Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid-dependent, persistent asthma.

BACKGROUND: Inhaled glucocorticosteroids are indicated for the treatment of persistent asthma; however, many young children are unable to effectively use currently available inhalers. OBJECTIVE: We sought to evaluate the efficacy and safety of 3 different twice daily doses of budesonide inhalation suspension (Pulmicort Respules) in inhaled steroid-dependent asthmatic children. METHODS: This was a 12-week, randomized, double-blind, placebo-controlled, parallel-group study involving 178 children (age range, 4 to 8 years) at 17 centers in the United States. Budesonide inhalation suspension doses of 0.25 mg, 0.50 mg, or 1.0 mg twice daily were administered by means of a jet nebulizer and air compressor system. Efficacy was assessed by recording at home nighttime and daytime asthma symptom scores, use of rescue medication, pulmonary function tests, and treatment discontinuation because of worsening symptoms. Safety was assessed by reported adverse events and changes in baseline and adrenocorticotrophic hormone-stimulated plasma cortisol levels in a subset of patients. RESULTS: Baseline demographics, symptom scores, and pulmonary function data were similar across treatment groups. All doses of budesonide inhalation suspension were superior to placebo in improving nighttime and daytime asthma symptom scores (P

Safety and efficacy of azelastine nasal spray (Astelin NS) for seasonal allergic rhinitis: a 4-week comparative multicenter trial.

BACKGROUND: Azelastine is a chemically novel investigational antiallergy drug with the ability to antagonize the effects of chemical mediators of the early- phase and late phase allergic responses suggesting its usefulness in the treatment of upper and lower airway diseases. OBJECTIVE: The objective of this 4-week, double- bind, multicenter trial was to evaluate the efficacy of azelastine nasal spray in subjects with seasonal allergic rhinitis. METHODS: Two hundred sixty-four subjects 12 years of age and older were randomized to receive either azelastine, 2 sprays/nostril qd; azelastine, 2 sprays/nostril bid; oral chlorpheniramine maleate, 12 mg bid; or placebo. The primary efficacy parameters were the changes in major and total symptom severity scores. RESULTS: Overall, across all 4 weeks of treatment, the mean percent improvements in the total and major symptom complex severity scores in both azelastine treatment groups were greater than those for the placebo group. For the azelastine 2 sprays bid group, the overall results were significant at P = .05 for the major symptom complex score and at .05 < P = .10 for the total symptom complex score versus placebo. For both azelastine treatment groups, improvements in all of the individual rhinitis symptoms were superior to those for the placebo group and, in general were clinically and statistically significant. Azelastine nasal spray was well tolerated; adverse experiences were generally application site reactions, mild to moderate, and not limiting to continued treatment. CONCLUSIONS: Azelastine nasal spray demonstrated broad clinical antirhinitis activity that for the 2 sprays/nostril bid dosage regimen was consistently clinically and statistically significant.

Increased use of medical services and antibiotics by children who claim a prior penicillin sensitivity.

On surveying 3,467 children (ages 0 to 19 years) who were members of a health maintenance organization in Spokane, Washington, we found that 95 of 1,497 respondents (6.3%) claimed a past intolerance to penicillin-like agents. We investigated the costs of providing medical care for these 95 children and a random sample of 187 children who did not claim prior penicillin sensitivity. During a two-year period of observation, the children who claimed prior penicillin reactions had a significant increase in the average number of medical visits, the average number of antibiotic prescriptions, the average wholesale cost of antibiotic prescriptions and the average antibiotic cost per patient per month of observation. These children have an increased exposure to antibiotics that may increase their risk for adverse drug reactions.

Etiologic factors in the development of chronic middle ear effusions.

Many factors increase the risk for CMEE in children. We believe the most important include recurrent purulent otitis media, chronic nasal congestion, atopy, and household cigarette smoke exposure. The risk of each of these in causing middle ear disease increases with the chronicity of the exposure. The risk may be additive, with a combination of these factors. CMEE undoubtedly develops through several mechanisms. It is important to look for specific risk factors, as their identification may afford potential approaches toward the prevention of recurrences. Theories such as prophylactic antibiotic administration, pneumococcal vaccination, pharmacologic therapy with antihistamines, decongestants and/or steroids, immunotherapy, and the avoidance of household irritants may be selectively beneficial for the appropriate individual. In an attempt to facilitate strategies to prevent acute middle ear disease as well as recurrent and chronic effusions, further understanding of the etiology, pathogenesis, and risk factors is prerequisite. Additional controlled studies in all of these areas are essential so that we may expand our knowledge base and offer more definitive recommendations to our patients and their families.

A double-blind study comparing the effectiveness of cromolyn sodium and sustained-release theophylline in childhood asthma.

The effectiveness of cromolyn sodium and theophylline on asthma in children was compared during a 3-month trial. Forty-six children (aged 5 to 15 years) with asthma were assigned at random to cromolyn or theophylline (Theo-Dur) treatment groups. Each subject received theophylline placebo or cromolyn placebo in addition to the active drugs. A methacholine challenge test was done at the start of the study to document asthma and was repeated during the third month. The theophylline dosage was regulated to obtain serum levels of 10 to 15 micrograms/mL by a physician not involved directly with patient care. Forty patients completed the study. Both theophylline and cromolyn treatment groups showed improvement from base-line status in terms of symptom scores, pulmonary function, and decreased use of inhaled albuterol. Patients treated with theophylline had more side effects and required more frequent office visits than those treated with cromolyn. Both groups had decreased sensitivity to methacholine, and for one statistical test patients treated with cromolyn improved significantly. These results indicate that cromolyn is as effective as theophylline in treating mild to moderate asthma in children; additional benefits were fewer side effects and a possible decrease in bronchial hyperactivity.

Risk factors for persistent middle-ear effusions. Otitis media, catarrh, cigarette smoke exposure, and atopy.

To ascertain risk factors for persistent middle-ear effusions (PMEE), we interviewed the parents of two groups of children. The first consisted of 76 children with PMEE who were admitted to the hospital for tympanostomy-tube insertion. The second, a control group, consisted of 76 children admitted for other types of surgery, who were matched for age, sex, season, and surgical ward. Nearly all (97%) of the children admitted for insertion of tympanostomy tubes had one or more episodes of suppurative otitis media. Only 59% of the control children had previous ear infections. Frequent ear infections sharply increased the risk for persistent effusions. Catarrh, household cigarette smoke exposure, and atopy also occurred more frequently in children with PMEE. The risk for middle-ear effusions was greatest when these three factors were all present. The avoidance of daily exposure to domestic tobacco smoke and, if atopic, of specific allergens should be included in the medical treatment of children with PMEE.

A generalized allergic reaction with acute interstitial nephritis following trimethoprim-sulfamethoxazole use.

A severe generalized multisystem allergic reaction occurred in a 16-month-old infant following the use of trimethoprim-sulfamethoxazole. Acute interstitial nephritis developed three weeks following the onset of this reaction and resolved after three months. This is the first description of this renal toxicity with TMP-SMX in a child.

Altered theophylline clearance during an influenza B outbreak.

During the 1980 influenza B outbreak in King County, Washington, 11 children whose asthma had previously been controlled with a stable theophylline dose, developed theophylline toxicity on this same dose. Two had seizures, eight had nausea and vomiting, and three had headaches. All had clinical evidence of a febrile viral illness. The toxicity appeared to be related to decreased theophylline clearance, which gradually returned to preillness levels over a period of one to three months. Six of ten children had serologic evidence of influenza B, which is presumed to be the cause of the altered clearance. In children receiving chronic theophylline therapy, symptoms of vomiting, headaches, or seizures during a viral illness may be due to theophylline toxicity rather than the virus. Such patients should have an immediate serum theophylline determination, even if previous levels have been in the therapeutic range.

Race-related differences in peripheral blood and in bone marrow cell populations of American black and American white infants.

The present study confirms that in healthy infants, a racial difference exists in peripheral blood hemoglobin levels, total leukocyte, and total neutrophil counts. Racial differences in the composition of the bone marrow are negligible. The only demonstrable difference is confined to the erythroid cell population. No significant difference exists in the incidence of myeloid cells or small lymphocytes.