OBJECTIVE:To compare the efficacy and safety of once-daily inhaled ciclesonide 40 mug (CIC40), 80 mug (CIC80), and 160 mug (CIC160) with placebo in children with persistent asthma of all severities. STUDY DESIGN:Overall, 1031 children age 4 to 11 years were randomized into 2 identical double-blinded, placebo-controlled, parallel group studies consisting of a run-in phase followed by 12 weeks of treatment. Both studies were designed to allow for a prespecified integrated analysis. The primary outcome variable was change in forced expiratory volume in 1 second (FEV(1)) percent predicted between baseline and study end; treatment comparisons were assessed using analysis of covariance. Additional endpoints included asthma symptom scores, daily albuterol use, and safety, including hypothalamic-pituitary-adrenal (HPA) axis function. RESULTS:Baseline characteristics were comparable; 59.4% of patients had moderate asthma, and 24.1% had severe asthma. All ciclesonide doses were associated with greater improvements in baseline to week 12 FEV(1) percent predicted versus placebo (CIC40, 11.97; CIC80, 13.58, P <.05; CIC160, 14.17, P < .01). Significant improvements in asthma symptoms (P < .01) and reductions in albuterol use were reported. Ciclesonide was well tolerated with no effect on HPA axis function. CONCLUSIONS:In this integrated analysis, ciclesonide was effective and well tolerated in children with persistent asthma.
Georgitis, John W.; Galant, Stanley; Lloyd, Mark; Kundu, Sudeep; Fish, James E.; Banerji, Donald; Hamedani, Parvez Author Information
Gastroesophageal reflux is considered one of the etiologies for chronic respiratory and laryngeal symptoms in infants and children, yet the association has been difficult to prove. Dual-channel 24-hour pH probe studies have become more common in the evaluation of these children. To establish whether a significant correlation exists between pharyngeal acid exposure and chronic respiratory symptoms in children, 293 infants and children with and without respiratory symptoms underwent 24-hour double pH probe monitoring. Patients were divided into four groups based on the clinical indication for the study and the results of the distal sensor. Pharyngeal reflux episodes correlated positively (r = 0.54) with lower esophageal episodes but did not differentiate children with respiratory symptoms from those with nonrespiratory symptoms. There was an inverse relation between the number of pharyngeal reflux episodes (r = -0.14) and age, making the definition of abnormal pharyngeal reflux age dependent. The evaluation for pharyngeal acid does not supplant or replace studies of the distal esophagus in children with chronic respiratory symptoms. In addition, the mechanism for acid-induced respiratory symptoms in children requires more intensive investigation than a pH probe study.
Vaccines have had a dramatic effect on the prevalence of communicable diseases, but, in selected individuals, the injection presents a risk of anaphylaxis. Fortunately, most people have no allergic reactions to vaccines. In egg-allergic individuals, care must be taken before administering specific vaccines; the algorithm provided in this article gives specific recommendations for skin testing and desensitization. This algorithm is not needed for individuals receiving the measles-mumps-rubella vaccine because the risk of anaphylaxis is extremely low, even in those with known egg-protein sensitivity. Some individuals have gelatin sensitivity, which may cause anaphylaxis. Selected vaccines contain antibiotic drugs, so it is important to note if an individual has any known drug sensitivity, especially to neomycin, polymyxin B, or amphotericin B. Lastly, vaccine preservatives may cause reactions, but this occurs very infrequently.
Inhaled corticosteroids are commonly prescribed as first order treatment for children with asthma because of their potent and long-term effectiveness on airway inflammation. The success of treatment is traditionally measured via pulmonary function, specifically forced expiratory volume in one second (FEV1). However, exercise intolerance is a common complaint of children with asthma and may not be reflected by resting pulmonary measures. The purpose of this study was to compare exercise tolerance between asthmatic children treated with inhaled corticosteroid therapy (ICT) and those who are not (NO ICT). The subjects consisted of 19 asthmatic children, 10 ICT (5M, 5F) and 9 NO ICT (4M, 5F). Mean age was 11.95 ± 2.72 years with a range of 7 to 15 years. Physical work capacity (PWC) was determined from a progressive maximal exercise test on a cycle ergometer. Pulmonary function (including FEV1) was assessed via standard spirometry. Past year physical activity was measured via the Modifiable Activity Questionnaire, and physical inactivity was determined from the total number of hours per week engaged in sedentary behaviors (watching TV, listening to music, using computer, doing homework, and reading). Independent t-tests were used to compare dependent measures between ICT and NO ICT groups. Multiple regression analysis was used to determine the independent predictors of PWC. Mean FEV1 % of predicted did not differ significantly between the ICT (96 ± 6%) and NO ICT (100 ± 18%) groups. PWC, however, was significantly greater in the ICT (110 ± 14% of predicted) than NO ICT group (93 ± 17% of predicted). Average weekly physical activity for the past year was also not different between ICT and NO ICT groups (13.6 ± 9.9 v. 12.4 ± 14.2 hrs/wk). ICT subjects engaged in fewer hours of sedentary activities than NO ICT subjects (21.3 ± 11.9 v. 27.8 ± 9.7 hrs/wk, respectively). Multiple regression analysis indicated that ICT, FEV1 % predicted, and physical inactivity were significant independent predictors of PWC % predicted, explaining 62% of its variance while adjusting for age, sex, and past year physical activity. These preliminary findings suggest that asthmatic patients on ICT have better exercise capacity and tend to be less sendentary than patients not taking ICT, despite similar pulmonary function. Supported in part by the Wake Forest University Cross-Campus Fund.
This study is a retrospective analysis comparing nebulized budesonide inhalation suspension (BIS; Pulmicort Respules™, AstraZeneca, Wilmington, DE) administered once daily by facemask or mouthpiece in 359 infants and young children with persistent asthma. The efficacy and safety of once-daily BIS (0.25, 0.5, and 1.0 mg) administered by facemask or mouthpiece were demonstrated in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study reported by Kemp et al. (Ann Allergy Asthma Immunol 1999; 83:231–239). Three hundred fifty-nine children aged 6 months to 8 years with mild, persistent asthma received nebulized BIS 0.25, 0.5, or 1.0 mg once daily or placebo for 12 weeks via facemask or mouthpiece. Efficacy variables included nighttime and daytime asthma symptom scores, use of breakthrough bronchodilator medications, and pulmonary function tests (in children capable of consistently performing spirometry or peak flows). Changes in nighttime and daytime asthma symptom scores were not significantly different between children using facemasks and those using mouthpieces. Use of breakthrough medications and pulmonary function test results (in the subset of children able to perform them) also were not significantly different in facemask users and mouthpiece users. These results suggest that BIS is equally effective whether administered by facemask or mouthpiece and that young children who require the use of a facemask may be successfully treated.
Background: Medications containing a combination antihistamine-decongestant are commonly used for allergic rhinitis yet onset-of-action comparisons for symptom relief after a single dose have not been performed.Objective: To determine the onset of symptom relief and efficacy of antihistamine-decongestant medications (acrivastine-pseudoephedrine and loratadine-pseudoephedrine) compared with placebo in an outdoor park.Methods: This study was conducted during the spring of 1997 using a double-blind, placebo-controlled design. Patients completed baseline rhinitis symptom diaries from 7:30 to 9:30 AM. Subjects with qualifying symptom scores received one dose of either acrivastine-pseudoephedrine, loratadine-pseudoephedrine, or placebo at 10:00 AM. Symptom diaries were recorded for the next 4 hours.Results: Of 593 patients randomized to treatment, 592 were included in efficacy analysis. Acrivastine-pseudoephedrine and loratadine-pseudoephedrine demonstrated a mean onset-of-action by 45 and 30 minutes respectively for total symptom and rhinitis symptom scores for the five sites. Onset-of-action for nasal congestion scores was 45 minutes for both medications. Sites having higher pollen exposure (>100 pollen grains over 6 hours) demonstrated a difference between the antihistamine combinations: acrivastine-pseudoephedrine had an onset of action at 45 minutes for total symptom and rhinitis symptom scores, and 15 minutes for nasal congestion scores whereas loratadine-pseudoephedrine had onset-of-action for nasal congestion score of 105 minutes but failed to reach significance at any timepoint for total symptom and rhinitis symptom scores.Conclusions: Both antihistamine-decongestant combinations demonstrate an onset-of-action within 60 minutes of administration but under conditions of higher pollen exposure, the acrivastine combination was more effective for total symptoms, rhinitis symptoms, and nasal congestion with an onset-of-action within 45 minutes for rhinitis symptoms and 15 minutes for congestion.
Glomerulonephritis (GN) associated with pneumonia is rare and has to be differentiated from preexisting and etiologically unrelated conditions. Acute postinfectious glomerulonephritis (APGN) classically presents after a 2- to 3-week interval after pharyngitis or impetigo caused by group A β-hemolytic streptococci with a peak in preschool and early school-age years. 1 Cole BR Salinas-Madrigal L Acute proliferative glomerulonephritis and cresentic glomerulonephritis. in: ed 3. Pediatric Nephrology. Williams & Wilkins, Baltimore, MD1994: 697-718 Google Scholar , 2 Silva FG Acute postinfectious glomerulonephritis and glomerulonephritis complicating persistent bacterial infection. in: Heptinstall's Pathology of the Kidney. vol 1. Lippincott-Raven, Philadelphia, PA1998: 389-453 Google Scholar The causal relationship between non-streptococcal infections and acute glomerulonephritis is not well defined. 2 Silva FG Acute postinfectious glomerulonephritis and glomerulonephritis complicating persistent bacterial infection. in: Heptinstall's Pathology of the Kidney. vol 1. Lippincott-Raven, Philadelphia, PA1998: 389-453 Google Scholar Conversely, infections, predominantly of the respiratory tract, can precede the onset or recurrence of membranoproliferative glomerulonephritis (MPGN), immunoglobulin A (IgA) nephropathy and Schönlein-Henoch purpura, and other glomerulonephritides, such as Wegener's granulomatosis and Goodpasture's syndrome, 3 Kobrin S Madaio MP Acute poststreptococcal glomerulonephritis and other bacterial infection-related glomerulonephritides. in: ed 6. Diseases of the Kidney. vol II. Little, Brown, Boston, MA1997: 1579-1593 Google Scholar , 4 Mandell BF Calabrese LH Infections and systemic vasculitis. Curr Opin Rheumatol. 1998; 10: 51-57 Crossref PubMed Scopus (92) Google Scholar , 5 Mayet WJ Marker-Hermann E Schlaak J Meyer zum Büschenfelde KH Irregular cytokine pattern of CD4+ T lymphocytes in response to Staphylococcus aureus in patients with Wegener's granulomatosis. Scand J Immunol. 1999; 49: 585-594 Crossref PubMed Scopus (39) Google Scholar dictating the need for a histological diagnosis except in young children with APGN and established streptococcal origin. We discuss a case of a teenage boy with Staphylococcus aureus pneumonia, who developed hyponatremia and hypertension, followed by an acute nephritic-nephrotic syndrome with renal failure.
Background: Hypersensitivity to deer dander is rarely reported, with only 26 cases in the literature. Ours is the youngest reported case and the first reported case of anaphylaxis on exposure to a live deer.Objective: Evaluation of a case of anaphylaxis in a young boy upon exposure to a deer.Methods and Results: A 4-year-old boy experienced hives, swelling, and shortness of breath requiring epinephrine following a deer exposure. He had one mild reaction 5 days prior to his anaphylaxis with an indirect exposure. A deer dander extract was made from fur supplied by the patient's mother. IgE-mediated reactivity was positive for deer and cattle by both selective skin prick method and RAST results.Conclusion: Hypersensitivity to wild animals can lead to life threatening anaphylaxis, even in children. Passive transfer of antigen may occur, but needs further investigation.
The eyes are described by poets as being the windows to the soul. If that is so, then the nasal cavity is the window to the body. The nose is a highly accessible tool for observing the intricate details of the human immunological and vascular systems, especially as they relate to chronic rhinitis conditions. By examining the nasal mucosa and collecting secretions, the clinician or researcher can investigate normal physiological conditions and the allergic elements: the early phase, late phase, and chronic response. There are numerous methods developed to characterize and quantify nasal responses. The clinician can use some of these techniques whereas others are intended only for research purposes. This chapter will review three common procedures used in the evaluation of allergen-induced changes inEach of these procedures is easily tolerated by the patient and can be performed in either the of ce or laboratory setting. Invaluable objective information is obtained regarding improvement and modi cation of the underlying in ammatory process. Each of these procedures will be reviewed, along with indications for the test, a discussion of the technique, and expected responses forpatients with and without nasal disease.II. NASAL SMEAR A. Introduction Allergic rhinitis symptoms are an indirect response to mediators produced by activated in ammatory cells residing within the nasal mucosa and submucosa. In the allergic response, allergens bind to surface-bound IgE antibodies, resulting in mast cell activation. Cellular activation causes immediate release and subsequent production of in ammatory mediators such as histamine, platelet activating factor, leukotrienes, and prostaglandins. These mediators in turn cause an acute in ammatory reaction called the early allergic response. Both preformed and newly produced mediators promote the recruitment to the site of additional in-ammatory cells (eosinophils, neutrophils, basophils and lymphocytes). These cells continue the in ammatory process as the late phase response. The eosinophil is the primary in ammatory cell identi ed in allergic rhinitis, but lymphocytes, neutrophils, mast cells, and basophils are also present. Accurate identi cation of these cells assists the physician in correctly diagnosing the condition and selecting appropriate therapy. In the research setting, techniques for evaluating cellular components of nasal secretions give further insight into the pathogenesis and pathophysiology of allergic and nonallergic rhinitis. The nasal smear provides one means of identifying in ammatory cells in the nasal mucosa and the secretions. The Hansel stain, described by F. K. Hansel in 1953, is a rapid, easily performed technique used to identify the primary cellular components of nasal secretions (1). Over time, other diagnostic methods have been developed. This section will discuss nasal sampling techniques, staining techniques, cell evaluation, the clinical relevance of the diagnostic ndings, and the expected changes with therapy.
Objective To compare the safety and efficacy of ipratropium bromide 0.03% (IB) with beclomethasone dipropionate 0.042% (BDP) in the treatment of perennial rhinitis in children. Methods Thirty-three children with nonallergic perennial rhinitis (NAPR) and 113 with allergic perennial rhinitis (APR) were randomly assigned to either IB or BDP for 6 months in a single-blind, multicenter protocol in which the physician was blinded to treatment. At each visit, patients and physicians rated symptom control of rhinorrhea, nasal congestion, and sneezing. Patients also completed quality of life questionnaires at baseline and after 6 months of therapy. Results Both treatments showed a significant improvement in control of rhinorrhea, congestion, and sneezing compared with baseline over the 6 months of treatment (P < .05). Only for the control of sneezing was BDP consistently better than IB (P < .05). Among the patients given IB, 61% to 73% assessed the control of rhinorrhea as good or excellent on different study visit days, 43% to 60% similarly rated the control of nasal congestion, and 39% to 43% the control of sneezing. The results for BDP were 68% to 78% for the control of rhinorrhea, 55% to 72% for the control of nasal congestion, and 54% to 68% for the control of sneezing. Quality of life assessment documented that both drugs significantly reduced interference with daily activities and disturbance of mood due to rhinorrhea compared with baseline (P < .05). Both treatments were well tolerated with IB causing less nasal bleeding and irritation than BDP. Conclusions Ipratropium bromide was safe and effective in controlling rhinorrhea and diminishing the interference by rhinorrhea in school attendance, concentration on school work, and sleep. Ipratropium bromide was as effective as BDP in the control of rhinorrhea and showed a relatively good effect on congestion. Patient and physician assessment favored BDP in the control of sneezing.
In 1997, the National Heart, Lung, and Blood Institute released the Second Expert Panel Report on the Guidelines for the Diagnosis and Management of Asthma as a follow-up to the first report issued in 1991. Implementation of the recommendations from this report could have a potentially huge impact on care and treatment of asthma in the United States. Even though the Guidelines are expansive, there are some areas related to the pharmacologic component that warrant further discussion and clarification. These are: (1) safety and efficacy of available asthma medications, (2) clinical efficacy comparisons of inhaled corticosteroids, (3) comparative risks among inhaled corticosteroids, and (4) expectations of different delivery systems used with inhaled corticosteroids.
The objective of this study was to compare the efficacy and safety of Claritin-D 24 Hour (once daily) with that of Claritin-D 12 Hour (twice daily) and placebo in the treatment of patients with seasonal allergic rhinitis (SAR). In this double-blind, placebo-controlled, multicenter study, 469 patients with moderate-to-severe SAR symptoms were treated for 2 weeks with one of the following: Claritin-D 24 Hour (a combination tablet formulation of loratadine 10 mg in the coating and pseudoephedrine sulfate 240 mg in an extended-release core), Claritin-D 12 Hour (a combination tablet formulation of loratadine 5 mg in the tablet coating and 120 mg pseudoephedrine sulfate, 60 mg in the coating and 60 mg in the core), or placebo. Claritin-D 24 Hour and Claritin-D 12 Hour were consistently superior to placebo (P < 0.01) in reducing total, nasal, and nonnasal symptom scores. Patients in the Claritin-D 24 Hour and Claritin-D 12 Hour groups also had significantly greater (P lE 0.05) relief of rhinorrhea and nasal stuffiness as compared with placebo. Insomnia was reported significantly more often (P < 0.01) in Claritin-D 12 Hour (15%) patients compared with Claritin-D 24 Hour (4%) and placebo (2%) patients. Dry mouth was reported significantly more often (P < 0.05) in Claritin-D 24 Hour (13%) and Claritin-D 12 Hour (13%) groups compared with placebo (4%). Claritin-D 24 Hour has efficacy comparable to Claritin-D 12 Hour in relieving allergic rhinitis symptoms while producing significantly less insomnia.
Journal of Pediatric Gastroenterology and NutritionVolume 27, Issue 4 p. 476-476 Annual Meeting of the North American Society for Pediatric Gastroenterology and Nutrition; Orlando, October 22–24, 1998 DUAL CHANNEL pH PROBE IS NOT DISTINCTIVE IN CHILDREN WITH GERD & RESPIRATORY SYMPTOMS (RS) M Glock, M Glock Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this authorC Woods, C Woods Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this authorC Del Toro, C Del Toro Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this authorJ Georgitis, J Georgitis Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this authorI Hill, I Hill Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this author M Glock, M Glock Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this authorC Woods, C Woods Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this authorC Del Toro, C Del Toro Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this authorJ Georgitis, J Georgitis Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this authorI Hill, I Hill Wake Forest Univ. Sch. of Med., Winston-Salem, NCSearch for more papers by this author First published: 01 October 1998 https://doi.org/10.1002/j.1536-4801.1998.tb01378.xRead the full textAbout ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume27, Issue4October 1998Pages 476-476 RelatedInformation
BACKGROUNDAnticholinergic agents, specifically the quaternary salt of atropine, are currently being recommended for chronic rhinitis and the common cold.OBJECTIVETo evaluate the efficacy and safety of 50- and 75-microg doses of atropine sulfate as a nasal spray in perennial allergic rhinitis.METHODSA placebo-controlled, double-blind study compared 2 doses of atropine nasal spray given 4 times daily for 2 weeks to 45 patients with perennial allergic rhinitis after a 2-week baseline period.RESULTSBoth concentrations of atropine nasal spray improved the severity of rhinorrhea and postnasal drip (P<.001) as reported by patients and physicians. The duration of action in reducing rhinorrhea and postnasal drip for atropine was 2 to 3 hours, compared with less than 1 hour for placebo (P<.01). No difference was noted in efficacy between the 2 atropine doses nor in frequency of adverse events with atropine nasal spray and placebo.CONCLUSIONSAtropine sulfate, 50 or 75 microg 4 times daily, is effective in reducing rhinorrhea and postnasal drip within 2 weeks and may be an alternative therapy for the rhinorrhea component of rhinitis.