The Journal of asthma : official journal of the Association for the Care of Asthma
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Randomized Controlled Trial Multicenter Study Clinical Trial
Fenoterol delivery by Respimat soft mist inhaler versus CFC metered dose inhaler: cumulative dose-response study in asthma patients.
Respimat (RMT) soft mist inhaler (SMI) is a novel, propellant-free alternative to chlorofluorocarbon metered-dose inhalers (CFC-MDIs). The aim of this study was to evaluate the safety and establish the equipotent dose of fenoterol delivered by RMT SMI vs. a conventional MDI. ⋯ The bronchodilator response (forced expiratory volume in 1 second [FEV1]) was considered therapeutically equivalent (i.e., noninferior) if the 95% confidence intervals for the difference in their mean changes from baseline were within limits of +/- 0.15L. Systemic exposure was evaluated from plasma fenoterol levels. Adverse events (AEs) were recorded. RMT50 and RMT100 produced noninferior bronchodilatation to MDI100 from 30minutes after the first dose. RMT50 showed equivalent safety and tolerability to MDI100, whereas RMT100 produced a higher incidence of AEs, a significantly greater plasma potassium reduction and a significant increase in pulse rate. Fenoterol plasma levels were twice as high with RMT100 as with RMT50 or MDI100. CONCLUSIONS; The nominal dose of fenoterol administered via RMT SMI can be at least halved to achieve equivalent efficacy, safety, and tolerability to a MDI.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Evaluation of parental preference for the treatment of asthmatic children aged 6 to 11 years with oral montelukast or inhaled cromolyn: a randomized, open-label, crossover study.
The objective of this study was to evaluate parental preference for the treatment of asthmatic children with oral montelukast sodium or inhaled cromolyn sodium. Additionally, we wanted to compare the two drugs in terms of patient preference for treatment, patient and parent satisfaction with treatment, frequency of inhaled albuterol use, adherence to treatment, and safety. This was a 12-week randomized, open-label, crossover study conducted in 42 primary care and asthma/allergy specialty centers in the United States. ⋯ Fewer patients receiving montelukast discontinued because of asthma exacerbation (1.0% vs. 5.0%, respectively), and fewer patients reported worsening asthma while receiving montelukast (3.5% vs. 7.5%, p = 0.036). Parents' and patients' preference, parents' and patients' satisfaction, and patients' adherence to therapy were all significantly better with oral montelukast compared with inhaled cromolyn. Beta-agonist use was decreased when taking montelukast, which was safe and well-tolerated.
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Multicenter Study
Elevated asthma and indoor environmental exposures among Puerto Rican children of East Harlem.
East Harlem in New York City, a community with a large Puerto Rican population, has among the highest rates of asthma hospitalizations and mortality in the United States, but it is not known if the high rates are related to the ethnic composition, environmental or community factors, or if the higher rates reflect differentials in access to appropriate asthma care. A survey was conducted to: (a) estimate the prevalence of current asthma by ethnicity among school-age children, (b) assess indoor environmental risk factors for childhood asthma, and (c) assess health care utilization and school absences associated with childhood asthma. ⋯ The prevalence of current asthma was significantly higher among Puerto Ricans, who had higher symptomatic frequency and greater diagnosis rates. Although all children with asthma in the East Harlem study appear to be sensitive to selected indoor environmental risk factors, only Puerto Rican children with asthma appear to be sensitive to the presence of rodents in their buildings. However, their higher school absence rate suggests problems with routine asthma management that could be addressed by improved medical management, programs to help parents manage their children's asthma, or school staff assistance with medications.