASURES: The primary outcome measure was treatment failure, defined as receiving corticosteroid or racemic epinephrine treatment during the 7 days after enrollment in the study. Secondary outcome measures included seeking additional care and the parental assessments of the patients' condition obtained during follow-up (worse, same, better, or gone). RESULTS: Eighty-five patients received oral dexamethasone, 91 received nebulized dexamethasone, and 88 received placebo. There were 3 treatment failures in the oral dexamethasone-treated group, 12 in the nebulized dexamethasone-treated group, and 10 in the placebo-treated group (P =.05). Ten children in the oral dexamethasone-treated group sought additional care compared with 27 and 29 in the nebulized dexamethasone-treated and placebo-treated groups, respectively (P =.002). Parents of children in the oral dexamethasone-treated group reported greater improvement on day 1 (P<.001) compared with the nebulized dexamethasone-treated and placebo-treated groups. CONCLUSIONS: Children with mild croup who receive oral dexamethasone treatment are less likely to seek subsequent medical care and demonstrate more rapid symptom resolution compared with children who receive nebulized dexamethasone or placebo treatment.

Administration, Inhalation↗