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PubMed1998

A 1-year placebo-controlled study of intranasal fluticasone propionate aqueous nasal spray in patients with perennial allergic rhinitis: a safety and biopsy study.

In a 1-year, placebo-controlled, double-blind, randomized study the long-term effect of Fluticasone Propionate Aqueous Nasal Spray (FPANS) in 42 patients with a perennial allergic rhinitis was studied with regard to safety and efficacy. Twenty-nine patients completed the entire treatment period. After 1 year of treatment no deleterious changes consequent on therapy were observed in nasal mucosal biopsies. The appearance of the epithelial layer, the degree of cellular infiltration, the extent to which the sinusoids were dilated and the degree of tissue oedema improved or remained unchanged in 93% of the patients of the FPANS group, versus 75% of the placebo group, and worsened in 7% of the FPANS group versus 25% of the placebo group. Assessment of the changes in haematological, biochemical, urinary, plasma cortisol levels, and in the findings during nasal examination revealed no significant differences between the two treatment groups. After 1 year of treatment symptom scores for sneezing, nasal itching, and total symptom score were significantly better in the FPANS treated group (P < 0.05, P < 0.05, P < 0.01). An initial reduction in total symptom score was found after 4 weeks FPANS treatment with a further reduction after 8 months of FPANS treatment. These findings suggest that the maximum efficacy of topical intranasal steroids is reached after long-term treatment, and thus advocates longer usage before treatment is stopped because of presumed inefficacy.

Administration, Inhalation↗
PubMed1999

Effects of nicotine nasal spray on atherogenic and thrombogenic factors during smoking cessation.

OBJECTIVES: To investigate changes in cardiovascular risk factor parameters when stopping smoking and to identify any impact of nicotine nasal spray on these factors. DESIGN AND SUBJECTS: In a placebo-controlled, double-blind 3-month prospective study, nicotine nasal spray (NNS) or a placebo was given to 157 subjects attending a smoking cessation programme. Blood samples from 46 subjects who remained abstinent for 3 months were analysed. Nasal spray use was given on an ad libitum basis. RESULTS: The haemoglobin (Hb) decreased from 149.0 to 143.2 g L(-1) (P<0.001). The haematocrit (Hct) decreased from 44.6 to 42.4% (P<0.001). The mean corpuscular volume (MCV) decreased from 93.4 to 92.3 fl (P<0.001). The mean corpuscular haemoglobin concentration (MCHC) increased from 333.9 to 338.1 g L(-1) (P = 0.029). The white blood cell count (WBC) decreased from 8.4 to 6.6x10(9) L(-1) (P<0.001). The total cholesterol decreased from 5.92 to 5.65 mmol L(-1) (P = 0.015). The high-density lipoprotein cholesterol (HDL) increased from 1.29 to 1.44 mmol L(-1) (P = 0.48) and low-density lipoprotein cholesterol (LDL) decreased from 4.00 to 3.54 mmol L(-1) (P = 0.004). The HDL/LDL ratio increased from 0.36 to 0.46 (P = 0.011). CONCLUSION: Stopping smoking resulted in positive effects on cardiovascular risk factors. Nicotine treatment for as long as 3 months did not have any significant effect on these 'stopping smoking changes'. In smoking cessation, nicotine substitution up to 3 months seems to be safe.

Administration, Inhalation↗
PubMed2000

A double-blind, placebo-controlled steroid-sparing study with budesonide Turbuhaler in Japanese oral steroid-dependent asthma patients. Japanese Pulmicort Turbuhaler study group.

OBJECTIVE: The aim of this study was to evaluate the oral steroid-sparing capacity of budesonide Turbuhaler. METHODOLOGY: One hundred and thirteen oral steroid-dependent patients were treated for 6 months with placebo or budesonide 800 microg or 1600 microg daily. Every second week the oral steroid dose was reduced if asthma control permitted. RESULTS: The reductions in oral steroid doses were 9, 35 and 60% in the placebo and budesonide 800 microg and 1600 microg groups, respectively. Oral steroid treatment could be discontinued in 4% (placebo), 15% (800 microg) and 23% (1600 microg). Mean peak expiratory flow values increased by 21 and 24 L/min in the budesonide groups but decreased by 6 L/min in the placebo group. Asthma attack, activity and sleep scores remained unchanged showing maintained efficacy. Plasma cortisol levels increased and an adrenocorticotropic hormone test showed improved adrenocortical response in both budesonide groups, indicating improved safety. Adverse drug reactions were infrequent and mild in all study groups. CONCLUSION: Budesonide Turbuhaler, 800 microg and 1600 microg daily, resulted in a significant reduction in oral steroid usage in steroid-dependent patients. The effect was achieved with maintained asthma control together with improvements in lung and adrenal functions.

Administration, Inhalation↗
PubMed2004

Hypernatraemia induced by sodium polystyrene sulphonate (Kayexalate) in two extremely low birth weight newborns.

Hyperkalaemia is a life-threatening electrolyte disorder that can occur in the first week of life in almost 50% of preterm infants with a birth weight less than 1000 g [extremely low birth weight (ELBW)]. Serum potassium values higher than 7 mmol x l-1 are associated with cardiac arrhythmias and an increased incidence of intraventricular haemorrhage and periventricular leucomalacia. Therapeutic options to treat this dangerous imbalance comprise calcium gluconate, insulin plus glucose, albuterol/salbutamol inhalation. Administration of cation-exchange resin such as sodium polystyrene sulphonate (Kayexalate) is effective in lowering plasma potassium, although complications following oral or rectal administration are reported in newborns. We describe two ELBW infants affected by hyperkalaemia, treated with Kayexalate, who developed serious hypernatraemia, that has never been reported before in preterm infants.

Cation Exchange Resins↗
PubMed1999

Effects of systemic steroid treatment in chronic polypoid rhinosinusitis evaluated with magnetic resonance imaging.

BACKGROUND: The aim of this prospective study was to evaluate the efficacy of a combined (local and systemic) steroid therapy on the extent of chronic polypoid rhinosinusitis and patient symptoms. METHODS AND PATIENTS: Subjects of this study were 20 patients with severe chronic polypoid rhinosinusitis with total or subtotal narrowing of the all sinuses. A nasal budesonide spray (2 x 0.1 mg/day) and an oral fluocortolone medication with a daily reduction during a 12-day period (total dose: 560 mg = group 1) and a 20-day period (total dose: 715 mg = group 2), respectively, were administered. Before and after the steroid treatment we evaluated the extent of the sinusitis with MRI and patient symptoms with symptom-related questionnaires. RESULTS: A significant reduction (> 30%) of the chronic polypoid rhinosinusitis was observed in 50% of MRI findings. The steroid effect on polypoid masses was heterogeneous in different anatomic areas (maxillary sinus 40%, anterior ethmoid 19%, posterior ethmoid 33%, sphenoidal sinus 61%, frontal sinus 46%). Most sinusitis-related symptoms were distinctly diminished in most patients (80%). No major side effects were observed. CONCLUSIONS: A combined short-term steroid therapy is highly effective in chronic polypoid rhinosinusitis, reducing the mucosal inflammation mainly in the large sinuses and reducing the incidence of symptoms significantly. However, this therapy was insufficient in the anterior ethmoid and cannot replace the current surgical treatment concept of the osteomeatal complex in CPR. The indication for such a short-term steroid therapy is the preoperative treatment. It facilitates functional endoscopic sinus surgery by reducing the extent of surgical procedures, the time, and thereby the risks of sinus surgery.

Administration, Inhalation↗
PubMed2000

Effectiveness of Stadol NS (butorphanol tartrate) with ibuprofen in the treatment of pain after laser-assisted uvulopalatopharyngoplasty.

PURPOSE: Laser-assisted uvulopalatopharyngoplasty (LA-UPPP) is a recently developed technique for treating snoring and mild sleep apnea. This treatment is associated with severe postoperative pain. This study evaluated the effectiveness and safety of transnasal administration of butorphanol tartrate (Stadol NS; Bristol-Myers Squibb, New York, NY) as a primary means of controlling pain after this surgical procedure. PATIENTS AND METHODS: Twenty patients (14 men and 6 women; mean age, 43 years) were enrolled and treated with LA-UPPP and radiofrequency turbinate procedures (coblation) for severe snoring and chronic nasal congestion in an open label study. The same surgeon performed all procedures. Patients were advised to take 2 tablets of ibuprofen (200 mg each) and use a single 1 mg spray of Stadol NS in 1 nostril for the initial dose. If adequate pain relief was not achieved in 1 to 1.5 hours, an additional 1 mg dose of Stadol NS was recommended. Thereafter, they could repeat the ibuprofen and Stadol NS every 3 to 4 hours, as needed. Comprehensive preoperative and postoperative evaluations were made using a visual analog scale of 0 to 10, with 0 equal to no pain and 10 being the most severe. Patients were followed-up for 14 days. RESULTS: All 20 patients had LA-UPPP and nasal turbinate radiofrequency coblation, and all 20 were eligible for both efficacy and safety analysis. Pain was reduced from a mean of 6.6 to a mean of 3.3 (50%) after an average of 48 minutes after the initial dose. CONCLUSION: Stadol NS appears to be an effective treatment for moderate-to-severe pain after LA-UPPP. If patients have difficulty swallowing, which is the case with most throat surgeries performed by oral and maxillofacial surgeons and otolaryngologists, the transnasal route of administration reduces the number of oral medications taken by the patient.

Administration, Inhalation↗
PubMed2000

Efficacy of nebulized fluticasone propionate compared with oral prednisolone in children with an acute exacerbation of asthma.

The aim of the present study was to investigate the efficacy and safety of nebulized fluticasone propionate (FP Nebules) compared with oral soluble prednisolone in children with an acute exacerbation of asthma. The study used an international, multi-centre, randomized, double-blind, parallel group design. Three hundred and twenty-one patients, aged 4-16 years old, who presented with an acute exacerbation of asthma, were randomly allocated to either nebulized FP (1 mg b.d.) or oral prednisolone (2 mg kg(-1) day(-1) for 4 days then 1 mg kg(-1) day(-1) for 3 days) for 7 days. Patients in the FP group showed a significantly greater increase in diary card morning peak expiratory flow (PEF) over 7 days compared with patients in the prednisolone group (difference = 9.51 min(-1), CI = 2.1, 16.8, P = 0.034). Similar increases for both treatments were shown for evening PEF. Clinic PEF improved with both treatments, but was significantly greater in patients taking FP after 7 days (difference = 11.41 min(-1), CI = 2.8, 20.0, P = 0.029). Both treatments reduced symptom scores to a similar extent. The two treatments were well tolerated, and there was no difference in the incidence of adverse events. The present study demonstrated that nebulized FP is at least as effective as oral prednisolone in the treatment of children presenting with an acute exacerbation of asthma.

Acute Disease↗
PubMed2002

Assessment of asthma severity and treatment by GPs in Belgium: an Asthma Drug Utilization Research Study (ADUR).

A prospective study was performed between June 1996 and December 1997, to identify how general practitioners (GPs) in Belgium assess asthma severity and how they treat asthma according to their severity assessment. Three hundred and sixty-five GPs included 1376 already diagnosed and treated asthmatics. The GPs used a questionnaire providing data on patient demographics, aetiology of asthma, symptoms and medication use. The patients provided a complete diary card of day and night symptoms and morning and evening peak expiratory flow rates during a 3-week period. Asthma severity as assessed by GPs was compared with the severity according to the GINA guidelines. Along the same line, asthma treatment was evaluated according to the GPs assessment of severity and according to the GINA guidelines. Confronting the assessment of asthma severity by the GPs with the GINA criteria revealed that about 20% and 2% of the patients' asthma severity respectively were under- and over-estimated, respectively (using a discrepancy between GPs and GINA assessment of severity by 2 or more classes). Using the GINA criteria for treatment, only 37.5% of the patients seemed to be correctly treated. Taking a discrepancy between GINA assessment and treatment of two classes as an error, 2.3% and 23.4% of the asthmatics are over- and under-treated, respectively. In conclusion, this study provides evidence that GINA guidelines seem not to be adequately interpreted and implemented by GPs in Belgium. Improvement of the assessment of asthma severity is definitely needed and may lead to more appropriate use of asthma medication.

Acute Disease↗
PubMed2002

HPA-axis effects of nebulised fluticasone propionate compared with oral prednisolone in childhood asthma.

The aim of this study was to compare the effect of 7 days nebulised fluticasone propionate (FP) with oral prednisolone on 24-h urinary-free cortisol excretion, systemic exposure and safety. This was a randomised, double-blind, double-dummy, two-way crossover study. Thirty-one children (19 male, 12 female, mean age 8 years) with stable asthma were randomly assigned to 7 days treatment with either FP Nebules (2 x 0.5 mg/2 ml bd) or prednisolone tablets once daily (2 mg/kg/day for 4 days [maximum 40 mg] followed by 1 mg/kg/day or half the original dose for 3 days [maximum 20 mg]). After a 2-4 week washout period, patients received the second treatment for 7 days, followed by a 2-week follow-up visit. The primary outcome measure was 24-h urinary-free cortisol concentrations corrected for creatinine. Nebulised FP (1 mg bd) had significantly less effect on 24-h urinary-free cortisol excretion than oral prednisolone (8.9 ng/ml for FP and 5.0 ng/ml for prednisolone, P = 0.001). Systemic exposure to FP was also low. In conclusion, FP Nebules had significantly less effect on hypothalamic-pituitary-adrenal axis function than oral prednisolone in asthmatic children when used at doses recommended for the treatment of an acute exacerbation of asthma.

Administration, Inhalation↗
PubMed2002

Topical treatment of rhinosinusitis with fusafungine nasal spray. A double-blind, placebo-controlled, parallel-group study in 20 patients.

In a monocenter, placebo-controlled, double-blind, parallel-group study, 20 patients with acute symptoms of rhinosinusitis were treated with either fusafungine (CAS 1393-87-9, Locabiosol Dosier-Spray) (n = 10) or placebo nasal spray (n = 10). One patient from the placebo group was withdrawn from the study on the day of inclusion for noncompliance reasons. At the beginning of the 2-week treatment period, absence of an acute exacerbation of sinusitis with, e.g., opacity or fluid in any of the sinuses, was documented by computed tomography. Efficacy of treatment was assessed using objective measurements (e.g. sonography, rhinomanometry, acoustic rhinometry, and endoscopy) as well as scores recorded by the investigator on 6 consecutive visits before and after 1, 3, 7, 10, and 14 days of treatment, and by the patients on a diary card. Drug safety was evaluated on the basis of twice-daily assessment of general well-being and side effects. Statistical analysis of the data evidenced a positive effect of fusafungine as early as by the first 24 h of treatment (reduction of symptom score D0-->D1: p < 0.01), which was not seen in the placebo group (p = 0.2174). In the final assessment, both investigator and patients rated global efficacy better with fusafungine. In some instances, the intergroup difference achieved statistical significance (patient diaries, p = 0.0342). Side effects such as reactions at the application site mainly occurred in patients in the placebo group, who rated tolerability markedly worse than patients taking fusafungine (p = 0.0304; patient diaries, p = 0.0170).

Administration, Inhalation↗
PubMed2005

Role of bronchodilators in chronic obstructive pulmonary disease.

The prevalence of chronic obstructive pulmonary disease (COPD) continues to be on the rise. Bronchodilators are first line agents for the symptomatic management of this disease and have proven to be effective in both stable disease status and exacerbations. The stepwise escalation of therapy for COPD according to severity has been outlined in international guidelines. Different classes of bronchodilators exist. The most experience is available for short-acting beta-agonists and anticholinergics. These agents are mainly recommended for the treatment of mild COPD and for symptomatic patients on an as needed basis. Long-acting beta-agonists and anticholinergics have been developed more recently. They are more convenient to use for patients with advanced disease who require maintenance therapy with bronchodilators, and have been shown in this group of patients to provide superior efficacy compared with short-acting agents. Tiotropium, a long-acting anticholinergic, appears to be particularly powerful and may eventually replace ipratropium as the primary agent for COPD treatment. In contrast, the usage of theophylline, which used to be part of the mainstay of treatment for COPD, has declined, mainly secondary to a narrow therapeutic margin and side effects, but it is inexpensive and still has its role. New agents like phosphodiesterase-4-inhibitors are interesting substances that may become important adjuncts in COPD management, but there is limited experience so far. None of the bronchodilators have been shown to change outcome in COPD, but this issue is under active investigation.

Administration, Inhalation↗
PubMed1998

[The importance of bronchial hyperreactivity in anesthesiology].

Airways of patients with bronchial hyperreactivity (BHR) are characterised by exaggerated bronchoconstriction in response to a variety of stimuli; bronchospasm may be elicited during induction and maintenance of anaesthesia. The prevalence of BHR in normal populations is approximately 10%. BHR is an important feature of clinical asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis, atopy, upper respiratory tract infections and smoking. This review will outline some important aspects of the pathophysiological basis of BHR, i.e., neural and inflammatory mechanisms. Furthermore, it should assist in identifying patients at risk and update perioperative anaesthetic considerations. Prophylaxis of airway reflex activation and an appropriate anaesthetic plan should prevent airway constriction. Since tracheal intubation is the major risk factor to induce bronchospasm intubation should be avoided whenever possible and regional anaesthesia preferred. If tracheal intubation is unavoidable, propofol and ketamine can be recommended as induction agents. Prophylaxis of intraoperative bronchospasm and initial therapy, such as deepening of anaesthesia, inhalational administration of sympathomimetics and anticholinergics, and i.v. use of local anaesthetics and corticosteroids are outlined. Despite its popularity theophylline offers little benefit during anaesthesia. Adequate preoperative evaluation and preparation of the patient with BHR will contribute to optimising anaesthetic management of patients with BHR.

Anesthesia↗
PubMed1986

Acute cardiac events temporally related to cocaine abuse.

The increasingly widespread use of cocaine in the United States has been accompanied and perhaps exacerbated by the misconception that the drug is not associated with serious medical complications. In particular, the potential for cocaine to precipitate life-threatening cardiac events needs to be reemphasized. We report the clinical and pathological findings in seven people in whom nonintravenous "recreational" use of cocaine was temporally related to acute myocardial infarction, ventricular tachycardia and fibrillation, myocarditis, sudden death, or a combination of these events. We also review data on 19 previously reported cases of cocaine-related cardiovascular disorders. Analysis of all 26 patients indicated the following findings: the cardiac consequences of cocaine abuse are not unique to parenteral use of the drug, since nearly all the patients took the drug intranasally; underlying heart disease is not a prerequisite for cocaine-related cardiac disorders; seizure activity, a well-documented noncardiac complication of cocaine abuse, is neither a prerequisite for, nor an accompanying feature of, cardiac toxicity of cocaine; and the cardiac consequences of cocaine are not limited to massive doses of the drug. Although the pathogenesis of cardiac toxicity of cocaine remains incompletely defined, available circumstantial evidence suggests that cocaine has medical consequences that are equal in importance to its well-documented psychosocial consequences.

Administration, Inhalation↗
PubMed2003

Long-term treatment with aspirin desensitization in asthmatic patients with aspirin-exacerbated respiratory disease.

BACKGROUND: Aspirin desensitization treatment is an option to decrease disease activity and reduce the need for systemic corticosteroids in patients with aspirin-exacerbated respiratory disease (AERD). OBJECTIVE: This study was designed to determine whether the clinical courses of patients with AERD improved as early as 6 months after starting aspirin desensitization and to compare this with follow-up evaluations after at least a year. METHODS: Between 1995 and 2000, 172 patients with AERD were admitted to our General Clinical Research Center, were desensitized to and treated with aspirin, were discharged to their home communities, and participated in follow-up interviews and written assessments of their clinical courses. RESULTS: By the first 6 months of aspirin treatment, there were significant reductions in sinus infections and numbers of short courses of prednisone and improvements in sense of smell and general assessment of nasal-sinus and asthma symptoms (P <.0001). These results persisted for 1 to 5 years (P <.0001). Mean prednisone doses decreased from 10.8 mg/d to 8.1 and 3.6 mg/d at 6 months and greater than 1 year, respectively. Of the 172 patients, 24 (14%) discontinued aspirin treatment because of side effects, and 115 (67%) responded to aspirin treatment. After eliminating those who discontinued aspirin treatment because of side effects, the improvement rate was 115 (78%) of 148 patients. Of the 126 patients who completed a year or more of aspirin treatment, 110 (87%) experienced improvement. CONCLUSION: Aspirin desensitization followed by daily aspirin is efficacious by at least the first 6 months of treatment and continues to be effective for up to 5 years of follow-up.

Administration, Inhalation↗
PubMed2003

Pharmacokinetics and tissue distribution of the nonadecapeptide Moli1901 in rats and mice.

1. Administration of aerosolized, radiolabelled Moli1901 (duramycin, 2622U90), a 19 amino acid polycyclic peptide, to rats resulted in the deposition of high amounts of radiolabel in the respiratory tract, with deposited radiolabel persisting almost unchanged through 7 days after dosing. Little to no radiolabel was present in the bloodstream of these rats. 2. Rats absorbed little radiolabel after p.o. administration, with nearly all of the dose excreted in the faeces by 2 days after dosing. 3. At 7 days following an intravenous dose, rats excreted 54% of the radiolabel in faeces and 5.4% in the urine, with 44% remaining in the carcass, primarily in the liver (33%). 4. Following an intratracheal instillation dose to rats, radiolabel was eliminated from the pulmonary system with a half-life of 64 days. Excretion was almost exclusively via faeces, with an elimination half-life of 52 days. Plasma and blood concentrations in these animals were uniformly <1 ng eq. ml(-1) at all sampling times. 5. Results in mice given intravenous and oral doses were consistent with those observed in rats. 6. Prolonged retention of Moli1901 in pulmonary tissue supports its use in the treatment of respiratory diseases.

Administration, Inhalation↗