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PubMed2005

Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes. An analysis of initial phase II and III inhaled insulin (Exubera) trials and a two-year extension trial.

OBJECTIVE: To compare antibody responses to inhaled human insulin vs. sc human insulin and to determine whether insulin antibody binding is associated with adverse clinical consequences. RESEARCH DESIGN AND METHODS: Insulin antibody data from initial phase II/III trials were analyzed comparing the efficacy and safety of inhaled insulin with various agents, including sc insulin. Additionally, data from a 24-month extension of the phase III studies were examined. Data were pooled into the following three groups based on insulin treatment status at baseline: patients with type 1 diabetes, and patients with type 2 diabetes using insulin and not using insulin at baseline. Ig class analysis was also performed on randomly selected sera from type 1 patients at the end of the initial trials. RESULTS: In the initial trials, greater insulin antibody binding was observed in patients receiving inhaled insulin vs. sc insulin. The greatest antibody responses to inhaled insulin were observed in patients with type 1 diabetes [nonparametric comparison of medians at the end of the study, 22.0% binding (unadjusted 95% confidence interval: 19.5, 24.5)], and the lowest responses were observed in non-insulin-using patients with type 2 diabetes in which there was no difference in median values at the end of the study. There were no correlations between antibody binding and glycemic control (measured using glycosylated hemoglobin), insulin dose requirements, hypoglycemic events, or pulmonary function (measured by changes in forced expiratory volume in 1 sec and diffusion capacity of carbon monoxide). Antibody responses were IgG in type. Differences in antibody levels observed in patients with type 1 vs. type 2 diabetes were maintained over the 24-month extension trials. Peak antibody levels across all groups were generally observed after 6-12 months of insulin therapy. Inhaled insulin therapy was not associated with a greater incidence of allergy or other hypersensitivity reactions. CONCLUSION: Inhaled insulin was observed to produce a larger antibody response than sc insulin. Insulin antibody binding has not been associated with adverse clinical consequences in trials to date.

Administration, Inhalation↗
PubMed2001

The role of leukotriene receptor antagonists in the treatment of chronic asthma in childhood.

A considerable increase in the prevalence of childhood asthma over the last few decades has been mirrored by a dramatic increase in usage of anti-asthma drugs; however, there has been no reduction in the numbers of patients dying of asthma. Concern has been expressed about the development of tolerance with continuous use of inhaled beta-agonist bronchodilators and about the potential adverse systemic effects of high-dose inhaled corticosteroids in children. Moreover, patient compliance with inhaled therapy tends to be poor. The leukotriene receptor antagonists, including montelukast, pranlukast and zafirlukast, are orally administered agents with proven benefits in asthma. In a large, placebo-controlled pediatric trial, montelukast significantly (P < 0.02) reduced requirements for rescue beta-agonist bronchodilators, improved quality of life, reduced the circulating level of blood eosinophils and produced improvements in lung function. In adult studies, montelukast reduced sputum eosinophils and attenuated early and late phase allergen-induced reactions. Montelukast has also demonstrated protective effects against exercise-induced bronchospasm in both adults and children, and this protection was maintained during the trough period at the end of the once-daily administration interval (namely, 20-24 h post-dose). Several studies have demonstrated that the formation of cysteinyl leukotrienes in the airways of asthmatic patients is not suppressed by corticosteroids; thus, it is not surprising that montelukast demonstrates complementary effects when given with inhaled corticosteroids. Currently, the most compelling evidence from published trials suggests that leukotriene receptor antagonists can be used as add-on therapy to inhaled corticosteroids to allow tapering of corticosteroid dose and reduction in beta-agonist use. Recent clinical trial results suggest there may also be a role for these agents as first-line therapy in children with mild asthma.

Anti-Asthmatic Agents↗
PubMed1999

Oral prednisolone followed by inhaled budesonide in newly diagnosed pulmonary sarcoidosis: a double-blind, placebo-controlled multicenter study. Finnish Pulmonary Sarcoidosis Study Group.

STUDY OBJECTIVE: To evaluate the efficacy of oral prednisolone, followed by inhaled budesonide, in patients with newly diagnosed (<3 months) stage I and stage II pulmonary sarcoidosis. DESIGN: Double-blind, placebo-controlled, parallel-group, multicenter study. SETTING: Twenty pulmonary medicine departments in Finland. PATIENTS: One hundred eighty-nine adult patients were randomized to treatment. Patients with erythema nodosum or stage IV sarcoidosis (pulmonary fibrosis), and patients requiring immediate treatment with oral corticosteroids for extrapulmonary lesions or chronic illnesses were excluded. TREATMENT: The patients received either oral prednisolone for 3 months (20 mg/d for 8 weeks, 15 mg/d for 2 weeks, and 10 mg/d for 2 weeks) followed by inhaled budesonide (Pulmicort Turbuhaler; Astra Draco; Lund, Sweden) for 15 months at 800 microg bid, or placebo tablets followed by placebo inhaler therapy. MEASUREMENTS: Chest radiographs, lung volumes (FVC), diffusing capacity of the lung for carbon monoxide (D(LCO)), serum angiotensin-converting enzyme (SACE), and beta2-microglobulin at 3-month intervals. RESULTS: After 3 months of treatment, radiographic improvements were seen in the active-treatment group when compared to the placebo-treatment group. At 6 months, the difference was still statistically significant. Later, no differences were found. In patients with initial stage I lesions, neither the FVC nor the D(LCO) (the percent predicted mean values) changed during the study, as they were normal from the beginning. In patients with initial stage II disease, the difference in the FVC mean values between the groups also remained unchanged throughout the study. In stage II patients treated for 18 months, but not earlier, the difference in D(LCO) became statistically significant; the largest differences were seen in patients with initial FVC values <80% of predicted and D(LCO) values <75% of predicted. The decrease in SACE in the active-treated stage II patients was significantly larger than in the placebo-treated patients. No difference was observed in adverse events between the active-treated patients and the placebo-treated patients. CONCLUSION: Treatment is not required for patients with stage I disease. An initial treatment with prednisolone followed by long-term inhalation of budesonide is more effective than placebo in patients with stage II disease. Sequential oral and inhaled corticosteroid therapy may be an alternative treatment regimen for stage II sarcoidosis patients, rather than long-term oral corticosteroid therapy alone.

Administration, Inhalation↗
PubMed2005

Assessment of use of spacer devices for inhaled drug delivery to asthmatic children.

In the treatment of bronchial asthma, inhaled therapy with both bronchodilators and corticosteroids represents the basis for acute and long-term management. Drug therapy in asthma is predominantly by pressurized metered dose inhalers. The impact of treatment on the disease morbidity and mortality depends to a large extent on appropriate delivery of drug to the lungs by means of a spacer device. We performed an audit on spacer use in 200 children and showed that 99% owned a spacer, 2% owned but did not use their spacer, 11% were using a spacer which was not ideal for their age, 17% had a poor technique, and 24% were not following the recommendations given on previous visits to wash the spacer only with a soapy solution. Although physicians frequently associate poor control of asthma with inadequate doses of drugs, many factors must be considered before increasing the dose of inhaled medications to children. We should all ensure that the drugs we prescribe are delivered in the best possible manner, thus improving control of asthma, reducing side effects and offering a more cost-effective therapy.

Administration, Inhalation↗
PubMed1992

Morbidity associated with asthma and audit of asthma treatment in out-patient clinics.

A study was undertaken to determine the extent of morbidity associated with asthma and to audit the management of asthma in two out-patient clinics of two district hospitals. Patients were recruited for the study during a 3-month period from December 1990 to February 1991. Seventy asthmatic patients were studied. Eighty-six percent of the patients had their sleep disturbed by asthma, 77% took daily medication regularly, 63% felt that their activities were restricted by asthma, 60% had at least one acute exacerbation in the preceding six months. Of those who had their peak expiratory flow rate (PEFR) measured, 40% had a PEFR below 50% predicted, and only 11% had normal PEFR (greater than 80% predicted). The morbidity of asthma was thus considerable. On the other hand, the drug treatment of these asthmatics was grossly inadequate. They were prescribed on average 2.1 item of drugs, which for most patients comprised an oral beta agonist and a theophylline. Only 43% of the patients received inhaler therapy, but no patients were given steroids, inhaled or oral. The drug treatment was unrelated to the severity of patients' asthma. Further, objective measurement of severity was under-used in the assessment of asthma, only 8.5% of patients ever had their PEFR recorded. This study has found that asthma is poorly managed in out-patient clinics. We need to improve the training of doctors in the optimal management of asthma.

Adolescent↗
PubMed1997

Inhaled nitric oxide and hypoxic respiratory failure in infants with congenital diaphragmatic hernia. The Neonatal Inhaled Nitric Oxide Study Group (NINOS).

OBJECTIVE: We designed and conducted a randomized, double-masked, controlled multicenter study to determine whether inhaled nitric oxide (INO) in term and near-term infants with congenital diaphragmatic hernia (CDH) would reduce the occurrence of death and/or the initiation of extracorporeal membrane oxygenation (ECMO). PATIENTS AND METHODS: Infants of 34 weeks gestation or more, <14 days of age with CDH, without known structural heart disease, requiring assisted ventilation for hypoxemic respiratory failure with two oxygenation indices (OIs) of 25 or more at least 15 minutes apart, were eligible for this trial. Infants were centrally randomized and then received masked treatment with 20 ppm NO or 100% oxygen as control. Infants with less than a full response to 20 ppm NO (increase in PaO2 > 20 Torr) after 30 minutes were evaluated at 80 ppm NO/control study gas. RESULTS: The 28 control and 25 treated infants enrolled by the 13 participating centers were not significantly different at randomization for any of the measured variables including prerandomization therapies and initial OIs (45.8 +/- 16.3 for controls, 44.5 +/- 14.5 for INO). Death at <120 days of age or the need for ECMO occurred in 82% of control infants compared with 96% of INO infants (ns). Death occurred in 43% of controls and 48% of the INO group (ns), and ECMO treatment was used for 54% of control and 80% of INO-treated infants. There was no significant improvement in PaO2 (delta PaO2 7.8 +/- 19.8 vs 1.1 +/- 7.6 Torr, ns) nor significant reduction in OI (-2.7 +/- 23.4 vs 4.0 +/- 14.8, ns) associated with INO treatment. Mean peak nitrogen dioxide (NO2) concentration was 1.9 +/- 1.3 ppm and the mean peak methemoglobin was 1.6 +/- 0.8 mg/dL. No infant had study gas discontinued for toxicity. There were no differences between the control and INO groups for the occurrence of intracranial hemorrhage, specific grades of intracranial hemorrhage, periventricular leukomalacia, brain infarction, and pulmonary or gastrointestinal hemorrhages. CONCLUSIONS: Although the immediate short-term improvements in oxygenation seen in some treated infants may be of benefit in stabilizing responding infants for transport and initiation of ECMO, we conclude that for term and near-term infants with CDH and hypoxemic respiratory failure unresponsive to conventional therapy, inhaled NO therapy as used in this trial did not reduce the need for ECMO or death.

Administration, Inhalation↗
PubMed1998

Inhaled nitric oxide therapy for pulmonary disease in pediatrics.

Inhaled nitric oxide (iNO) therapy improves gas exchange and lowers pulmonary vascular resistance in neonates and children with diverse cardiac and pulmonary disorders. Recent multicenter studies have shown that iNO reduces the need for rescue therapy with extracorporeal membrane oxygenation in term neonates with severe hypoxemic respiratory failure. In neonates with severe lung disease, responsiveness to iNO therapy can be enhanced by therapies which enhance lung recruitment, especially high-frequency oscillatory ventilation. Although early studies suggest that iNO therapy is not associated with significant clinical toxicity or adverse effects, more data are needed on long-term neurodevelopmental and pulmonary outcomes. Acute iNO treatment can improve oxygenation in nearly 70% of older infants and children with acute respiratory distress syndrome, but multicenter studies have yet to demonstrate that prolonged iNO therapy can improve outcome in these patients. Further studies are needed to better identify the exact role for iNO therapy in cardiopulmonary diseases associated with hypoxemia or pulmonary hypertension.

Administration, Inhalation↗
PubMed1998

[Nitric oxide in the treatment of COPD-induced chronic cor pulmonale: therapeutic effect and mechanism].

OBJECTIVE: To study the hemodynamic and oxygen-dynamic effects and the mechanism of nitric oxide (NO) inhalation therapy in COPD-induced chronic cor pulmonale at acute exacerbation period. METHOD: Right heart catheterization was performed in 11 cases of chronic cor pulmonale. The hemodynamic parameters and plasma endothelium-I(ET-I) level were examined and recorded before and after inhalation of 40 ppm NO for 20 minutes. The plasma level of NO and lipid peroxide Ca(2+)-Mg(2+)-ATPase(calcium pump) and Na(+)-K(+)-ATPase (natrium pump) activities of RBC membrane in 30 cases of chronic cor pulmonale and 30 healthy controls were determined synchronously. RESULTS: After NO therapy, the average pulmonary pressure (PAPM) and pulmonary vascular resistance index (PVRI) were lowered by 16.6% and 25.9% respectively (P < 0.05). Intrapulmonary shunt was lowered by 16.3% (P < 0.05). ET-I also lowered and showed a positive correlation with PAPM (r = 0.59, P < 0.05). The activities of calcium and natrium pump were lowered when NO level declined, showing a positive correlation with NO concentration and negative correlation with lipid peroxides. CONCLUSION: No inhalation therapy exerted favorable hemodynamic and oxygen-dynamic effects on COPD-induced chronic cor pulmonale in its exacerbation period. Suppression of ET-I release might be one of the important factors for pulmonary vessel relaxation. Dysfunction of calcium and natrium pump activities in the acute exacerbation period of chronic cor pulmonale were closely related to NO level.

Administration, Inhalation↗
PubMedDate not supplied

Readability characteristics of consumer medication information for asthma inhalation devices.

PURPOSE: Successful control of asthma relies heavily on patient adherence to prescribed inhalation therapies. Many patients are unable to use inhalers correctly and, therefore, do not reap the full therapeutic benefits. The purpose of this study was to assess the readability and related characteristics of Consumer Medication Information (CMI) for all prescription asthma inhalation devices currently available in the United States. METHODS: We identified all brand-name (n = 18) and generic (n = 2) asthma inhalation devices currently available in the United States. English language CMI was obtained from pharmaceutical manufacturers of each identified product. The CMI from these products was evaluated for readability characteristics, including reading grade level using the Fry formula, text point size, dimensions (length and width), diagrams, and directions. RESULTS: The mean Fry readability of the CMI was at grade level 8.2 +/- 1.5 (range = 5-11), while the average text point size was 9.2 +/- 2.2 (range = 6-12). The mean length of the pages on which the CMI was printed was 33.7 +/- 21.5 cm, while the average width of pages was 12.9 +/- 9.5 cm. There was an average of 6.2 +/- 3.6 (range = 2-12) illustrations per CMI, while a device overview diagram was included in 14 (70%). Eleven (n = 11) instructions included detailed step-by-step diagrams to supplement directions. CONCLUSIONS: Overall, most CMI for prescription inhalers is presented with a reading difficulty level, text size, diagrams, and instructions that make it suboptimal for patient education. Prescription inhaler manufacturers should consider revising their CMI to comply with generally accepted guidelines preparing patient education information.

Asthma↗
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↗
PubMed1997

Delivery systems: the science.

Different delivery devices may be chosen and the prescribing physician requires information on those suitable for patients of different age, together with the reproducibility of the dose inhaled from the chosen device. A large number of different devices are currently available for inhalation therapy. Although the dose of a drug inhaled by a patient from a device may vary by up to 400%, such information is not usually available to the prescribing doctor. Spacer devices, with facemask attachments for younger children, are now the first choice device for delivery of anti-asthma aerosols to those 5 years of age or less. The dose that spacer devices deliver is governed by a variety of factors, including static charge, face mask design, spacer volume, the particular drug used, and the breathing pattern of the child. Nebulizers are generally prescribed for those not tolerating spacer devices. More recent designs, such as the open-vent nebulizer systems deliver the drug more rapidly to adults. The breath-enhanced open-vent systems have the advantage of delivering significantly more drug to older patients. These systems rely on the relatively large tidal volumes of older patients. As a result of their smaller tidal volumes, young children are unlikely to benefit as greatly from these devices. The open-vent system may result in some young children receiving less drug than from a conventional nebulizer.

Adolescent↗
PubMed1972

A rehabilitation program for improving exercise tolerance of patients with chronic lung disease.

A Chronic Chest Disease Rehabilitation Program has been developed in the Toronto General Hospital to improve exercise tolerance in very disabled patients. The most important part of the program is physical conditioning using mainly a motor-driven treadmill. The treadmill exercise is done breathing room air or, in the case of the most disabled patients, an oxygen-enriched gas mixture. Other exercise includes riding a stationary bicycle, going up and down stairs, and turning a wheel by hand. Other aspects of the program are breathing exercises, inhalation therapy using an ultrasonic nebulizer, chest physiotherapy, and patient education. The importance of a team approach with encouragement, enthusiasm and demonstration of steady progress is emphasized.

Breathing Exercises↗
PubMed2004

Therapeutic approaches in metastatic renal cell carcinoma: local immunotherapy.

Since 1990, aerosol interleukin (IL)-2 has been used to treat pulmonary metastatic renal cell carcinoma (pmRCC). Inhalation therapy deposits a drug into the airways to achieve a high, local, clinical effect while avoiding serious systemic side effects. We report three studies to describe safety and efficacy of aerosol IL-2 in patients with pmRCC. In a multicenter study, 24 patients received exclusive inhalation (study I) of natural IL-2 (three dose levels, 48 weeks) and response and toxicity were evaluated. The survival of high-risk patients (study II) with mainly inhaled IL-2 (n=94) was compared with that of patients receiving systemic IL-2 (n=103). In ten patients we analyzed in detail lung function and markers of airway inflammation before and during inhalational IL-2 therapy (study III). Study I: The response of exclusive inhalation was 33.3% at 3 months and 16.7% at 6 months. Treatment was well tolerated, cough being the most frequent adverse event. Study II: The probabilities of survival at 5 years were 21% for the inhalational group and 0% for the systemic group. Study III: Inhaled IL-2 induced a moderate decline of forced expiratory volume (FEV), while exhaled nitric oxide (NO) and sputum eosinophils rose accompanied by moderate cough and dyspnea. In conclusion, inhalational IL-2 combines good efficacy and improves tolerability. This is especially important for patients who are not able to benefit from systemic IL-2 therapy. Whether the local eosinophilic response additionally supports the antitumor effect remains a challenging question.

Administration, Inhalation↗
PubMed2005

The expanding role of aerosols in systemic drug delivery, gene therapy, and vaccination.

Aerosolized medications have been used for centuries to treat respiratory diseases. Until recently, inhalation therapy focused primarily on the treatment of asthma and chronic obstructive pulmonary disease, and the pressurized metered-dose inhaler was the delivery device of choice. However, the role of aerosol therapy is clearly expanding beyond that initial focus. This expansion has been driven by the Montreal protocol and the need to eliminate chlorofluorocarbons (CFCs) from traditional metered-dose inhalers, by the need for delivery devices and formulations that can efficiently and reproducibly target the systemic circulation for the delivery of proteins and peptides, and by developments in medicine that have made it possible to consider curing lung diseases with aerosolized gene therapy and preventing epidemics of influenza and measles with aerosolized vaccines. Each of these drivers has contributed to a decade or more of unprecedented research and innovation that has altered how we think about aerosol delivery and has expanded the role of aerosol therapy into the fields of systemic drug delivery, gene therapy, and vaccination. During this decade of innovation, we have witnessed the coming of age of dry powder inhalers, the development of new soft mist inhalers, and improved pressurized metered-dose inhaler delivery as a result of the replacement of CFC propellants with hydrofluoroalkane. The continued expansion of the role of aerosol therapy will probably depend on demonstration of the safety of this route of administration for drugs that have their targets outside the lung and are administered long term (eg, insulin aerosol), on the development of new drugs and drug carriers that can efficiently target hard-to-reach cell populations within the lungs of patients with disease (eg, patients with cystic fibrosis or lung cancer), and on the development of devices that improve aerosol delivery to infants, so that early intervention in disease processes with aerosol therapy has a high probability of success.

Administration, Inhalation↗
PubMed1982

[Probability of survival and prognostic factors in chronic obstructive lung disease].

The course of chronic obstructive pulmonary disease (COPD) is described over a 3-7 year period in 201 patients treated by family physicians and in the same hospital. The probability of survival after 3 years is 63% (normal population of same age 85%) and after 5 years 48% (normal 75%) for all patients. These figures are comparable with data in the literature of the last 12 years (42-69% 5-year survival). The patients in our study are 68 years old on average and have an FEV1 of 1.3 liters. The prognosis of COPD is significantly influenced by the following factors: ECG signs of cor pulmonale, clinical signs of heart failure, vital capacity, FEV1 and paCO2. For example, within a 3 year period 63 of 124 patients with heart failure died as compared to only 3 of 57 without. Retrospective analysis shows inhalation therapy by motor-driven nebulizers to have a favourable effect on survival. For IPPB home therapy a favourable effect can only be shown after stratification for the two most significant prognostic factors to exclude therapeutic bias. No effect on survival was noted with long-term steroid therapy. 11% of patients who have never smoked, and those who have stopped smoking, live significantly (p less than 0.002) longer than those who continued to smoke more than 3 cigarettes per day during the observation period.

Aged↗
PubMed1997

Ciprofloxacin as antipseudomonal treatment in patients with cystic fibrosis.

OBJECTIVE: The efficacy and safety of oral ciprofloxacin as a maintenance antipseudomonal therapy were evaluated in 44 patients with cystic fibrosis who had completed a 14-day regimen of intensive hospital therapy with intravenous ceftazidime and amikacin, supplemented by amikacin inhalation therapy. METHODS: Twenty-one patients were randomly assigned to oral ciprofloxacin alone (Group I) and 23 received ciprofloxacin plus inhaled amikacin (Group II). RESULTS: Negative sputum cultures were achieved in 34 patients (77%) at the end of intensive therapy (19 Group I and 15 Group II) and were sustained after 3 months of maintenance therapy in 5 of the 19 responders in Group I (26%) and in 8 of the 15 responders in Group II (53%). Resistance to ciprofloxacin was found in 7 of 31 (23%) sputum isolates at the end of ciprofloxacin therapy. During maintenance therapy, continued improvement in clinical symptoms was observed in 14 patients in both treatment groups; 6 in each group had further improvements whereas only 4 patients were clinical failures. There was no correlation between clinical outcome and either elimination of Pseudomonas aeruginosa from sputum culture or development of ciprofloxacin resistance. Both maintenance regimens were well-tolerated by this population of patients which included 28 children younger than 15 years of age. There were no severe or serious adverse events, no signs of quinolone-related arthropathy and no growth impairment. CONCLUSION: Ciprofloxacin was efficacious, safe and well-tolerated as maintenance antipseudomonal therapy in cystic fibrosis patients. These results suggest further evaluation of ciprofloxacin as an oral maintenance therapy is warranted.

Adolescent↗
PubMed2002

Coincidence of immune-mediated diseases driven by Th1 and Th2 subsets suggests a common aetiology. A population-based study using computerized general practice data.

BACKGROUND: The recent rise in the prevalence of immune-mediated diseases has been attributed to environmental factors such as a lack of microbial challenge, or dietary change, that deviate the overall balance between mutually antagonistic subsets of T helper (Th) cells. OBJECTIVE: An alternative proposal is that recent environmental changes have resulted in an immune system that is more likely to produce both Th1 and Th2 responses against benign antigens. The prediction of this hypothesis, that Th1 and Th2-mediated diseases are not mutually exclusive, and may be positively associated, is tested here in a whole population. METHODS: Data from General Practices participating in the Scottish Continuous Morbidity Recording (CMR) project were used to determine the coincidence of the major Th2-mediated atopic diseases; asthma, eczema and allergic rhinitis, with the Th1-mediated autoimmune conditions; type I diabetes, rheumatoid arthritis and psoriasis. We also identified the prescription rates of inhaled therapy for asthma in patients with Th1-mediated disease. RESULTS: There was a significant increase in the risk of presenting with a Th1-mediated autoimmune condition in patients with a history of allergic disease (standardized prevalence ratio (95% confidence interval) 1.28 (1.18-1.37)). Likewise, the standardized prevalence ratios of presenting with either eczema (1.67 (1.48-1.87)) or allergic rhinitis (1.22 (1.02-1.44)) were significantly increased in subjects with a history of Th1-mediated disease. There was a particularly strong association between current psoriasis and current eczema (standardized prevalence ratio ofpsoriasis in subjects with eczema 2.88, 95% confidence interval (CI) 2.38-3.45). There was also a significant increase in prescriptions for inhaled asthma therapy in patients with Th1 disease. CONCLUSION: It is concluded that Th1- and Th2-mediated diseases are significantly associated in a large General Practice population. This finding supports the proposal that autoimmune and atopic diseases share risk factors that increase the propensity of the immune system to generate both Th1- and Th2-mediated inappropriate responses to non-pathological antigens.

Adolescent↗
PubMed1999

Use of gamma scintigraphy to evaluate the performance of new inhalers.

Many new inhaler devices and formulations involving pressurized metered dose inhaler (pMDI), dry powder inhaler (DPI), and liquid spray technologies are currently being developed. Some of these novel drug delivery products deposit a greater percentage of the drug dose in the lungs than a conventional chlorofluorocarbon (CFC)-based pressurized aerosol, hence providing better drug targeting to the required site of drug action. The noninvasive imaging technique of gamma scintigraphy provides an accurate quantification of the amount of drug deposited in the lungs from inhaler devices together with an assessment of deposition in different lung regions. Respimat (Boehringer Ingelheim, Ingelheim am Rhein, Germany) is a novel liquid spray "soft mist inhaler" that more than doubles deposition in the lungs compared with a pMDI and reduces oropharyngeal deposition, thus providing a degree of drug targeting comparable to that from a spacer device. These data suggest that Respimat should be a valuable addition to the range of devices available for inhalation therapy.

Administration, Inhalation↗