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PubMed2006

Acute renal failure associated with inhaled tobramycin.

PURPOSE: A case of nephrotoxicity possibly caused by tobramycin inhalation solution is presented. SUMMARY: A 62-year-old Caucasian woman was admitted for treatment of decreased urine output and sepsis secondary to Pseudomonas aeruginosa. Her past medical history was significant for multiple diseases, including chronic renal insufficiency (baseline serum creatinine concentration [SCr] 2 mg/dL). One month postadmission, the patient was diagnosed with health care-associated pneumonia. The patient was initiated on piperacillin-tazobactam and tobramycin 2 mg/kg i.v. She was changed to imipenem-cilastatin with continuation of i.v. tobramycin. A month after discontinuation of her antibiotic regimen, the patient was diagnosed with P. aeruginosa pneumonia. The patient received imipenem-cilastatin, vancomycin, and inhaled tobramycin 300 mg twice daily. At that time, her SCr was 2 mg/dL. Inhaled tobramycin was continued for four weeks, and the patient's SCr steadily rose to a peak of 4.5 mg/dL. During week 1 of treatment, multidrug-resistant P. aeruginosa and methicillin-resistant Staphylococcus aureus were diagnosed. The patient continued to receive i.v. imipenem-cilastatin, vancomycin, and inhaled tobramycin with an SCr of 1.9 mg/dL. However, at the end of week 2, the patient's SCr began to slowly rise (2.3 mg/dL). At week 3, imipenem-cilastatin was discontinued; inhaled tobramycin was continued. The patient's SCr continued to rise (3.2 mg/dL). At week 4, her SCr rose to 4.5 mg/dL, resulting in initiation of hemodialysis and discontinuation of inhaled tobramycin. The patient's SCr never returned to baseline, and renal function was never regained. CONCLUSION: Acute renal failure requiring dialysis occurred in a high-risk patient receiving an extended course of treatment with inhaled tobramycin.

Acute Kidney Injury↗
PubMed1999

Pharmacoscintigraphic evaluation of lung deposition of inhaled zanamivir in healthy volunteers.

OBJECTIVE: The objective of this study was to determine the sites of zanamivir deposition in the respiratory tract and the pharmacokinetics of zanamivir after oral inhalation from the Diskhaler device and from a prototype of a novel breath-activated device. DESIGN: This was a 2-period block-randomised study in which participants inhaled zanamivir from a Diskhaler and/or the prototype device on separate days. STUDY PARTICIPANTS: 13 healthy volunteers (5 men and 8 women) aged 20 to 42 years (mean age 29 years) and weighing 54.0 to 94.0 kg (mean bodyweight 69.2 kg) entered the study. INTERVENTIONS: Participants were given dry powder zanamivir 10 mg formulated with 99mTc from the Diskhaler or the prototype device on separate days. Scintigraphic images of the chest and oropharynx were recorded. Blood samples for determination of serum zanamivir and urine for excretion studies were taken up to 8 hours after drug administration. Safety was evaluated by monitoring lung function tests, adverse events and laboratory parameters. RESULTS: Orally inhaled zanamivir was well tolerated, as demonstrated by lung function tests. A mean of 13.2% (n = 11) of the 10 mg dose from the Diskhaler was deposited in the bronchi and lungs. The deposition pattern varied between individuals, showing a preferentially central deposition pattern in some and a uniform distribution pattern in others. The major deposition site was the oropharynx (mean 77.6%), with a mean of 1.2% deposited on the trachea and a mean of 3.2% retained in the blister. Similar data were obtained with the prototype device. Inhalation of zanamivir gave a broad peak of systemic absorption with mean maximum serum concentrations of approximately 30 to 40 micrograms/L after 1.5 hours. The rate and extent of absorption were similar irrespective of inhalation device. Less than 5% of drug was excreted unchanged in urine within 8 hours of inhalation, confirming the low bioavailability of zanamivir after pulmonary delivery. A significant correlation existed between systemic exposure and peripheral lung deposition. CONCLUSIONS: The local concentrations of zanamivir that result from oral inhalation via the Diskhaler are estimated to be > 10 mumol/L throughout the respiratory tract, well in excess of the concentrations observed to inhibit influenza virus neuraminidases by 50% (0.64 to 7.9 nmol/L). Similar deposition data were obtained with the Diskhaler and the prototype device, which was consequently not developed further. Pharmacoscintigraphy was confirmed as being a reliable technique for measuring zanamivir deposition in the respiratory tract.

Administration, Inhalation↗
PubMed2000

Systemic exposure to fluticasone propionate administered via metered-dose inhaler containing chlorofluorocarbon or hydrofluoroalkane propellant.

OBJECTIVE: The pharmacokinetic profile of a single dose of inhaled fluticasone propionate (FP) administered via a metered-dose inhaler (MDI), containing either a chlorofluorocarbon (CFC) or hydrofluoroalkane (HFA) propellant was investigated in healthy volunteers. METHODS: Two randomised, double-blind, crossover studies were conducted, each in 12 male volunteers. Both studies compared pharmacokinetic data after a single inhaled dose of FP 1000 microg from a MDI containing either CFC (CFC MDI) or HFA (HFA MDI) with a single intravenous dose of FP 250 microg. RESULTS: The maximum plasma FP concentrations after inhalation via the 2 types of MDI were almost identical (0.56 and 0.54 microg/L for CFC MDI and HFA MDI, respectively); bioavailability values of inhaled FP from the 2 MDIs were also similar (geometric mean values: 26.4% via the CFC MDI and 28.6% via the HFA MDI). Inhalation of FP via both MDI formulations produced similar reductions in urinary cortisol excretion over 12 and 24 hours postdose. CONCLUSION: The bioavailability values of FP after inhalation via a CFC MDI and an HFA MDI are similar. The 2 formulations deliver comparable amounts of FP, and systemic exposures to FP from the 2 devices, measured by urinary cortisol excretion, are not significantly different.

Administration, Inhalation↗
PubMed2001

Clinical pharmacokinetics of inhaled budesonide.

The corticosteroid budesonide is a 1:1 racemic mixture of 2 epimers, (22R)- and (22S)-, and is available in 3 different inhaled formulations for the management of asthma: a pressurised metered dose inhaler (pMDI), a dry powder inhaler (DPI) and a solution for nebulised therapy. Inhaled corticosteroids such as budesonide reach the systemic circulation either by direct absorption through the lungs (a route that is much more important than previously recognised) or via gastrointestinal absorption of drug that is inadvertently swallowed. Although the pharmacokinetics of budesonide have been extensively investigated following oral and intravenous administration, relatively few studies have defined the systemic disposition of budesonide after inhalation. Drug deposition in the lungs depends on the inhaler device: 15% of the metered dose of budesonide reached the lung with a pMDI compared with 32% with a breath-actuated DPI. In patients with asthma (n = 38) receiving different doses of budesonide by DPI (Turbuhaler), the pharmacokinetic parameters peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) were dose-dependent after both single dose and repeat dose (3 weeks) administration: time to Cmax (tmax) was short (0.28 to 0.40 hours) and the elimination half-life approximately 3 hours. Both AUC and Cmax were linearly related to budesonide dose. In a small group of healthy male volunteers (n = 9), the pharmacokinetics of budesonide 1,600 microg twice daily via pMDI were assessed on the fifth day of administration. Mean model-independent parameters for (22R)-budesonide were as follows: Cmax 1.8 microg/L, tmax 0.46 hours, elimination half-life 2.3 hours and oral clearance 163 L/h, and there were no enantiomer-specific differences in drug disposition. Budesonide undergoes fatty acid conjugation within the lung, but very limited pharmacokinetic data are available to define the pulmonary absorption characteristics. There is evidence from a population analysis that the pulmonary absorption of budesonide is prolonged and shows wide interindividual variation. Further pharmacokinetic studies are required to define the time-course of budesonide absorption through the lung in specific patient groups, and to investigate the effect of new inhaler devices (especially chlorofluorocarbon-free pMDIs) on the pharmacokinetic profile and systemic drug exposure.

Administration, Inhalation↗
PubMed2004

Insulin disposition in the lung following oral inhalation in humans : a meta-analysis of its pharmacokinetics.

BACKGROUND: Oral inhalation of insulin potentially offers non-invasive treatment and better glycaemic control in diabetes by virtue of its apparently faster absorption into the systemic circulation compared with subcutaneous injection. Nevertheless, the lung kinetics of inhaled insulin in humans have yet to be fully clarified because of the complexity of insulin-glucose (patho)physiology and the difficulty in approximating the inhaled dose. As a result, there remains considerable debate on the mechanisms of absorption and metabolism of insulin in the lung. OBJECTIVES: To develop and apply a physiologically realistic insulin-glucose kinetic model to a meta-analysis of insulin-glucose profiles from well-controlled clinical studies of inhaled insulin published in the literature, and thereby, to derive the kinetic descriptors of insulin in the lung following inhalation through curve fitting. MODEL DEVELOPMENT: The model assumed first-order absorption (k(a,L)) and parallel non-absorptive loss (k(mm,L)), the latter primarily occurring via metabolism and mucociliary clearance in the lung, alongside two systemic compartments. Where necessary, glucose-dependent endogenous pancreatic insulin secretion was also taken into account by using blood glucose data as the second independent variable. RESULTS: Despite the model's simplicity and the use of mean data, 16 insulin-glucose profiles from ten clinical studies were successfully fitted to the model, yielding values for the rate constants k(a,L) and k(mm,L). Whole serum insulin profiles were rate-determined by k(a,L) and k(mm,L) combined, representing 'flip-flop' pharmacokinetics. The best estimate for k(a,L) was found to be 0.020-0.032 h(-1), effectively unchanged across doses (0.3-1.8 IU/kg), formulations (powder vs liquid) and subjects (healthy vs diabetic), suggesting passive diffusive absorption of insulin from the lung. In contrast, the values for k(mm,L) were much larger (0.5-1.6 h(-1)) and decreased with increasing inhaled dose. Therefore, it is likely that dose-dependent saturable lung metabolism controls the value of k(mm,L), alongside mucociliary clearance. As a result, the absolute bioavailability ranged from 1.5% to 4.8%. The modelling analysis also enabled derivation of increased values for both k(a,L) and k(mm,L) as a possible cause of faster absorption for deep inspiratory manoeuvres and increased absorption in smokers, and faster and increased absorption for insulin lispro. CONCLUSIONS: Although some of these results need to be substantiated experimentally, it appears that this modelling analysis has enabled unification of the literature information associated with the kinetics and mechanisms of insulin disposition in the lung following inhalation in humans.

Absorption↗
PubMed1999

Inhaled fluticasone propionate: a review of its therapeutic efficacy at dosages < or = 500 microg/day in adults and adolescents with mild to moderate asthma.

UNLABELLED: Fluticasone propionate is a corticosteroid with comparatively high receptor affinity and topical activity. Inhaled fluticasone propionate < or =500 microg/day provided effective corticosteroid maintenance treatment in patients with mild to moderate asthma in randomised, controlled clinical studies of 4 to 24 weeks in duration. Dosages of 50 to 250 microg twice daily produced consistent improvement in spirometric measures of lung function, reduced the frequency of as-needed beta2-agonist bronchodilator use, asthma symptom scores and night-time wakenings, and prevented asthma exacerbations compared with placebo. Fluticasone propionate < or =250 microg twice daily provided significantly greater improvements in lung function than nedocromil 4 mg 4 times daily, theophylline (5 to 15 mg/L) or zafirlukast 20 mg twice daily. Health-related quality of life improved significantly with fluticasone propionate 88 microg twice daily, but not zafirlukast 20 mg twice daily or placebo. In comparative trials in which fluticasone propionate was given at half the dosage of beclomethasone dipropionate, budesonide or flunisolide, fluticasone propionate < or =250 microg twice daily produced equivalent or greater improvement in spirometric parameters and equivalent reductions in the use of as-needed beta2-agonists than beclomethasone dipropionate, budesonide or flunisolide. Fluticasone propionate 250 microg twice daily was generally more effective than triamcinolone acetonide 200 microg 4 times daily in two 24-week trials. The combination of inhaled fluticasone propionate < or =250 plus salmeterol < or =50 microg twice daily allowed for the use of lower dosages of the inhaled corticosteroid. The incidence of adverse events in patients receiving inhaled fluticasone propionate 50 to 250 microg twice daily was similar to that in beclomethasone dipropionate 168 to 500 microg twice daily and budesonide 100 to 600 microg twice daily recipients and greater than that in recipients of triamcinolone acetonide 200 microg 4 times daily in comparative trials. The incidence of oral candidiasis was < or =8% in patients treated with fluticasone propionate < or =250 microg twice daily or other agents. There was no evidence of clinically significant hypothalamo-pituitary-adrenal (HPA) axis suppression with fluticasone propionate < or =250 microg twice daily in comparative trials. CONCLUSIONS: Inhaled fluticasone propionate < or =500 microg/day is an effective antiinflammatory therapy for mild to moderate asthma in adolescents and adults. The drug is more effective than nedocromil, theophylline or zafirlukast and is at least as effective as other inhaled corticosteroids administered at twice the fluticasone propionate dosage. The addition of inhaled salmeterol allows the use of lower maintenance dosages of fluticasone propionate. The drug is well tolerated and there is no evidence of a clinically significant effect of this dosage on HPA axis function. Hence, fluticasone propionate < or =500 microg/day is a particularly suitable agent for patients with mild to moderate asthma.

Administration, Inhalation↗
PubMed2005

Inhaled corticosteroids in chronic obstructive pulmonary disease: is there a clinical benefit?

Chronic obstructive pulmonary disease (COPD) is a serious illness that affects over 5% of the adult population. It is one of the few conditions for which the mortality and morbidity are still increasing. Experts expect COPD to become the third leading cause of death and the fifth leading cause of disability worldwide by the year 2020. Thus far, the only treatments that have been shown to make a difference to survival are smoking cessation and the use of oxygen supplements for those who are hypoxaemic at rest. The use of inhaled corticosteroids as monotherapy or in combination with a long-acting beta2-adrenoceptor agonist for COPD is controversial. Experimental data indicate that the inflammatory process in COPD may be resistant to the anti-inflammatory effects of corticosteroids. However, several large clinical studies have shown that inhaled corticosteroids in relatively high doses (e.g. budesonide 800 microg/day or fluticasone propionate 1 mg/day) reduce exacerbations by 20-30% and improve the health status of COPD patients by a similar amount compared with placebo. Withdrawal of inhaled corticosteroids may increase clinical exacerbation rates by 50% in COPD patients and by 2-fold in those with severe disease. Combined therapy with inhaled corticosteroids and long-acting beta2-adrenoceptor agonists may be superior to individual component therapy in reducing exacerbations. However, these medications must be used cautiously, as they have been associated with certain adverse effects. Inhaled corticosteroids, for instance, increase the risk for dysphonia and oral thrush by 2- to 3-fold. Skin bruising is also more common in users than in non-users of inhaled corticosteroids. On balance, for those with moderate-to-severe COPD and those who experience frequent exacerbations, judicious use of inhaled corticosteroids alone or in combination with long-acting beta2-adrenoceptor agonists appears reasonable.

Administration, Inhalation↗
PubMed2006

Inhaled human insulin (Exubera): a review of its use in adult patients with diabetes mellitus.

Inhaled human insulin (Exubera) (insulin human [rDNA origin]) Inhalation Powder) has recently been approved in the European Union and the US for preprandial use in adult patients with diabetes mellitus. This formulation of insulin has a more rapid onset, but similar duration, of glucose-lowering activity compared with subcutaneously administered regular human insulin. Preprandial inhaled human insulin provided glycaemic control that was comparable to preprandial subcutaneous regular insulin when added to long- or intermediate-acting subcutaneous basal insulin in patients with type 1 diabetes mellitus. Inhaled human insulin is also effective when administered alone, when combined with oral antihyperglycaemic therapy, or when combined with basal subcutaneous insulin in patients with type 2 diabetes mellitus. Comparable rates of hypoglycaemia occurred in patients treated with inhaled human insulin and in those treated with subcutaneous regular human insulin. Patients treated with inhaled human insulin demonstrated a greater decline in pulmonary function (forced expiratory volume in 1 second [FEV(1)], carbon monoxide diffusing capacity [DL(CO)]) than patients treated with comparator antihyperglycaemic agents; the mean difference between the treatment groups that favoured the comparators was noted within the first several weeks of treatment, and did not change over a 2-year treatment period. This agent has also been associated with significant improvements in some quality-of-life and treatment satisfaction scores, especially when compared with subcutaneous mealtime insulin regimens. Inhaled human insulin is an effective and well tolerated formulation suitable for preprandial use in combination with basal subcutaneous insulin in patients with type 1 diabetes. It is also well tolerated and effective in patients with type 2 diabetes when administered alone, when combined with oral antihyperglycaemic therapy, or when combined with basal subcutaneous insulin.

Administration, Inhalation↗
PubMed2001

Long-acting beta-agonist treatment in patients with persistent asthma already receiving inhaled corticosteroids.

International guidelines recommend that long-acting beta-agonists should be considered in patients who are symptomatic despite moderate doses of inhaled corticosteroids. When combined with inhaled corticosteroids they improve asthma symptoms and lung function and reduce exacerbations. The evidence suggests that they are well tolerated. However, they are less effective than inhaled corticosteroids as monotherapy and should not be used alone, although the addition of a long-acting beta-agonist may permit a small reduction in the corticosteroid dose. Both salmeterol and formoterol appear equally effective in improving asthma control. Formoterol, however, has a rapid onset of action and is now being promoted for the relief of acute asthma symptoms. Both drugs provide prolonged protection against exercise-induced bronchospasm. However, this effect rapidly diminishes with continuous therapy and if this is the main aim of treatment, intermittent use may be preferable. When compared with alternative treatments, inhaled long-acting beta-agonists are more effective in controlling asthma symptoms than either theophylline or antileukotriene agents. Bambuterol, an oral prodrug of terbutaline, appears to be as effective as the inhaled long-acting beta-agonists and has the advantage of once daily oral administration. However, the inhaled long-acting beta-agonists are less likely to have systemic adverse effects. There are theoretical concerns that regular beta-agonist treatment may lead to tolerance and a failure to respond to emergency asthma treatment. While there is no doubt that tolerance occurs, there is currently little evidence that this is a clinical problem. Insights into pharmacological as well as therapeutic interactions between inhaled corticosteroids and beta-agonists are providing justification for their use in combination. Guidelines for the management of patients with chronic persistent asthma are likely to require modification to reflect these developments.

Administration, Inhalation↗
PubMed2001

Comparative efficacy of inhaled corticosteroids and antileukotriene drugs in asthma.

Asthma is an inflammatory disease of the airways that is best treated by minimising exposure to factors that provoke the inflammation (e.g. allergens) and by administering drugs that reduce the inflammatory response. The cornerstone of asthma treatment is inhaled corticosteroids. Their effectiveness is a result of their potent and broad anti-inflammatory properties. Antileukotriene drugs (leukotriene modifiers) provide an alternative and novel approach to the treatment of asthma. The novelty of these new compounds is that their effectiveness is firmly based on the pathophysiology of asthma, specifically the role played by the cysteinyl leukotrienes. At the same time, the availability of the antileukotriene drugs has stirred debate over when they should be used and how they compare to inhaled corticosteroids. Although the answers are not fully known at this time, the currently available published and presented data are adequate for us to draw some conclusions about their relative effectiveness and role in asthma treatment. The antileukotriene drugs are more effective than placebo, but they are not as effective as inhaled corticosteroids in improving lung function [measured as the forced expiratory volume in 1 second (FEV(1)) or peak expiratory flow rate (PEFR)], reducing beta(2)-agonist use, and decreasing symptom-free days. In contrast, they may have similar beneficial effects on reducing asthma exacerbations and decreasing peripheral blood eosinophil counts. In the absence of knowing a priori the response of an individual patient to treatment with either therapy, the data favour initiating treatment with an inhaled corticosteroid. However, for patients with mild to moderate disease there are a number of circumstances that support using an antileukotriene drug first. A few examples are aspirin intolerance, predominantly exercise-induced symptoms and problems with using an inhaler or the adverse effects of inhaled corticosteroids such as dysphonia and thrush. For patients with more severe disease, inhaled corticosteroids remain the treatment of choice. Antileukotriene drugs should be considered as add-on therapy, especially in view of their possible complementary effects on reducing airway inflammation.

Administration, Inhalation↗
PubMed2000

Breath-synchronized nebulization diminishes the impact of patient-device interfaces (face mask or mouthpiece) on the inhaled mass of nebulized budesonide.

The choice of patient-device interface (face mask or mouthpiece) influences the inhaled mass and the lung deposition of nebulized drugs. The use of a mouthpiece has been shown to double the lung deposition compared with use of a face mask. We have determined the inhaled mass of budesonide using a jet nebulizer with mouthpiece in either a constant output or breath-synchronized mode in children. We have also determined the inhaled mass when the jet nebulizer is used with a nonsealing face mask in a constant output mode. The study was a 1-day, randomized, crossover, single-center study involving 158 asthmatic children (age range 5.1-15.7 years). Nebulized budesonide was administered in three single nominal doses of 1.0 mg by means of a jet nebulizer. The inhaled mass of budesonide was defined as the amount of drug deposited on filters positioned between the nebulizer and the mouthpiece or face mask. The mean inhaled mass of budesonide from different age groups ranged from 1 7.1% to 21.6% of the nominal dose with breath-synchronized nebulization with a mouthpiece. With constant output nebulization with a mouthpiece, the mean inhaled mass ranged from 8.9% to 12.2%, and with a nonsealed face mask the mean inhaled mass ranged from 5.0% to 6.9%. For children using jet nebulizers with mouthpiece, breath-synchronized nebulization appears to be superior to conventional constant output nebulization. The use of jet nebulizers with nonsealing face masks should be avoided.

Administration, Inhalation↗
PubMed1990

Effect of 4% lidocaine inhalation in bronchial asthma.

The effect of 4% lidocaine inhalation was studied in a single-blind fashion in 18 patients with chronic stable asthma. Inhalation of normal saline solution was used as placebo. None of the parameters except flow rate at 50% of vital capacity (V50) showed any statistically significant change from baseline values. V50 at 15 min was significantly lower (p less than 0.05) after 4% lidocaine inhalation. Considering more than 10% change from the baseline value as significant, 8 of 15 patients showed decrease in airway resistance (Raw) and 7 of the 15 patients showed an increase in specific airway conductance (SGaw) after 15 min of inhalation. However, V50 (8/18 patients), flow rate at 25% vital capacity [V25 (6/15 patients], and forced expiratory flow rate at 25-75% of the vital capacity (FEF25-75) (5/15 patients) showed a decrease after 15 min of 4% lidocaine inhalation. No change in pulmonary function was noted after 30 min of lidocaine inhalation. It is concluded from this study that lidocaine produces a small bronchodilatory effect on the large airways and a bronchoconstrictor effect on the small airways after 15 min of inhalation, but this effect is not statistically significant. It can be safely used as topical agent for bronchoscopy in patients with bronchial asthma.

Administration, Inhalation↗
PubMed1991

Sensitivity of FEV1 response following one and two inhalations of albuterol: a pilot study.

Eleven patients entered a pilot study designed to evaluate the proportion of eligible responders following a single inhalation of albuterol aerosol, the degree of response, and the sensitivity to distinguish between one and two inhalations based on FEV1 response. Each patient received a single inhalation at 0 and 60 minutes. FEV1 was measured 30 and 60 minutes after each inhalation. Most patients (82%) responded to a single inhalation and the majority (73%) were capable of further response after two inhalations. This study design was able to distinguish FEV1 responses to one and two inhalations of albuterol and provide upward and downward sensitivity sufficient to detect major differences in products.

Administration, Inhalation↗
PubMedDate not supplied

Cataract and ocular hypertension in children on inhaled corticosteroid therapy.

PURPOSE: To ascertain the incidence of posterior subcapsular cataract and ocular hypertension in a cohort of children < or = 12 years on inhaled steroid therapy. PATIENTS AND METHODS: In this prospective study, a detailed history regarding corticosteroid therapy was obtained for children attending an asthma clinic. The presence and type of lens changes (cataract) was recorded and intraocular pressure (IOP) was measured. The children underwent another eye examination 2 years later. RESULTS: Ninety-five patients were enrolled in the study. Mean patient age was 7 +/- 3 years, and mean duration of inhaled steroid therapy was 2 +/- 1 years. Thirty-six percent of patients received inhaled steroids exclusively, 61% received inhaled steroids with a short course of oral steroids, and 3% received inhaled steroids with a long course of oral steroids. Only 3 (3%) patients had cortical changes that were not visually significant, and none had posterior subcapsular or nuclear cataract. There was no significant differences between children with cataract and those without cataract with respect to age; duration of asthma; and duration, average daily dose, and cumulative dose of inhaled steroids. IOP ranged from 11 to 20 mm Hg (mean, 16 +/- 3 mm Hg). None of the children had ocular hypertension or glaucoma. Ninety patients underwent eye examination 2 years later; none was found to develop posterior subcapsular cataract or increased IOP. CONCLUSION: This study indicates the use of inhaled steroids in children with asthma is probably safe as far as not inducing posterior subcapsular cataract or ocular hypertension.

Administration, Inhalation↗
PubMed1987

Inhaled or reduced-dose intravenous pentamidine for Pneumocystis carinii pneumonia. A pilot study.

STUDY OBJECTIVE: To evaluate inhaled or reduced-dose intravenous pentamidine for the treatment of patients with mild Pneumocystis carinii pneumonia. DESIGN: Open, nonrandomized pilot study; measurement of pentamidine concentrations in plasma and bronchoalveolar lavage fluid. PATIENTS: Of 22 men with mild P. carinii pneumonia (PO2 greater than or equal to 55 mm Hg), 15 (9 in the inhaled group and 6 in the intravenous group) received treatment for their first episode and 7 for a repeat episode. INTERVENTIONS: Pentamidine isethionate, 4 mg/kg body weight by inhalation, or 3 mg/kg intravenously, was given once daily, as long as clinically indicated. MEASUREMENTS AND MAIN RESULTS: Of the 13 patients in the inhaled group, 9 has a satisfactory response; and of the 10 in the reduced-dose intravenous group, 9 had a satisfactory response. Major adverse reactions occurred in two patients in each group. Three patients in the inhaled group appeared to have had early relapses. Bronchoalveolar lavage fluid concentrations of pentamidine ranged between 16.8 +/- 7.3 ng/mL and 149.7 +/- 38.2 ng/mL in the inhaled group and 3.4 +/- 0.2 ng/mL and 10.9 ng/mL in the intravenous group. CONCLUSIONS: Inhaled or reduced-dose intravenous pentamidine may be an effective and less toxic therapy for mild P. carinii pneumonia. These regimens are not recommended for general use until larger controlled trials are conducted.

Acquired Immunodeficiency Syndrome↗
PubMed1990

Inhaled or intravenous pentamidine therapy for Pneumocystis carinii pneumonia in AIDS. A randomized trial.

OBJECTIVE: To compare inhaled pentamidine with intravenous pentamidine for the treatment of Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome (AIDS). DESIGN: A randomized trial. SETTING: Community teaching hospital and hospital-based outpatient treatment center. PATIENTS: Twenty-one homosexual men with pneumocystis pneumonia; 11 received inhaled pentamidine and 10 received intravenous pentamidine. INTERVENTION: Inhaled (8 mg/kg body weight) or intravenous (4 mg/kg body weight) pentamidine administered daily for 21 days. MEASUREMENTS AND MAIN RESULTS: All patients responded to intravenous pentamidine, whereas 6 of 11 (55%; 95% CI, 23% to 83%; P = 0.02, Fisher exact test) responded to inhaled pentamidine therapy. Two patients who failed inhaled pentamidine therapy eventually died despite appropriate intravenous therapy (mortality rate, 18%; CI, -6% to 42%). Nonresponders to inhaled pentamidine had a greater severity of illness compared with responders to this therapy, as shown by a lower mean (+/- SE) Pao2 (8.0 +/- 0.4 kPa compared with 10.8 +/- 0.6 kPa; P = 0.005) and higher alveolararterial Po2 difference (6.8 +/- 0.6 kPa compared with 2.8 +/- 0.8 kPa; P = 0.003). CONCLUSIONS: Inhaled pentamidine is probably as effective as intravenous pentamidine in patients with mild pneumocystis pneumonia. However, its use as sole therapy in patients with moderate to severe pneumocystis pneumonia is not supported by the results of our study and is not warranted.

Acquired Immunodeficiency Syndrome↗
PubMed1999

Effect of inhaled nitric oxide on gas exchange in patients with congestive heart failure. A randomized, controlled trial.

BACKGROUND: Conventional vasodilators increase ventilation-perfusion mismatch and do not improve gas exchange even though they reduce pulmonary hypertension. However, the effects of nitric oxide inhalation on ventilatory and gas exchange values in patients with congestive heart failure are not known. OBJECTIVE: To investigate the effect of nitric oxide inhalation on gas exchange in patients with congestive heart failure. DESIGN: Randomized, controlled trial. SETTING: University hospital. PATIENTS: 16 patients with congestive heart failure (New York Heart Association class II or III). INTERVENTIONS: Patients inhaled nitric oxide gas at graded concentrations (n = 8) or were given intravenous isosorbide dinitrate, 2.5 mg (n = 8). MEASUREMENTS: Hemodynamic and ventilatory variables and blood gases were measured 5 minutes after inhalation of different doses of nitric oxide and 10 minutes after administration of isosorbide dinitrate. RESULTS: Nitric oxide inhalation reduced the mean pulmonary arterial pressure in a dose-dependent manner without altering the mean arterial pressure or cardiac output. At a dose of 40 parts per million, nitric oxide inhalation increased PaO2 (change from baseline, 12.0 mm Hg [95% CI, 2.3 to 21.7 mm Hg]; P = 0.014) and decreased the alveolar-arterial difference in partial pressure of oxygen (change, -8.6 mm Hg [CI, -16.8 to -0.4 mm Hg]; P = 0.038) and the ventilatory equivalent for carbon dioxide output (change, -6.7 [CI, -10.3 to -3.1]; P < 0.001). Although isosorbide dinitrate similarly decreased pulmonary arterial pressure, it did not alter gas exchange or ventilatory variables. CONCLUSIONS: Because nitric oxide inhalation improved gas exchange, it may be used as a supportive therapy when other conventional vasodilators worsen gas exchange.

Administration, Inhalation↗
PubMed2000

Inhaled iloprost to treat severe pulmonary hypertension. An uncontrolled trial. German PPH Study Group.

BACKGROUND: Inhaled aerosolized iloprost, a stable prostacyclin analogue, has been considered a selective pulmonary vasodilator in the management of pulmonary hypertension. OBJECTIVE: To assess the efficacy of inhaled iloprost in the treatment of life-threatening pulmonary hypertension. DESIGN: Open, uncontrolled, multicenter study. SETTING: Intensive care units and pulmonary hypertension clinics at six university hospitals in Germany. PATIENTS: 19 patients who had progressive right-heart failure despite receiving maximum conventional therapy (12 with primary pulmonary hypertension, 3 with pulmonary hypertension related to collagen vascular disease without lung fibrosis, and 4 with secondary pulmonary hypertension). INTERVENTION: Inhaled iloprost, 6 to 12 times daily (50 to 200 microg/d). MEASUREMENTS: Right-heart catheterization and distance walked in 6 minutes at baseline and after 3 months of therapy. RESULTS: During the first 3 months of therapy, New York Heart Association functional class improved in 8 patients and was unchanged in 7 patients. Four patients died, 3 of right-heart failure and 1 of sepsis. The acute hemodynamic response to inhaled iloprost was predominant pulmonary vasodilatation with little systemic effect at baseline and at 3 months (data available for 12 patients). Hemodynamic variables were improved at 3 months, and the distance walked in 6 minutes improved by 148 m (95% CI, 4.5 to 282 m; P = 0.048). Of the 15 patients who continued to use inhaled iloprost, 8 stopped: Four had lung transplantation, 1 switched to intravenous prostacyclin therapy, and 3 died. Seven patients are still receiving inhaled iloprost (mean +/-SD) duration of therapy, 536 +/- 309 days; mean dosage, 164 +/- 38 microg/d). CONCLUSIONS: Inhaled iloprost may offer a new therapeutic option for improvement of hemodynamics and physical function in patients with life-threatening pulmonary hypertension and progressive right-heart failure that is refractory to conventional therapy.

Administration, Inhalation↗