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PubMed1988

Effects of the respiratory tract on inhaled materials.

Inhalation exposure is often compared to intravenous or oral routes of administration with regard to the biological fate of inhaled materials. Such comparisons, however, overlook the contribution of respiratory tract enzymes to the metabolic fate and toxicity of inhaled materials. The effect of respiratory tract metabolism on the toxicity of inhaled materials is thought to be substantial for many compounds for the following reasons. (1) High concentrations of xenobiotic metabolizing enzymes occur in the nose and substantial concentrations occur in the lung. (2) The respiratory tract tissues are the first exposed to inhaled materials and are exposed to the highest concentrations (barring tissue specific uptake). (3) The products of respiratory tract metabolism may have different toxicities from those of hepatic metabolism. (4) Tissues at risk to toxic metabolites formed in the respiratory tract are different from those formed in the liver. These four reasons for concluding that respiratory tract metabolism may influence the toxicity of inhaled materials are backed by a solid body of expanding experimental data. Therefore, a complete assessment of the fate of inhaled materials should include assessment of potential contributions of respiratory tract metabolism.

Administration, Inhalation↗
PubMed1988

The safety of inhaled beta-agonist bronchodilators during pregnancy.

To assess the safety of inhaled beta-agonist bronchodilators during pregnancy, perinatal outcomes in 259 prospectively managed women with asthma using these medications during pregnancy were compared to perinatal outcomes in 101 concurrently followed pregnant subjects with asthma not using inhaled bronchodilators and to perinatal outcomes in 295 concurrently followed pregnant control subjects without asthma. No significant differences between women with asthma using inhaled bronchodilators and subjects not receiving inhaled bronchodilators were found in the following parameters: perinatal mortality, congenital malformations, preterm births, low birth weight infants, mean birth weight, small for gestational age or low ponderal index infants, Apgar scores, labor/delivery complications, or postpartum bleeding. Increased incidences of maternal chronic and pregnancy-induced hypertension and transient tachypnea of the neonate were observed in the pregnancies of subjects with asthma using regular inhaled bronchodilators compared to control subjects, but a logistic regression analysis within the sample of subjects with asthma did not significantly associate the use of inhaled bronchodilators with these outcomes. In the light of the known substantial perinatal risks of severe, uncontrolled asthma and the relatively sparse evidence of human gestational safety for alternative asthma medications, these data support the use of inhaled beta-agonist bronchodilators as part of the management of asthma during pregnancy.

Administration, Inhalation↗
PubMed1992

The effect of inhaled salmeterol on methacholine responsiveness in subjects with asthma up to 12 hours.

The duration of the protective effect of 50 and 100 micrograms of inhaled salmeterol against methacholine-induced bronchoconstriction was compared with that of 200 micrograms of inhaled salbutamol in 12 patients with asthma with a baseline FEV1 of at least 70% and a provocative concentration of inhaled methacholine causing a 20% fall in FEV1 (PC20) greater than or equal to 8 mg/ml. The study was placebo controlled, double blind, randomized, and crossover. The bronchodilating effect was no longer significant 4 hours after inhalation of salbutamol, whereas the effect was still present 12 hours after administration of 50 and 100 micrograms of salmeterol. All active treatments caused PC20 to increase at 1 hour (p less than 0.05). PC20 (milligrams per milliliter) thus reached 3.7 +/- 0.8 after placebo, 13.8 +/- 3.0 after 50 micrograms of salmeterol, 23.2 +/- 4.7 after 100 micrograms of salmeterol, and 13.9 +/- 3.4 after 200 micrograms of salbutamol. The protective effect of 200 micrograms of salbutamol was no longer significant at 4 hours, whereas both doses of salmeterol protected against methacholine challenge up to 12 hours after inhalation (p less than 0.01). An increased incidence of tremor (2/12) and palpitations (2/12) was recorded after inhalation of 100 micrograms of salmeterol. We conclude that inhalation of 50 or 100 micrograms of salmeterol causes a long-lasting bronchodilatation and protects against methacholine-induced bronchoconstriction for at least 12 hours.

Administration, Inhalation↗
PubMed1993

Duration of preventive effect of inhaled salbutamol on early airway response to allergen in asthmatic subjects.

Salbutamol is known to effectively prevent early asthmatic response (EAR) after specific bronchial provocation test (sBPT) in asthmatic subjects, but the time-course of this protection is not known. In this study the effects of 200 micrograms salbutamol inhaled 2 h before sBPT were compared with 200 micrograms salbutamol inhaled 10 min before sBPT in eight asthmatic subjects sensitized to Phleum pratensis (PP) or Dermatophagoides pteronyssinus (DP). All subjects showed an EAR (% decrease in FEV1 from baseline value: 30.4 +/- 11%) in a preliminary sBPT performed with cumulated doses of extracts of PP or DP titrated in biological units (BU). Each subject performed, on two different days, in a random, double-blind, cross-over study, two puffs of placebo 2 h before sBPT and two puffs of salbutamol 10 min before sBPT (treatment A) or two puffs of salbutamol 2 h before sBPT and two puffs of placebo 10 min before sBPT (treatment B). Baseline FEV1 were similar in both tests. In treatment B, 10 min, 1 h and 2 h after salbutamol inhalation, FEV1 increased significantly with respect to placebo inhalation in treatment A. Ten minutes after salbutamol inhalation in treatment A, FEV1 became similar to that obtained 2 h after salbutamol inhalation and 10 min after placebo in treatment B. Allergen inhalation induced an EAR in only one out of eight subjects after treatment A, and five of the eight subjects after treatment B.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗
PubMed1995

Salbutamol powder inhaled from the Diskhaler compared to salbutamol as nebulizer solution in severe chronic airways obstruction.

The bronchodilatory effect of four doses of salbutamol powder (1.6 mg) from a multi-dose dry powder inhaler, the Diskhaler, was compared to the effect of 2.5 ml salbutamol nebulizer solution (1 mg ml-1) from a jet nebulizer, Pari Inhalierboy, in a randomized, double-blind, double-dummy, cross-over study performed on 2 consecutive days. Thirty-two patients with severe chronic obstructive pulmonary disease (COPD), a mean FEV1 = 29% of predicted value, and at least a 15% increase in FEV1 after inhaling 5 mg nebulized terbutaline were included. Twenty-eight patients were evaluated: 17 women and 11 men with a mean age of 67 years (range 53-82 years). The mean increases in FEV1 were greater after inhalation via the Diskhaler, although there was no difference in the patients' subjective assessment of the treatments. The powder inhaler was also effective in patients with the lowest baseline FEV1 and the lowest inspiratory peak flow through the inhaler. The study demonstrates that dry powder inhalation of salbutamol via a Diskhaler is at least as effective as inhalation of salbutamol via a jet nebulizer in providing bronchodilation in patients with severe COPD.

Administration, Inhalation↗
PubMed2006

Efficacy and tolerability of fluticasone propionate/salmeterol administered twice daily via hydrofluoroalkane 134a metered-dose inhaler in adolescent and adult patients with persistent asthma: a randomized, double-blind, placebo-controlled, 12-week study.

OBJECTIVE: This study compared the efficacy and tolerability of the combination of fluticasone propionate (FP) and salmeterol (SAL) delivered via a single hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) with those of its 2 components alone delivered via a chlorofluorocarbon (CFC) MDI and placebo (PLA) delivered via HFA MDI in adolescent and adult patients with persistent asthma that was not controlled by medium doses (equivalent to FP 440-660 microg/d) of inhaled corticosteroids (ICSs). METHODS: This was a randomized, double-blind,placebo-controlled, parallel-group study consisting of a 2-week, single-blind, placebo run-in period followed by a 12-week, double-blind treatment period. Participants had to be > or =12 years of age and have a diagnosis of asthma requiring pharmacotherapy for at least 6 months before the study. Patients had to have used ICS therapy for > or =3 months before the study and at a consistent dose for the previous month. Lack of asthma control was defined as a forced expiratory volume in 1 second (FEV(1)) that was 40% to 85% of the predicted value. Patients could not enter the double-blind treatment period if they had 3 days when they required >12 puffs of rescue albuterol per day or >3 nighttime awakenings due to asthma that required treatment with albuterol during the 7 days before the randomization visit. Patients were randomized to receive one of the following treatments delivered via MDI twice daily for 12 weeks: FSC 220/42 microg HFA (2 inhalations of FSC 110/21 microg; 125 microg/21 microg ex-valve); FP 220 microg CFC (2 inhalations of FP 110 microg); SAL 42 microg CFC (2 inhalations of 21 microg); or 2 inhalations of PLA HFA. The primary efficacy end point for FSC versus FP was the mean area under the 12-hour serial FEV(1) curve relative to the prerandomization baseline (FEV(1) AUC(bl)). The primary efficacy end points for FSC versus SAL were the mean change from baseline in morning predose FEV(1) at end point and the probability of not being withdrawn from the study due to worsening asthma. Tolerability assessments included electrocardiograms, routine clinical laboratory tests, vital signs, oropharyngeal examinations, and physical examinations. Adverse events were assessed at each clinic visit. RESULTS: Thirty-two adolescent and 333 adult patients were randomly assigned to receive double-blind treatment. The treatment groups were comparable at baseline with respect to demographic characteristics (mean age, 38-41 years; white race, 78%-88%) and pulmonary function (mean percent predicted FEV(1), 68%-69%; mean asthma symptom score, 1.6 [scale 0-5]; and mean daily albuterol use, 3.1 puffs). After 12 weeks of treatment, the mean FEV(1) AUC(bl) was significantly greater in patients who received FSC compared with those who received FP, SAL, or PLA (7.0, 3.6, 5.3, and 1.4 L-h, respectively; all comparisons, P < or = 0.020). At end point, the mean change from baseline in morning predose FEV(1) for FSC was significantly greater than that for FP, SAL, and PLA (0.41, 0.19, 0.15, and -0.12 L; all comparisons, P < or = 0.001). During 12 weeks of treatment, 7% of patients receiving FSC were withdrawn due to worsening asthma, compared with 24% of patients receiving SAL and 54% of patients receiving PLA (P < 0.001); 11% of patients receiving FP were withdrawn due to worsening asthma. Treatment with FSC resulted in significant improvements in morning and evening peak expiratory flow compared with FP, SAL, and PLA (both, P < 0.001); need for rescue albuterol compared with FP and PLA (P < or =0.005); and asthma symptom scores compared with PLA (P < 0.001). The tolerability of FSC was similar to that of FP or SAL alone. The incidence of possibly drug-related adverse events was generally similar across treatment groups, and the most common (occurring in > or= 2% of patients) were headache (1%-4%), throat irritation (1%-2%), candidiasis of the mouth/throat (0%-2%), unspecified oropharyngeal plaques (0%-2%), and palpitations (0%-2%). CONCLUSIONS: In these adolescent and adult patients whose asthma was not controlled by medium doses of an ICS, FSC delivered via HFA 134a MDI (2 inhalations of 110/21-microg strength administered BID) was more effective in improving lung function than FP or SAL monotherapy or PLA. All treatments were well tolerated.

Adolescent↗
PubMed2004

Inhaled isobutyl nitrite inhibited macrophage inducible nitric oxide by blocking NFkappaB signaling and promoting degradation of inducible nitric oxide synthase-2.

We previously reported that inhaled isobutyl nitrite inhibited macrophage tumoricidal activity by inhibiting inducible nitric oxide (NO) production. In the present study, a much shorter inhalant exposure regimen (five daily exposures) inhibited inducible NO and the NO synthase (NOS2). One of the ways in which NO and NOS2 are regulated is by ubiquitin-dependent NOS2 degradation. Immunoprecipitated NOS2 showed increased poly-ubiquitination, following exposure to the inhalant. In addition, Western blots of macrophage nuclear extracts for the NFkappaB subunit, p65, showed that exposure to the inhalant inhibited NFkappaB signaling, necessary for induction of NOS2. The inhalant blocked phosphorylation of the NFkappaB inhibitor, IkappaBalpha. The inhibition of NFkappaB signaling following inhalant exposure was confirmed using mice transgenic for the kappaB-dependent promoter of the HIV 5' LTR linked to luciferase. The data suggested that inhalant exposure likely inhibited macrophage NO production by blocking NFkappaB-mediated activation signaling and promoting poly ubiquitination of NOS2.

Administration, Inhalation↗
PubMed2006

Dry powder inhalation of colistin in cystic fibrosis patients: a single dose pilot study.

BACKGROUND: Dry powder inhalation (DPI) may be an alternative to nebulisation of drugs in the treatment of chest infections in cystic fibrosis (CF) patients. In a pilot study the feasibility of a colistin dry powder inhaler (prototype Twincer) by a single dose in CF-patients was assessed and compared to nebulised colistin. METHODS: Ten CF-patients, chronically infected with P. aeruginosa, participated in a randomised cross over study. On two visits to the outpatient clinic, patients inhaled colistin sulphomethate as 25 mg dry powder (Twincer) or as 158 mg nebulised solution (Ventstream nebuliser, PortaNeb compressor). Pulmonary function tests were performed before, 5 and 30 min after inhalation. Serum samples were drawn prior to each dose and at 15, 45 min, 1.5; 2.5; 3.5 and 5.5 h after inhalation. RESULTS: The DPI was well tolerated by the patients: no significant reduction in FEV1 was observed. Relative bioavailability of DPI to nebulisation was approx. 140% based on actual dose and approx. 270% based on drug dose label claim. CONCLUSIONS: The colistin DPI (Twincer inhaler) is well tolerated and appreciated by CF-patients. Optimisation with respect to particle size and internal resistance of the inhaler is necessary to attain equivalent pulmonary deposition to liquid nebulisation.

Administration, Inhalation↗
PubMed2004

Adjustable and fixed dosing with budesonide/ formoterol via a single inhaler in asthma patients: the ASSURE study.

Patient-guided management of asthma using adjustable dosing of budesonide/formoterol in a single inhaler (Symbicort) was compared with fixed dosing in an open-label, multicentre, randomised study. Patients, uncontrolled on an inhaled corticosteroid (ICS) or controlled on an ICS and a long-acting beta2-agonist, entered a 4-week run-in period and received budesonide/formoterol (80/4.5 or 160/4.5 microg), 2 inhalations b.i.d. Following randomisation, the fixed-dosing group (n = 764) continued this regimen for a further 12 weeks. The adjustable-dosing group (n = 775) could step down to 1 inhalation b.i.d. if symptoms were controlled, and, at early signs of worsening symptoms, promptly step up to 4 inhalations b.i.d. for < or = 2 weeks. During run-in, National Heart, Lung and Blood Institute symptom-severity grading was maintained in 60% and improved in 31% of patients, clinic peak flow increased from 400 to 4191/min (P<0.001), and health-related quality of life (overall MiniAQLQ) improved from 4.6 to 5.4 (P<0.001). Patients effectively used the adjustable-dosing regimen; 79% reduced budesonide/formoterol dosage and, compared with fixed dosing, the number of inhalations were significantly lowered (3.2 vs. 3.8 inhalations/day, P<0.05). Both regimens were well tolerated. In both groups, symptom control was maintained or improved in 85-86% of patients, and 94% experienced no treatment failures. Consistent with current guidelines, adjustable maintenance dosing with budesonide/formoterol in a single inhaler provides effective asthma control at reduced medication doses.

Administration, Inhalation↗
PubMed2004

A simple pharmacokinetic method to evaluate the pulmonary dose in clinical practice--analyses of inhaled sodium cromoglycate.

When the expected effect of an inhaled drug is not achieved, the cause could be poor inhalation technique and consequently a low pulmonary dose. A simple in vivo test to evaluate the pulmonary dose would be a benefit. This study evaluates the relative and systemic bioavailability following inhalation of nebulized sodium cromoglycate (SCG) in healthy subjects. Blood samples were collected during 240 min and urine was collected in two portions, up to 6 h post-inhalation. Two exposures were performed and comparisons based on the quantification of drug in plasma and urine by a high-performance liquid chromatography (HPLC) procedure were done. In one of the exposures, a pulmonary function test was performed to study if an expected effect of increased absorption could be detected. There was a good correlation between the two exposures shown in the plasma concentrations, but not in the urine analyses. The forced exhaled volume manoeuvres were associated with a higher Cmax and plasma concentrations up to 60 min post-inhalation (P<0.01). This effect was not detected in the urine analyses. We conclude that this pharmacokinetic method with inhaled SCG and plasma analyses could be used to evaluate individual inhalation technique. The HPLC method used was rapid and had adequate sensitivity.

Administration, Inhalation↗
PubMed2004

Effect of inhalation of thermal water on airway inflammation in chronic obstructive pulmonary disease.

Thermal water inhalations have been traditionally used in the treatment of upper and lower chronic airway diseases. However, the benefit and the mechanism of this treatment have not been properly assessed. To determine whether inhaled salt-bromide-iodine thermal water improves lung function, quality of life and airway inflammation, 39 patients with chronic obstructive pulmonary disease (COPD) were randomly assigned to receive 2-weeks inhalation treatment with thermal water (active, no. = 20) or normal saline (control, no. = 19) in single blind. Lung volumes were measured, Saint George's respiratory questionnaire (SGRQ) was administered and induced sputum was performed before and after treatment. No changes in pre- and post-salbutamol lung volumes was observed after inhalation treatment in both groups. SGRQ score showed a significant improvement in active group compared with control group at the end of the trial. The concentration of total cells in induced sputum increased significantly in both active (P < 0.05) and control groups (P < 0.05). Inhalation of thermal water induced a small but significant decrease in percentages of sputum neutrophils (P < 0.01) and a parallel increase in macrophages (P < 0.01). In contrast, normal saline inhalation was not associated with changes in differential sputum cell counts. In conclusion, treatment with inhaled salt-bromide-iodine thermal water in COPD is associated with a reduced proportion of neutrophils in induced sputum suggesting that thermal water may have a mild anti-inflammatory effect on the airways. However, the short-term improvement in some components health-related quality of life was not related with changes in lung function or with the degree of airway inflammation.

Administration, Inhalation↗
PubMed2001

DNA adducts, strand breaks and micronuclei in mice exposed to styrene by inhalation.

Genotoxic and clastogenic effects of styrene were studied in mice. Male NMRI mice were exposed by inhalation to styrene in concentrations of 750 and 1500 mg/m3 for 21, 7, 3 and 1 days (6 h/day, 7 days/week). Followed parameters included styrene in blood, specific styrene oxide (SO) induced DNA adducts, DNA strand breaks and micronuclei. The formation of SO induced 7-SO-guanines and 1-SO-adenines in DNA was analysed from lung tissues by two versions of the 32P-postlabeling technique. In lungs after 21 days of exposure to 1500 mg/m3 the level of 7-SO-guanine was 23.0+/-11.9 adducts/10(8) normal nucleotides, while 1-SO-adenine was detected at the levels of 0.6+/-0.2 adducts/10(8) normal nucleotides. Both 7-SO-guanines and 1-SO-adenines strongly correlated with exposure parameters, particularly with styrene concentration in blood (r=0.875, P=0.0002 and r=0.793, P=0.002, respectively). DNA breaks were measured in peripheral lymphocytes, bone marrow cells and liver cells using comet assay. To discern oxidative damage and abasic sites, endonuclease III was used. In bone marrow of exposed mice slight increase of strand breaks can be detected after 7 days of inhalation. A significant increase was revealed in the endonuclease III-sensitive sites after 21 days of inhalation in bone marrow. In the liver cells inhalation exposure to both concentrations of styrene did not virtually affect either levels of DNA single-strand breaks or endonuclease III-sensitive sites. The inhalation of 1500 mg/m3 of styrene induced significant increase of micronuclei after 7 days of exposure (10.4+/-2.5/1000 cells, i.e. twice higher micronuclei frequency than in controls). After 21 days of inhalation no significant difference between the control group and the two exposed groups was observed. Whether the decrease of micronuclei after 21 days of inhalation was due to the inhibition of cell proliferation caused by styrene or due to the natural elimination of chromatide fragments, remains to be clarified. An interesting link has been found between DNA single-strand breaks in bone marrow and frequencies of micronuclei (r=0.721, P=0.028).

Administration, Inhalation↗
PubMed1997

Rapid lung cytokine accumulation and neutrophil recruitment after lipopolysaccharide inhalation by cigarette smokers and nonsmokers.

Inhalation of lipopolysaccharide (LPS) by humans rapidly recruits neutrophils to alveolar structures. Recruitment of neutrophils may be mediated in part by intrapulmonary release of cytokines such as tumor necrosis factor-alpha, interleukin (IL)-1beta, and IL-8, although the kinetics of cytokine accumulation and neutrophil recruitment to the lungs after LPS inhalation have not been determined. Release of some cytokines in response to LPS is reported to be decreased in smokers' alveolar macrophages compared with nonsmokers', suggesting responses to LPS may differ in smokers (S) and nonsmokers (NS). To assess the kinetics of early cytokine accumulation after LPS inhalation and to compare inflammation induced in LPS-exposed S and NS, we performed bronchoalveolar lavage (BAL) in 28 subjects (14 NS and 14 S) at 90 or 240 minutes after inhalation of aerosolized LPS (30 microg). BAL performed at 90 and 240 minutes after LPS inhalation recovered increased numbers of neutrophils and lymphocytes in both NS and S compared with an unexposed control group (10 NS, 10 S), with greater recovery of neutrophils in S than NS (p < 0.001). BAL fluid supernate concentrations of IL-8, IL-1beta, and tumor necrosis factor-alpha at 90 minutes were increased in S and NS compared with an unexposed control group. IL-8 and tumor necrosis factor-alpha concentrations were similar in S and NS; however, IL-1beta concentrations were greater in S (p < 0.005). BAL fluid concentrations of IL-1beta and IL-8 at 90 minutes correlated with absolute neutrophil recovery in S and NS. These findings suggest that the rapid accumulation of cytokines, particularly IL-1beta and IL-8, contributes to lung neutrophil recruitment after LPS inhalation. In addition, parameters of pulmonary inflammation present in S after LPS inhalation are similar to or increased compared with those present in NS.

Administration, Inhalation↗
PubMed1991

Physiological pharmacokinetic modeling of inhaled trichloroethylene in rats.

The pharmacokinetics of trichloroethylene (TCE) was characterized during and following inhalation exposures of male Sprague-Dawley rats. The blood and exhaled breath TCE time-course data were used to formulate and assess the accuracy of predictions of a physiologically based pharmacokinetic (PB-PK) model for TCE inhalation. Fifty or 500 ppm of TCE was inhaled by unanesthetized rats of 325-375 g for 2 hr through a miniaturized one-way breathing valve. Repetitive samples of the inhaled and exhaled breath streams, as well as arterial blood, were collected concurrently during and for 3 hr following the exposures and analyzed for TCE by headspace gas chromatography. Respiratory rates and volumes were continuously monitored and used in conjunction with the pharmacokinetic data to delineate uptake and elimination profiles. Levels of TCE in the exhaled breath attained near steady-state soon after the beginning of exposures, and were then directly proportional to the inhaled concentration. Exhaled breath levels of TCE in rats were similar in magnitude to values previously published for TCE inhalation exposures of humans. Levels of TCE in the blood of the 50 ppm-exposed animals also rapidly approached near steady-state, but blood levels in the 500 ppm-exposed animals rose progressively, reaching concentrations 25- to 30-fold higher than in the 50 ppm group during the second hour of exposure. The 10-fold increase in inhaled concentration resulted in an 8.7-fold increase in cumulative uptake, or total absorbed dose. These findings of nonlinearity indicate that metabolic saturation ensued during the 500 ppm exposure. The PB-PK model was characterized as blood flow-limited with TCE eliminated unchanged in the exhaled breath and by saturable liver metabolism. The uptake and elimination profiles were accurately simulated by the PB-PK model for both the 50 and 500 ppm TCE exposure levels. Such a model may be quite useful in risk assessments in predicting internal (i.e., systemically absorbed) doses of TCE and other volatile organics under a variety of exposure scenarios.

Administration, Inhalation↗
PubMed1998

Current issues for establishing inhaled corticosteroids as the antiinflammatory agents of choice in asthma.

Airway inflammation appears to be present even in the mildest of asthma, and inhaled corticosteroids now form the mainstay of asthma therapy. Inhaled corticosteroids largely avoid the adverse effects associated with oral steroids and are now recommended in newly detected disease. Inhaled corticosteroids reduce airway inflammation, airway hyperresponsiveness, and the symptoms of asthma and improve lung function, irrespective of the patient's age or asthma severity. Several different inhaled corticosteroids are available as therapeutic options for the treatment of asthma, and these include fluticasone propionate, beclomethasone dipropionate, and budesonide. The efficacy and safety of inhaled corticosteroids are compared in this article, and inhaled corticosteroid therapy is also compared with other therapies. Recently, there has been a consensus that the optimal use of inhaled corticosteroids for asthma management is using a "start high--go low" approach, and the reasons for this are discussed.

Administration, Inhalation↗
PubMed1998

Effects of inhaled corticosteroids on growth.

Inhaled corticosteroids are an established treatment for asthma in childhood. The risk of adverse events associated with conventional doses of inhaled corticosteroids is low, but in children with asthma concern remains about the potential effects of these compounds on growth. Short-term growth in children can be measured with knemometry. This technique measures changes in lower leg length that can be detected over periods as short as days or even intradaily. However, nonlinearity of lower leg growth and the complexity of statural growth confound any attempts to derive a predicted height from short-term measurements of the lower leg. Knemometry is better at detecting growth suppression than growth promotion. With knemometry, inhaled fluticasone propionate 200 microg/day had no effect on lower leg growth, but beclomethasone propionate 400 microg/day significantly reduced lower leg growth. Inhaled budesonide also caused a dose-dependent reduction in lower leg growth, but this only reached significance at the 800 microg/day dose. Long-term growth in children is measured with stadiometry. Growth velocity can only be determined from measurements of height taken over a period of at least 1 year. There is no evidence that inhaled corticosteroids at conventional doses have an adverse effect on the final height of children, but it is important to be aware of the growth-impairing effect of poorly controlled asthma. All children with asthma receiving inhaled corticosteroids should have their growth monitored, and any deviation from the expected pattern should be investigated. The effect of early intervention with inhaled steroids in childhood warrants further investigation.

Administration, Inhalation↗
PubMed1998

Efficacy of inhaled corticosteroids in asthma.

Inhaled corticosteroids have now become established as first-line therapy for patients with persistent asthma. Corticosteroids are the only currently available asthma therapy that suppress inflammation in asthmatic airways, and they inhibit almost every aspect of the inflammatory process in asthma. Inhaled corticosteroids are effective in most patients with asthma, irrespective of age or asthma severity. They not only control asthma symptoms and improve lung function but also prevent exacerbations and may reduce asthma mortality and the irreversible changes in airway function that occur in some patients. The dose-response curve to inhaled corticosteroids is relatively flat, and there is increasing evidence that addition of another class of therapy (long-acting inhaled beta2-agonists, low-dose theophylline, or antileukotrienes) may be preferable to increasing the dose of inhaled corticosteroids in patients with moderate-to-severe asthma. Inhaled corticosteroids are convenient to use and are the most cost-effective treatment currently available for long-term asthma control. A small proportion of patients are resistant to the antiinflammatory effects of corticosteroids. Future developments may include inhaled corticosteroids with even fewer systemic effects or more specific antiinflammatory drugs.

Administration, Inhalation↗
PubMed1999

Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma.

BACKGROUND: Salmeterol, a long-acting beta2 -agonist, and zafirlukast, a leukotriene receptor antagonist, are both indicated for the treatment of asthma in adolescent and adult patients. OBJECTIVE: We sought to compare the effect of 4 weeks of treatment with inhaled salmeterol xinafoate versus oral zafirlukast in the treatment of persistent asthma. METHODS: This was a randomized, double-blind, double-dummy, parallel-group, multicenter clinical trial. Patients, over 80% of whom were on a concurrent inhaled corticosteroid regimen, were treated for 4 weeks with either inhaled salmeterol xinafoate 42 microgram twice daily administered by means of a metered-dose inhaler or oral zafirlukast 20 mg twice daily. The primary efficacy measure was morning peak expiratory flow (PEF); secondary efficacy measures included evening PEF, asthma symptom scores, supplemental albuterol use, nighttime awakenings, sleep symptoms, asthma exacerbations, and FEV1. RESULTS: Both inhaled salmeterol and oral zafirlukast resulted in within-group improvements from baseline in measures of pulmonary function, asthma symptoms, and supplemental albuterol use. Salmeterol treatment resulted in significantly greater improvements from baseline compared with zafirlukast for most efficacy measurements, including morning PEF (29.6 vs 13.0 L/min; P </= .001), percentage of symptom-free days (22.4% vs 8.8%; P </= .001), and percentage of days and nights with no supplemental albuterol use (30.5% vs 11.3%; P </= .001). There were no differences in safety profiles as assessed by adverse event monitoring. CONCLUSION: In patients with persistent asthma, most of whom were concurrently using inhaled corticosteroids, treatment with inhaled salmeterol provided significantly greater improvement than oral zafirlukast in overall asthma control over the 4-week treatment period.

Administration, Inhalation↗