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PubMed2005

Efficacy of a management plan based on severity assessment in longitudinal and case-controlled studies of 747 children with nut allergy: proposal for good practice.

BACKGROUND: There are few data on the long-term management of children with peanut/nut allergy. Advice is variable and often inadequate; further reactions are common. There is no consensus on the criteria for prescription of rescue medication, particularly adrenaline. METHOD: A longitudinal prospective and case-control study in a tertiary allergy clinic. Patients/parents/school staff of 747 children with confirmed peanut or tree nut allergy received detailed verbal and written advice on nut avoidance, training in recognition and (self-) treatment of reactions and a written treatment plan. The severity of nut allergy was graded (mild-severe) and emergency medication was allocated according to our criteria: all received oral antihistamines, injected adrenaline (EpiPen) was given to those with reactions with airway narrowing, milder reactions to low-dose exposure or concomitant asthma. At annual follow-up over 25 906 patient-months (median: 39 months) retraining was given and details of further reactions (frequency, severity and treatment) were obtained. Criteria for allocation of EpiPen were evaluated. RESULTS: The worst reaction pre-enrolment was mild in 64% and moderate/severe in 36% (airway narrowing). Of 615 subjects followed up, 21% had a further reaction (eightfold reduction in frequency), mostly mild. There was a 60-fold reduction in the frequency of severe reactions. Of those with a moderate-severe initial reaction, 99.5% had no or a less severe follow-up reaction. No child with a mild or severe index reaction had a severe follow-up reaction. Only 1/615 (0.2%) had a severe follow-up reaction and only 2/615 (0.3%) used adrenaline, both successfully and had it available according to our criteria. Of mild-moderate reactions, 77% required oral antihistamines alone and 15% no treatment. Children who had follow-up reactions had more frequent and severe reactions pre-enrolment. CONCLUSION: The management plan greatly reduced the frequency and severity of further reactions and was successful for all children. Our criteria for selective prescription of EpiPen in the context of this management plan were appropriate. This is the first study to provide evidence on which to inform practice.

Administration, Inhalation↗
PubMed1995

Effect of terfenadine and budesonide on nasal symptoms, olfaction, and nasal airway patency following allergen challenge.

The study investigated the effect of the oral H1-blocker terfenadine on allergen challenge in subjects with nasal allergy in comparison with the topical steroid, budesonide. A randomized, placebo-controlled, double-blind, crossover study with 3 experimental days was performed outside the pollen season. Seventeen nonsmokers with hay fever (symptoms, positive skin prick test, and RAST against timothy) were treated for 14 days before each experimental day, where the response to nasal challenge with four different concentrations of timothy was measured every 15 min for 6 h. The nasal cavity dimensions were measured by acoustic rhinometry and the olfactory function as the threshold for the sense of smell of butanol. Nasal symptoms were determined by questionnaires. Both terfenadine and budesonide dry powder had an effect on the hay fever symptoms during nasal pollen challenge. Terfenadine was more efficient than budesonide against histamine-mediated symptoms such as sneezing and itching. Budesonide increased nasal airway dimensions better than terfenadine (P < 0.01). A marked effect of budesonide was seen 1-2 h after challenge, suggesting an effect on "early late phase" reaction in the nose. In 7/17 subjects, a significant (P < 0.05) improvement of olfactory function after budesonide treatment was seen. In conclusion, topical steroid (budesonide) is superior to antihistamine (terfenadine) in treatment of nasal congestion in hay fever, especially for the postchallenge reaction, and may, in some cases, relieve the decreased sense of smell during pollen challenge.

Administration, Inhalation↗
PubMed1996

Once-daily mometasone furoate aqueous nasal spray (Nasonex) in seasonal allergic rhinitis: an active- and placebo-controlled study.

Mometasone furoate aqueous nasal spray (Nasonex) was compared with beclomethasone dipropionate (BDP) aqueous nasal spray in a double-blind, randomized, placebo-controlled, double-dummy, parallel-group study of adults with moderate to severe seasonal allergic rhinitis. Patients allergic to at least one tree and/or grass aeroallergen received one of the following regimens for up to 4 weeks; mometasone furoate 100 micrograms once daily [OD] (n = 126) or 200 micrograms OD (n = 126), BDP 200 micrograms twice daily (n = 126), or only placebo spray (n = 123). Physician-rated nasal and total symptom scores, and global evaluation of overall condition and therapeutic response by physicians and patients, showed that the three active treatments were equally effective, and all three were significantly superior to placebo at most time points. Overall, mometasone furoate 200 micrograms OD demonstrated somewhat greater numerical, but not statistical, superiority to mometasone furoate 100 micrograms OD at the earliest evaluation time point. At the end of treatment, complete or marked relief was obtained in 77% of patients with mometasone furoate 100 micrograms/day, 79% with mometasone furoate 200 micrograms/day, and 74% with BDP, compared with 54% of placebo vehicle control patients. Mometasone furoate and BDP were equally well tolerated. It was concluded that mometasone furoate adequately controls symptoms of moderate to severe seasonal allergic rhinitis, offers the advantage of OD treatment, and is well tolerated.

Administration, Inhalation↗
PubMed2006

Inhaled iloprost in eight heart transplant recipients presenting with post-bypass acute right ventricular dysfunction.

BACKGROUND: During heart transplantation, weaning from cardiopulmonary bypass may be particularly laborious as a result of superimposed acute right ventricular dysfunction in the setting of pre-existing pulmonary hypertension. Research in recent years has focused on inhaled vasodilatory treatment modalities which selectively target the pulmonary circulation. METHODS: We present a series of eight patients in whom inhaled iloprost, a synthetic prostacyclin analog, was used to treat pulmonary hypertension and right ventricular dysfunction detected by transesophageal echocardiography during a heart transplant procedure. In addition to conventional inotropic support, 20 mug of inhaled iloprost was administered via nebulized aerosol for a 20-min period. Complete sets of hemodynamic measurements were obtained before inhalation and during and after cessation of the inhalation period. RESULTS: Inhaled iloprost decreased the transpulmonary gradient at the end of the inhalation period relative to baseline (8.2 +/- 1.6 mmHg vs. 11.2 +/- 0.9 mmHg, P < 0.05). The mean pulmonary artery pressure to systemic artery pressure ratio decreased over this period (0.24 +/- 0.07 vs. 0.44 +/- 0.09, P < 0.05). A statistically significant decrease in the pulmonary vascular resistance to systemic vascular resistance ratio was also observed (0.10 +/- 0.02 vs. 0.19 +/- 0.02, P < 0.05). Improved indices of right ventricular function were observed in echocardiographic monitoring. CONCLUSION: During heart transplantation procedures, episodes of pulmonary hypertension can be successfully treated with inhaled iloprost administration, without untoward side-effects or significant systemic impact.

Administration, Inhalation↗
PubMed1996

Effects of local and systemic budesonide on allergen-induced airway reactions in the pig.

1. In this study, an attempt was made to distinguish between local and systemic effects of low doses of the topical glucocorticoid, budesonide. The effect of aerosolized budesonide administered to the lower airways versus intravenously administered budesonide on the acute and late response to nebulized Ascaris suum extract in the lung, was evaluated in the minipig after active sensitization with purified A. suum antigen. Budesonide was administered once, 1 h prior to A. suum challenge and airway reactions and mediator release were observed for 8 h after allergen challenge. 2. In the budesonide aerosol group (n = 6), 10.2 +/- 1.2 micrograms kg-1 budesonide was given locally and in the budesonide infusion group (n = 5), 5 micrograms kg-1 was given intravenously. The area under the plasma concentration curve for budesonide during the experiment was 11.4 +/- 1.2 and 10.3 +/- 1.2 nM h in the budesonide aerosol and budesonide infusion group, respectively (no significant difference). The lung tissue content of budesonide in the two groups was 45.2 +/- 4.9 and 18.4 +/- 3.5 nmol kg-1 dry tissue, respectively, 8 h after allergen challenge (P < 0.05). For comparison, 6 pigs were given budesonide vehicle as an infusion prior to A. suum challenge. 3. Total lung resistance (RL) increased acutely (maximal response within 15 min) in the budesonide aerosol, budesonide infusion and budesonide vehicle groups (by 91 +/- 40, 150 +/- 86 and 80 +/- 27%, respectively). The acute reaction partially resolved at about 1 h and was followed by a late increase in RL in the budesonide infusion and budesonide vehicle groups (by 251 +/- 148 and 281 +/- 136% at 8 h, respectively). However, no late change in RL was seen in the budesonide aerosol group (7 +/- 24%). 4. Aerosolized budesonide had a protective effect in that it attenuated the late changes in arterial blood gas and pH as well as the late elevation of plasma catecholamines. Budesonide given as an infusion did not protect against the late changes in these parameters. However, budesonide aerosol or infusion did not inhibit the late vasodilation in the bronchial circulation. 5. Histamine and cysteinyl-leukotrienes were released during the acute reaction as measured by urinary concentration of methylhistamine and leukotriene E4 respectively. There was no release of histamine during the late reaction. A late increase in leukotriene E4 was observed in 2 of the budesonide infusion and 3 of the budesonide vehicle pigs, whereas no such increase was seen in any of the budesonide aerosol pigs. 6. Budesonide concentration in lung tissue, but not in plasma at 8 h correlated negatively with the late increase in RL (P < 0.05, r = -0.53, n = 10), whereas budesonide concentration in plasma but not in lung tissue correlated negatively with the late decrease in dynamic compliance (P < 0.05, r = -0.67, n = 12). 7. This study has shown that a single low dose of locally administered budesonide can inhibit the late allergic reaction in the pig lower airways. If budesonide was given as an intravenous infusion in a dose yielding a plasma concentration similar to that seen after the aerosol treatment, the protective effect of budesonide was poor. It may be suggested that the tissue-bound portion of budesonide affects local mechanisms involved in the development of late changes in the airways (RL), although it does not affect the late increase in bronchial blood flow. We conclude that the inhibitory effect of budesonide on the allergen-induced late reaction in the pig airways relates to tissue-bound steroid, and that the systemic component is of less importance.

Administration, Inhalation↗
PubMed2006

Sumatriptan nasal spray in adolescent migraineurs: a randomized, double-blind, placebo-controlled, acute study.

OBJECTIVE: To compare the efficacy and tolerability of sumatriptan nasal spray (NS) (5, 20 mg) versus placebo in the acute treatment of migraine in adolescent subjects. BACKGROUND: Currently, no triptan is approved in the United States for the treatment of migraine in adolescent subjects (12 to 17 years). In a previous randomized, placebo-controlled study of 510 adolescent subjects, sumatriptan NS at 5, 10, and 20 mg doses was well tolerated. However, the primary efficacy analysis for headache relief with 20 mg at 2 hours did not demonstrate statistical significance (P = .059). A second study was initiated to evaluate the efficacy of sumatriptan NS in this population. METHODS: This was a randomized (1:1:1), placebo-controlled, double-blind, parallel-group study. Overall, 738 adolescent subjects (mean age: 14 years) with > or = 6-month history of migraine (with or without aura) self-treated a single attack of moderate or severe migraine. The primary endpoints were headache relief at 1 hour and sustained relief from 1 to 24 hours. Pain-free rates, presence/absence of associated symptoms, headache recurrence, and use of rescue medications were also assessed. Tolerability was based on adverse events (AEs) and vital signs. RESULTS: Sumatriptan NS 20 mg provided greater headache relief than placebo at 30 minutes (42% vs. 33%, respectively; P = .046) and 2 hours (68% vs. 58%; P = .025) postdose, but did not reach statistical significance at 1 hour (61% vs. 52%; P = .087) or for sustained headache relief from 1 to 24 hours (P = .061). Significant differences (P < .05) in favor of sumatriptan NS 20 mg over placebo were observed for several secondary efficacy endpoints including sustained relief from 2 to 24 hours. In general, sumatriptan NS 5 mg percentages were slightly higher than placebo but the differences did not reach statistical significance. Both doses of sumatriptan NS were well tolerated. No AEs were serious or led to study withdrawal. The most common event was taste disturbance (2%, placebo; 19%, sumatriptan NS 5 mg; 25%, sumatriptan NS 20 mg). CONCLUSIONS: This study suggests that sumatriptan may be beneficial to some adolescents and is generally well tolerated in the acute treatment of migraine in this population.

Acute Disease↗
PubMed1992

Evaluation of some prophylactic therapies for the idiopathic headshaker syndrome.

Eighteen horses affected by the idiopathic headshaker syndrome were studied in an owner assessed trial to test the efficacy of some prophylactic therapies. Riding the affected animal with a veil over the nostrils gave varying degrees of temporary relief in three of 10 horses. Local (intra-nasal) corticosteroid therapy was reported to be slightly effective in three of nine horses, but treatment with sodium cromoglycate, systemic corticosteroid, flunixin meglumine and an antihistamine were generally ineffective. Bilateral infraorbital neurectomy provided sustained relief in three of seven horses, but in one of these cases, a reaction at the neurectomy site necessitated another surgical procedure after six months. A fourth horse was reported to be slightly improved after neurectomy. A period of nasal irritation resulting in self-inflicted trauma was a common complication of this surgery.

Administration, Inhalation↗
PubMed1993

Steroid prescribing for asthmatics: relationship with Asthma Symptom Checklist and Living with Asthma Questionnaire.

Psychosocial consequences of asthma were assessed for 42 patients attending an out-patient clinic using the Asthma Symptom Checklist (ASC), a five-dimensional scale of experience during asthma attacks, and the Living with Asthma Questionnaire (LWAQ), a unidimensional scale of experience between attacks. Although all subscales of the ASC and the LWAQ correlated with the physician's prescription of steroids, multiple regression showed that 32 per cent of the prescription decision variance was accounted for by two dimensions of the ASC, panic-fear and irritability. The LWAQ did not explain additional prescription variance, indicating that the physician's decisions were influenced by psychological reactions during asthma attacks rather than between attacks. Prescription decisions were not influenced by clinic-measured respiratory function. The results show some differences with previous studies; implications for patient management are discussed.

Adaptation, Psychological↗
PubMed1994

Prevention of invasive fungal infection during chemotherapy-induced neutropenia in patients with acute leukemia.

This is a retrospective study comparing the methods of preventing fungal infection in a total of 420 episodes of chemotherapy-induced neutropenia of more than 10 days' duration between 1986 and 1992 in 104 patients with acute leukemia and 62 patients who underwent bone marrow transplantation. The episodes were divided into five groups according to the prophylactic regimens (group 1, oral amphotericin B (OA) only; 2, OA and nebulization of amphotericin B (NA); 3, OA and NA with a laminar air flow system (LAF); 4, oral fluconazole (OF) and NA; 5, OF, NA, and LAF. The total numbers of neutropenic episodes were 115, 141, 95, 37, and 32, respectively. A total of 15 episode of invasive fungal infections were documented. Aspergillosis was seen on two occasions each in groups 1 and 2, while none was seen in the patients who were under the LAF system. Nebulization of amphotericin B did not have a significant preventive effect in this study and it needs to be evaluated further by a randomized study.

Acute Disease↗