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Biomedical subjects

G S Rachelefsky

Publications and source records attributed to G S Rachelefsky.

At least 19 recordsLinked to original sources
PubMed2000

Detection of growth suppression in children during treatment with intranasal beclomethasone dipropionate.

OBJECTIVE: Intranasal beclomethasone dipropionate (BDP) has generally been considered to have no systemic activity at recommended doses, but the potential for long-term effects on growth has not previously been evaluated. This study was undertaken to assess the effects of 1 year of treatment with intranasal BDP on growth in children. STUDY DESIGN: In this double-blind, randomized, parallel-group study, 100 prepubertal children 6 to 9 years old with perennial allergic rhinitis were treated with aqueous BDP 168 microg twice daily (n = 51) or placebo (n = 49) for 1 year. Subjects' baseline heights were required to be between the 5th and 95th percentile, and skeletal age as determined by left wrist radiograph was required to be within 2 years of chronological age. Washout periods for medications known to affect growth, including other forms of corticosteroids, were established, and these medications were prohibited during the study. However, short courses of oral prednisolone lasting no more than 7 days, and short courses of dermatologic corticosteroids lasting no more than 10 days, were allowed. Height was measured with a stadiometer after 1, 2, 4, 6, 8, 10, and 12 months of treatment. The hypothalamic-pituitary-adrenocortical axis was assessed by measurements of 8 AM basal cortisol concentrations and response to. 25 mg cosyntropin stimulation. The primary safety parameter was the rate of change in standing height. Statistical analyses were based on all randomized subjects who received at least 1 dose of medication (intent-to-treat principle). The rate of change in standing height was analyzed for all subjects who entered the study and for those completing the full 12 months of treatment (n = 80). The rate of change in standing height over the 1-year study was calculated as the slope of a linear regression line fitted to each subject's height measurements over time. Because there was a statistically significant between-group difference in standing height at baseline, an analysis of covariance was performed for all analyses of standing height data. RESULTS: Of the 100 subjects enrolled, 90 completed the study. The 2 treatment groups were generally comparable at baseline; however, at baseline, mean age and mean height were significantly greater in the BDP treatment group that the in placebo treatment group. In both analyses, overall growth rate was significantly slower in BDP-treated subjects than placebo-treated subjects. The mean change in standing height after 1 year was 5.0 cm in the BDP-treated subjects compared with 5.9 cm in the placebo-treated subjects. The difference in growth rates was evident as early as the 1-month treatment visit, suggesting that the effect on growth occurred initially. The growth-suppressive effect of BDP remained consistent across all age and gender subgroups, and among subjects with and without a previous history of corticosteroid use. Use of additional exogenous corticosteroids during the study was similar in both groups and did not affect the results. Because there was a baseline imbalance in height, a supplemental analysis of the differences in prestudy growth rates was performed. This analysis found no baseline imbalance in prestudy growth rates. To determine whether the difference in growth rates during the study could be attributed to preexisting growth rates, a z score analysis was performed. The heights of both groups were normalized at baseline and at the end of the study using the US National Center for Health Statistics data for mean and standard deviations of height. This analysis confirmed that the difference in growth rates between the 2 groups was primarily attributable to the treatment rather than to any preexisting difference in growth. Additional analyses confirmed that the results were not influenced by outlier values. No significant between-group difference were found in the hypothalamic-pituitary-adrenocortical axis assessments. No unusual adverse events were observed. (ABSTRACT

Administration, Intranasal↗
PubMed1999

National guidelines needed to manage rhinitis and prevent complications.

OBJECTIVES: Rhinitis is an extremely common disease worldwide and nasal allergies are one of the major causes of the condition. Allergic rhinitis not only produces a range of nasal and non-nasal symptoms, but it has been closely associated with other chronic airways diseases, such as asthma and sinusitis. This review was undertaken to evaluate the relationship of allergic rhinitis to these diseases and to provide support for proposing national guidelines for managing rhinitis. DATA SOURCES: Relevant studies in English were searched for using MEDLINE, bibliographies from obtained articles, and consultation with experts. STUDY SELECTION: All major studies related to the epidemiology and effects of allergic rhinitis and the relationship between allergic rhinitis and asthma, sinusitis, and other airways diseases were reviewed. DATA SYNTHESIS: There is substantial scientific and clinical evidence that allergic rhinitis frequently coexists with asthma, and sinusitis and may be a predisposing factor for both. In addition, a number of studies have demonstrated that nasal inflammation and obstruction directly affect pulmonary function and clinical symptoms of asthma. Finally, it has been clearly demonstrated that treating allergic rhinitis with antihistamines, nasal corticosteroids, immunotherapy, and allergen avoidance have a significant, positive effect on lung function and asthma symptomology. CONCLUSIONS: The prevalence of allergic rhinitis, asthma, and sinusitis are increasing. Asthma and sinusitis can be debilitating conditions. Asthma alone can be life threatening and costly to treat. The timely and optimal treatment of allergic rhinitis may help prevent these conditions or, at least, prevent them from worsening. Consequently, there is an immediate need to establish national, evidence-based, practice guidelines to assist primary care physicians in diagnosing and managing rhinitis and in evaluating and managing rhinitis and in evaluating and managing allergic rhinitis coexisting with other airways diseases.

Adult↗
PubMed1997

The effectiveness of once-daily dosing of inhaled flunisolide in maintaining asthma control.

OBJECTIVE: The purpose of this study was to evaluate the feasibility of switching to once-daily (qd) administration of flunisolide in patients with asthma that was controlled by twice-daily (bid) dosing of this inhaled steroid. METHODS: Three hundred sixty-six adults and children with bronchial asthma that was controlled with inhaled steroids were recruited for this prospective, double-blind, parallel-group study. After a 4-week, stable baseline period of flunisolide administration, 2 inhalations (500 microg) twice daily, each patient was randomized into one of four 12-week flunisolide treatment groups: group 1, 2 inhalations (500 microg) bid; group 2, 4 inhalations (1000 microg) qd in the morning; group 3, 4 inhalations (1000 microg) qd in the evening; or group 4, 2 inhalations (500 microg) qd in the morning. Outcome measures included morning and evening asthma symptoms (scale of 0 to 3), daytime and nighttime albuterol use, morning and evening peak expiratory flow rate (PEFR), FEV1, and methacholine PC20. In addition, a subset of patients in each group had 24-hour urinary cortisol levels measured before and after randomization. RESULTS: Outcome measures in the four groups were not significantly different at baseline before randomization. The three groups that received maintenance therapy with flunisolide, 1000 microg daily, did not show significant changes from baseline values and remained comparable in all outcome areas. Asthma control in the group randomized to flunisolide 500 microg qd, however, deteriorated significantly: morning symptoms increased by 0.21 units (48%), evening symptoms increased by 0.15 units (31%), daytime albuterol use increased by 0.42 inhalations per day (37%), nighttime albuterol use increased by 0.48 inhalations per night (91%), morning PEFR decreased by 17.1 L/min (4%), and evening PEFR decreased by 12.6 L/min (3%). There were no significant changes in PC20 or 24-hour urinary cortisol levels in any group. CONCLUSIONS: For patients with asthma that was stabilized by 2 inhalations of flunisolide (500 microg) bid, switching to 4 inhalations (1000 microg) qd in either the morning or evening is effective in maintaining asthma control. Reducing the dose to 2 inhalations (500 microg) qd in the morning, however, leads to a deterioration in asthma control.

Administration, Inhalation↗
PubMed1997

Improvement of bronchial hyperresponsiveness in asthmatic children treated for concomitant sinusitis.

BACKGROUND: There appears to be an association between sinusitis and asthma. The effect on bronchial hyperresponsiveness of clinical therapy for sinusitis in children may help to decipher whether sinusitis and asthma are independent manifestations of the same disease. OBJECTIVE: To evaluate the effect of clinical treatment for sinusitis in patients with rhinitis and/or asthma on symptoms and on bronchial hyperresponsiveness to methacholine. METHODS: Open label, randomized, non-treatment control in a teaching hospital in São Paulo, Brazil. Forty-six atopic and 20 normal children were studied. The atopic children consisted of 18 with allergic rhinitis (12 without sinusitis and 6 with sinusitis), and 28 children with rhinitis with asthma (13 with normal sinus radiographs and 15 with complete opacification of the maxillary sinuses). Methacholine PC20 was determined before and 30 days after treatment with nasal saline, sulfamethoxazole-trimethoprim, antihistamine/decongestant, and five days of prednisone. Sinus radiographs were also repeated. RESULTS: The only patients with increase in methacholine PC20 were patients with rhinitis and asthma with opacified maxillary sinuses at entry and who at 30 days had normal sinus radiographs (P < .05). CONCLUSION: In this study, children with allergic rhinitis and sinusitis with asthma improved their bronchial hyperresponsiveness to methacholine and decreased their symptoms with appropriate response of their sinuses to clinical therapy.

Administration, Intranasal↗
PubMed1995

Helping patients live with asthma.

Few patients with asthma receive sufficient basic training in routine self-care. Even young children can learn to keep track of their symptoms, use a peak flow meter, and recognize when bronchodilator and anti-inflammatory drug dosages must be stepped up. Moreover, more than half of patients have chronic inflammatory airway disease, yet most of them are not being treated for the inflammatory component of their disorder.

Acute Disease↗
PubMed1995

Comparison of the bronchodilatory effects of cetirizine, albuterol, and both together versus placebo in patients with mild-to-moderate asthma.

BACKGROUND: Many potential users of the H1 antihistamine cetirizine are asthmatic and may be using inhaled albuterol. This study was conducted to assess the possible bronchodilatory effect of cetirizine in patients with mild-to-moderate asthma and to determine whether cetirizine interacts with albuterol. METHODS: In a randomized, double-blind, placebo-controlled, crossover study, the effects on pulmonary function of 5, 10, and 20 mg oral doses of cetirizine with and without inhaled albuterol (180 micrograms) were determined in 12 patients at 11 time points over 8 hours. The primary measure of efficacy was forced expiratory volume in 1 second (FEV1). RESULTS: Cetirizine with or without albuterol significantly increased FEV1, peak expiratory flow rate, and forced expiratory flow rate between 25% and 75% of vital capacity relative to baseline and placebo but did not have a significant effect on forced vital capacity. The effect of 20 mg of cetirizine on FEV1 was generally greater than that of 10 or 5 mg, but the difference was statistically significant only at the 30-minute time point (p < 0.05). All three cetirizine doses produced significantly greater increases than placebo in FEV1 and forced expiratory flow rate between 25% and 75% of vital capacity for 8 hours and in peak expiratory flow rate for 7 hours (p < 0.02). Albuterol alone had a significant effect on the four pulmonary function variables from 1 to 5 hours after baseline (p < 0.05), which is consistent with albuterol's recommended dosing frequency of every 4 to 6 hours. Albuterol alone increased FEV1 significantly more than 5 mg of cetirizine alone but not 10 mg or 20 mg of cetirizine alone at 60, 90, and 120 minutes after baseline, but all three doses of cetirizine increased FEV1 significantly more than albuterol 7 and 8 hours after baseline (p < 0.05), indicating that the bronchodilatory action of cetirizine lasts longer than that of albuterol. Cetirizine neither potentiated nor inhibited the bronchodilatory action of albuterol, but the two drugs appeared to have an additive bronchodilatory effect. None of the cetirizine treatments caused a worsening of pulmonary function, and all were well tolerated. CONCLUSIONS: Cetirizine has a significant bronchodilatory effect in patients with mild-to-moderate asthma and can be used to treat concomitant conditions (e.g., allergic rhinitis) without concern that it will interfere with the bronchodilatory effect of albuterol or cause worsening of asthma by itself.

Albuterol↗
PubMed1992

The inflammatory response in asthma.

Asthma is remarkably underdiagnosed and undertreated. While the clinical hallmark of asthma is reversible airflow obstruction, airway inflammation is the major pathologic feature. Studies have linked airway hyperresponsiveness, the basic physiologic defect in asthma, with airway inflammation, even in patients who have mild asthma. Management is directed toward treating the underlying disease process with anti-inflammatory therapy and alleviating breakthrough symptoms with bronchodilators.

Anti-Inflammatory Agents↗
PubMed1991

Compliance in clinical trials of two nonbronchodilator, antiasthma medications.

An electronic monitoring device was used to assess patient compliance during clinical trials of two new aerosolized nonbronchodilator, antiasthma drugs. Compliance was poor, but similar, in both trials. Patients took the study drug as instructed on a mean of 37.3% days (range 10% to 77%) in one trial and 37.4% days (range 0% to 63%) in the other. Both underuse and overuse were observed. Underuse was seen on a mean of 38.9% days (range 9% to 81%) and 46.0% (range 15% to 80%) respectively; overuse on a mean of 23.5% days (range 6% to 54%) and 16.6% days (range 0% to 41%). In some patients ten or more activations of the device were recorded at the same time. In six patients such multiple simultaneous activations were recorded on two or more separate days. These patients were among the most noncompliant in the study. Multiple simultaneous activations frequently followed underuse days or preceded followup visits, suggesting the possibility of duplicity. Overall compliance was such that valid conclusions about efficacy of the drugs could only have been drawn in six of 34 patients.

Administration, Inhalation↗
PubMed1990

The microbiology of chronic sinus disease in children with respiratory allergy.

Chronic maxillary sinusitis is common in children with respiratory allergy and is associated with increased morbidity. The bacteriology of chronic sinus disease in these children has not been adequately evaluated. Between May 1987 and January 1988, 12 children (aged 3 to 9 years), all with documented respiratory allergy and chronic respiratory symptoms consistent with chronic sinusitis (greater than 30 days), were fully evaluated. History, physical examination, complete blood count, nasal smear, and Waters x-ray were done. All patients had opacification of one or both maxillary sinuses, failed to respond to multiple courses of antibiotics, and subsequently underwent maxillary sinus aspiration and irrigation. Specimens were cultured for aerobic and anaerobic organisms with standard technique, and sensitivities were obtained. Culture results revealed a single organism (Moraxella [Branhamella] catarrhalis) in five patients, one patient yielded M. catarrhalis plus Streptococcus species, three were negative, and three patients grew multiple organisms (two with multiple aerobic streptococcal species and one patient with aerobic streptococci and Peptostreptococcus). All children received appropriate culture-directed antimicrobial therapy. Sequential biweekly follow-up revealed progressive radiographic clearing and significant symptomatic improvement. M. catarrhalis is a common pathogen, whereas anaerobic organisms are unusual as a cause of chronic maxillary sinusitis in allergic children. Some children, despite negative cultures, may benefit from maxillary sinus irrigation.

Child↗