HOW TO EVALUATE YOUR INHALATION THERAPY PROGRAM.
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Administration, Inhalation↗
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Inhaled vs oral steroids for adults with chronic asthma.
OBJECTIVES: To determine therapeutically equivalent doses of inhaled versus oral steroids for adults with chronic asthma. SEARCH STRATEGY: The Cochrane Airways Group trials register was searched using the terms: (drug delivery systems OR ((nebuli* OR inhal* OR MDI) AND oral*)) AND ( steroid* OR corticosteroid* OR glucocorticoid* OR beclomethasone OR betamethasone OR fluticasone OR cortisone OR dexamethasone OR hydrocortisone OR prednisolone OR prednisone OR triamcinolone). SELECTION CRITERIA: Randomised controlled trials were selected of at least 4 weeks duration and included patients over the age of 15 years with chronic asthma. Trials compared inhaled steroids and oral prednisolone or prednisone; where the maximum dose for inhaled steroids was 2000 mcg/day and prednisolone 60 mg (on alternate days). DATA COLLECTION AND ANALYSIS: Two independent reviewers screened 1285 titles and abstracts from the electronic search, bibliography searches and other contacts. Of these, 10 trials met previously defined inclusion criteria. Two reviewers independently extracted study characteristics, and outcome measures. MAIN RESULTS: All trials were small and no data could be pooled. Carry-over effects were present in at least one cross-over trial. Data from six trials produced the same pattern, in which prednisolone 7.5-12 mg/day appeared to be as effective as inhaled steroid 300-2000 mcg/day. In two trials, inhaled steroid 300-400 mcg/day was more effective than prednisolone 5 mg/day. All doses of inhaled steroid appeared to be more effective than alternate day doses of prednisolone up to 60 mg on alternate days. Side-effect data were reported too variably to permit comparisons. A 30% incidence was reported in one study in patients receiving prednisolone 5 mg/day, none were reported in patients on inhaled steroids. REVIEWER'S CONCLUSIONS: A daily dose of prednisolone 7.5-10 mg/day appears to be equivalent to moderate-high dose inhaled corticosteroids. Side-effects may be present on low doses, so if there is no alternative to oral steroids, the lowest effective dose should be prescribed.
Administration, Inhalation↗
Relative potency of chemical carcinogens in rodents.
Extensive carcinogenesis data compiled by Gold et al. for 770 compounds tested in 2944 chronic bioassays in animals provided an opportunity to compare cancer rates across animal species for a wide variety of compounds administered by various routes of exposure. The comparisons in this paper are restricted to the most frequently tested species: rats, mice, and hamsters. When sufficient experimental data exist, Gold et al. provide estimates of the TD50 (the chronic dose rate expressed in mg/kg body weight/day which halves the actuarially adjusted percentage of tumor-free animals at the end of a standard lifetime experiment). Since the current practice generally is to base risk assessments upon the data set producing the highest cancer risk, the ratio of the minimum TD50's provides a measure of the relative potency between two species for each compound administered to animals by the same route. The geometric means of the ratios of minimum TD50's for rats:mice are 1/2.2 and 1/1.3 for diet and gavage, respectively. A mean ratio for rats: mice of 1/1.48 is obtained for compounds administered in the diet when the tumor site is the liver for both species. In general the minimum TD50 is lowest for the rat and highest for the hamster. Although limited data are available for inhalation studies, this route of administration resulted in the poorest agreement between rats and mice. In general, comparisons of minimum TD50's across the three rodent species are generally within a factor of 100 for a wide variety of compounds.
Administration, Inhalation↗
Detection of IgE antibodies specific to isonicotinic acid hydrazide and its metabolite by enzyme-linked immunosorbent assay and the mechanism of sensitization by inhalation or ingestion of this compound.
A female hospital pharmacist and a nurse developed occupational asthma due to the inhalation of isonicotinic acid hydrazide (INH) powder. The mechanism of sensitization was examined in this study. Furthermore, IgE antibodies specific to INH and isonicotinic acid (INA), the major metabolite of INH, were examined by means of enzyme-linked immunosorbent assay (ELISA). IgE anti-INH antibody activity was detected by ELISA in sera from 5 out of 8 hospital workers who inhaled INH powder during the handling of INH, and in sera from 10 out of 142 tuberculosis patients receiving oral INH. IgE anti-INA antibody activity was detected in sera from 3 of the 8 hospital workers, and from 7 of the 142 tuberculosis patients. Neither IgE anti-INH nor anti-INA antibody activity was detected in sera from 45 patients with asthma or from 42 healthy volunteers. The specificity of the IgE antibodies and the cross-antigenicity between INH and INA were confirmed by ELISA inhibition studies. Our results indicate that sensitization to INH can occur not only by inhalation but also by oral administration, and that the asthmatic symptoms of the patients were caused by an IgE antibody specific to INH as a hapten.
Administration, Inhalation↗
Hemodynamic and oxygenation changes of combined therapy with inhaled nitric oxide and inhaled aerosolized prostacyclin.
OBJECTIVE: To evaluate hemodynamic and oxygenation changes of combined therapy with inhaled nitric oxide (iNO) and inhaled aerosolized prostcyclin (IAP) during lung transplantation. DESIGN: Prospective study. SETTING: University hospital. PARTICIPANTS: Ten patients scheduled for lung transplantation. INTERVENTIONS: Ten patients, with a mean age of 38 years (range, 24 to 56 years), were scheduled for lung transplantation (2 single-lung transplantations and 8 double-lung transplantations). During first lung implantation with single-lung perfusion and ventilation, hemodynamic and oxygenation data were analyzed in 3 phases: (1) baseline, 5 minutes after pulmonary artery clamping; (2) inhaled NO phase, 15 minutes after inhaled NO administration (20 ppm) in 100% oxygen; and (3) IAP-inhaled NO phase, 15 minutes after combined administration of inhaled NO (20 ppm) and IAP (10 ng/kg/min) in 100% oxygen. MEASUREMENTS AND MAIN RESULTS: During the inhaled NO phase, reductions of mean pulmonary arterial pressure (p < 0.05) and intrapulmonary shunt (p < 0.05) were noted. After the start of prostacyclin inhalation, a further decrease in mean pulmonary arterial pressure (p < 0.05) was observed. PaO2/FIO2 increased during the IAP-inhaled NO phase (p < 0.05), whereas intrapulmonary shunt decreased (p < 0.05). CONCLUSION: This study confirms the action of inhaled NO as a selective pulmonary vasodilator during lung transplantation. Combined therapy with IAP and inhaled NO increases the effects on pulmonary arterial pressure and oxygenation compared with inhaled NO administered alone without any systemic changes.
Administration, Inhalation↗
Optimization of desflurane administration in morbidly obese patients: a comparison with sevoflurane using an 'inhalation bolus' technique.
BACKGROUND: The concept of an 'inhalation bolus' can be used to optimize inhaled drug administration. We investigated the depth of anaesthesia, haemodynamic stability, and recovery time in morbidly obese patients resulting from bispectral index (BIS)-guided sevoflurane or desflurane administration and BIS-triggered inhalation boluses of sevoflurane or desflurane combined with titration of remifentanil. METHODS: Fifty morbidly obese patients undergoing laparoscopic gastroplasty received either BIS-guided sevoflurane or desflurane anaesthesia in combination with a remifentanil target-controlled infusion. Intraoperative haemodynamic stability and BIS control were measured. Immediate recovery was recorded. RESULTS: Intraoperatively, the BIS was between 40 and 60 for a greater percentage of time in the sevoflurane (78 (13)% of case time) than in the desflurane patients (64 (14)% of case time), owing to too profound anaesthesia in the desflurane patients at the start of the procedure. However, fewer episodes of hypotension were found in the desflurane group, without the occurrence of more hypertensive episodes. During immediate recovery, eye opening, extubation, airway maintenance, and orientation occurred sooner in the desflurane group. CONCLUSIONS: Immediate recovery was significantly faster in the desflurane group. Overall hypnotic controllability measured by BIS was less accurate with desflurane. Overall haemodynamic controllability was better when using desflurane. Fewer episodes of hypotension were found in the desflurane group. The use of the inhalation bolus was found to be appropriate in both groups without causing severe haemodynamic side effects. Minimal BIS values were significantly lower after a desflurane bolus.
Adult↗
Inhibition of experimental autoimmune encephalomyelitis by inhalation but not oral administration of the encephalitogenic peptide: influence of MHC binding affinity.
This study explores antigen administration via mucosal surfaces as a potential means of inducing antigen-specific non-responsiveness in experimental autoimmune encephalomyelitis (EAE). In the H-2u mouse model of EAE, the acetylated N-terminal peptide of myelin basic protein represents a dominant T cell epitope which on its own is sufficient to induce disease. Oral administration of the encephalitogenic peptide over a wide range of doses failed to induce oral tolerance to EAE. In marked contrast, a single intranasal dose of this peptide (Ac1-9 or Ac1-11) profoundly inhibited EAE when administered prior to disease induction. We investigated this phenomenon further by using two analogues of Ac1-11 with alanine or tyrosine at position 4 which display higher affinity binding to the I-Au molecule than the original peptide with lysine at this position. There was a positive correlation between the degree of protection from EAE and the affinity of individual peptides for class II MHC. Peptide inhalation inhibited not only EAE induced by subcutaneous injection of the encephalitogenic peptide but also disease induced by a complex mixture of potential auto-antigens such as spinal cord homogenate. Thus, in contrast to oral tolerance, nonresponsiveness by peptide inhalation is inducible with the encephalitogenic peptide in the absence of additional regulatory epitopes. The finding that a single epitope may protect against EAE induced with whole spinal cord homogenate implies, however, that regulatory mechanisms affecting additional potential self-epitopes may play a significant role.
Administration, Inhalation↗
Cilomilast (Ariflo) does not potentiate the cardiovascular effects of inhaled salbutamol.
We investigated the safety and potential pharmacodynamic interactions arising from the co-administration of inhaled beta(2)-agonist salbutamol and cilomilast (Ariflo), a new oral phosphodiesterase 4 inhibitor for the treatment of chronic obstructive pulmonary disease and asthma. This was a randomised, double-blind, placebo-controlled, multiple-dose, three-period crossover study involving non-smoking volunteers between the ages of 18 and 50 years. Volunteers were randomly assigned to receive cilomilast plus nebulised salbutamol, cilomilast plus nebulised placebo or placebo plus nebulised salbutamol. Each volunteer received cilomilast (10 mg twice daily) or placebo for 5 days. On day 5, the morning dose of cilomilast or placebo was followed 1 h later with a single dose of nebulised salbutamol (2.5 mg) or placebo. Primary variables were average change from pre- to 1.5 h post-salbutamol or placebo inhalation in blood pressure, pulse rate, 12-lead ECG and total number of heartbeats measured by 4-h Holter ECG. Thirteen volunteers completed the study. There was no evidence of a clinically important pharmacodynamic interaction between cilomilast and salbutamol in healthy volunteers. Both agents were well tolerated. In conclusion, the pharmacodynamic effects associated with salbutamol inhalation were unaffected by co-administration of cilomilast.
3',5'-Cyclic-AMP Phosphodiesterases↗
Comparison of GH-stimulation by GH-RH(1-29)NH2 and an agmatine29 GH-RH analog, after intravenous, subcutaneous and intranasal administration and after pulmonary inhalation in rats.
Many studies have shown that human GH-RH(1-29)NH2 possesses full intrinsic activity of GH-RH(1-44)NH2 in vitro and in vivo. This investigation was performed to evaluate the efficacy of GH-RH(1-29)NH2 given by different routes of administration in stimulating GH release in rats. In each case GH-RH(1-29)NH2 was administered intravenously, subcutaneously, intranasally and by pulmonary inhalation at two different doses to groups of seven males rats. At a dose of 150 micrograms/kg GH-RH(1-29)NH2, the magnitude of GH response was significantly higher for the pulmonary inhalation group (355 +/- 33.2 ng GH/mL) than for the subcutaneous group (246 +/- 36 ng GH/mL) or for the intranasal group (175 +/- 30 ng GH/mL). The group injected intravenously with GH-RH(1-29)NH2 at a dose of 2.5 micrograms/kg showed the highest response, GH levels reaching 877.2 +/- 115 ng/mL. A similar pattern of responses was obtained for the superactive GH-RH(1-29) agmatine29 analog, MZ-3-149, at doses that were 50 times lower. Our results indicate a high bioavailability of GH-RH(1-29)NH2 or analog MZ-3-149 administered by a convenient pulmonary inhalation route. The GH-releasing effect of GH-RH(1-29)NH2 or analog MZ-3-149 delivered by pulmonary inhalation is superior to subcutaneous and intranasal administration.
Administration, Inhalation↗
T cells number and function in young asthmatic children during 2 years treatment with inhaled budesonide.
Corticosteroids are known to affect the number and function of circulating lymphocytes in humans. The effect of 2 years administration of inhaled budesonide (200 micrograms/day) on the number and function of B and T lymphocytes and T cell subsets was evaluated in 16 young children with severe asthma. The number of T and B cells and T suppressor/cytotoxic cells (CD8 T cell) and T helper/inducer cells (CD4 T cell) before therapy was found to be comparable to the number of cells observed in the healthy control group. Two years administration of inhaled budesonide did not significantly alter the percentage and absolute number of all these cells. The functional activity of T lymphocytes was evaluated by the "local xenogeneic graft versus host reaction" (GVHR). A positive (normal) GVHR was observed in only 5 of the 16 children (31%) in the budesonide group before therapy, compared to 15 of 16 children (94%) in the healthy control group. During the 2 years treatment with inhaled budesonide, the percentage of patients having positive GVHR increased from 31% before therapy to 69% and 77% after 1 and 2 years of therapy (P = 0.05 and 0.02), respectively. The data observed in this study indicate that 2 years administration of inhaled budesonide did not alter the number of B and T lymphocytes and T cell subsets. However, it was associated with improvement in the GVHR function of T cells.
Administration, Inhalation↗
Sterility requirement for aqueous-based drug products for oral inhalation. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is amending its regulations to require that all prescription and over-the-counter (OTC) aqueous-based drug products for oral inhalation be manufactured sterile. This rule applies to aqueous-based oral inhalation drug products in both single-dose and multiple-use primary packaging. Pressurized metered-dose inhalers are not subject to this rule. Based on reports of adverse drug experiences from contaminated nonsterile inhalation drug products and recalls of these products, FDA is taking this action to help ensure the safety and effectiveness of these products.
Administration, Inhalation↗
Dosing inhaled steroids in asthma: is once-a-day administration effective?
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Administration, Inhalation↗
The inhalation of drugs: advantages and problems.
Inhalation is a very old method of drug delivery, and in the 20th century it became a mainstay of respiratory care, known as aerosol therapy. Use of inhaled epinephrine for relief of asthma was reported as early as 1929, in England. An early version of a dry powder inhaler (DPI) was the Aerohalor, used to administer penicillin dust to treat respiratory infections. In the 1950s, the Wright nebulizer was the precursor of the modern hand-held jet-venturi nebulizer. In 1956, the first metered-dose inhaler (MDI) was approved for clinical use, followed by the SpinHaler DPI for cromolyn sodium in 1971. The scientific basis for aerosol therapy developed relatively late, following the 1974 Sugarloaf Conference on the scientific basis of respiratory therapy. Early data on the drug-delivery efficiency of the common aerosol delivery devices (MDI, DPI, and nebulizer) showed lung deposition of approximately 10-15% of the total, nominal dose. Despite problems with low lung deposition with all of the early devices, evidence accumulated that supported the advantages of the inhalation route over other drug-administration routes. Inhaled drugs are localized to the target organ, which generally allows for a lower dose than is necessary with systemic delivery (oral or injection), and thus fewer and less severe adverse effects. The 3 types of aerosol device (MDI, DPI, and nebulizer) can be clinically equivalent. It may be necessary to increase the number of MDI puffs to achieve results equivalent to the larger nominal dose from a nebulizer. Design and lung-deposition improvement of MDIs, DPIs, and nebulizers are exemplified by the new hydrofluoroalkane-propelled MDI formulation of beclomethasone, the metered-dose liquid-spray Respimat, and the DPI system of the Spiros. Differences among aerosol delivery devices create challenges to patient use and caregiver instruction. Potential improvements in aerosol delivery include better standardization of function and patient use, greater reliability, and reduction of drug loss.
Administration, Inhalation↗
Flovent (fluticasone propionate inhalation aerosol)
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Administration, Inhalation↗
Experimental allergic conjunctivitis in inbred guinea pig strains with high respectively low bronchial allergic reactivity.
Inbred guinea pigs selected for high (IMM/S) respectively low (IMM/R) responsiveness to ovalbumin (OA) as measured by induced respiratory anaphylaxis, were investigated for atopic immune responses of their conjunctival mucosa. IMM/S animals sensitized either by inhalation of OA, or by instillation of antigen into the conjunctival sac, developed regularly an acute ocular inflammatory response to topical (conjunctival) challenge with the allergen. A minimum of 1 microgram OA dropped repeatedly into the conjunctival sac was enough for both ocular and systemic sensitization of the animals, but the minimal dose of effective challenge was considerably higher. In IMM/R animals, ocular hypersensitivity was not achieved by inhalation of OA, but after topical administration of the antigen some of the IMM/R strains could be challenged to ocular anaphylactic responses of the same intensity as observed in IMM/S animals. The conjunctivae of both IMM/S and IMM/R animals could be sensitized passively by intraperitoneal injection of guinea pig sera containing homocytotropic antibodies to OA, but topical administration of such sera had no effect.
Administration, Inhalation↗
The problem of dose-response and therapeutic ratio of inhaled steroids.
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Administration, Inhalation↗
Who benefits from inhaled corticosteroids?
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Administration, Inhalation↗
Metabolism of antipyrine and m-xylene in rats after prolonged pretreatment with xylene alone or xylene with ethanol, phenobarbital or 3-methylcholanthrene.
1. The metabolic disposition of antipyrine (AP) and m-xylene (XYL) has been studied in rats pretreated for a prolonged period with XYL, dosed alone or in combination with ethanol, phenobarbital (PB), or 3-methylcholanthrene (MC). 2. XYL inhalation exposure at 300 ppm in air (7 h/day, 4 days/week, for 1 or 4 weeks) did not alter the total 24-h recovery of AP and its major metabolites in urine, but the excretion profile changed compared with controls: 3-hydroxymethylantipyrine (3-HMA) increased (less than or equal to 14%, P less than 0.001), norantipyrine (NORA) (less than or equal to 23%, P less than 0.01) and AP (less than or equal to 53%, P less than 0.01) decreased. 4-Hydroxyantipyrine (4-OHA) was unchanged. 3. Oral dosage of XYL at 800 mg/kg per day (5 days/week, for 12 days) altered the metabolic disposition of AP similarly to inhalation. 4. XYL + ethanol did not alter the xylene-type effect on AP metabolism. This was at variance with the changes following XYL + PB and, to a greater extent, XYL + MC pretreatments: 4-OHA increased (53-74%, P less than 0.01), 3-HMA (11-42%, P less than 0.05) and AP (greater than or equal to 50%, P less than 0.05) decreased. The effect on NORA was less clear. 5. XYL pretreatment accelerated metabolic disposition of its major urinary metabolite, methylhippuric acid (MHA) and formation of thioethers. 6. Thioether excretion in 24 h urine was enhanced about 10-fold after XYL inhalation and 20-fold after oral administration. Only XYL + PB treatment enhanced further the excretion of xylene-derived thioethers (P less than 0.05). 7. Drug-metabolizing activity (phase I and II reactions) in liver, lung and kidney showed that the treatments resulted in marked and differential biochemical alterations. 8. In conclusion, m-xylene enhanced the rate of its own metabolism and induced differential changes on urinary AP metabolite profile depending on the pretreatment.
Administration, Inhalation↗