Archive for the ‘Asthma’ Category

Acute Relief of Exercise-Induced Bronchoconstriction by Inhaled Formoterol in Children With Persistent Asthma: ConclusionThe primary outcome parameter, FEV1 at 5 min, showed no difference between formoterol and terbutaline. At 5 min after dosing, the mean increase from each predrug baseline was 62% of the maximum increase for each drug. The median recovery times for for-moterol, terbutaline, and placebo were 5.0 min, 7.4 min, and 44 min, respectively. Similar numbers of standard dose inhalations of formoterol (4.5 ^g) and terbutaline (0.5 mg) gave less systemic activity from formoterol.
EIB is a cardinal symptom in pediatric asthma affecting social and physical development and quality of life more so than in adults. Asthma management strategies today generally recommend the use of SABAs 15 min before exercise. This may be well suited for the scheduled activities of adult life, but it is insufficient for most children. Typically, children exercise spontaneously multiple times during a day, and such repeated pretreatment is a challenge to compliance. Prolonged protection should be preferred to enhance the child’s physical activity.

Read the rest of this entry »

An unexpected result was that the drop in lung function before drug administration on the formot-erol day was statistically significantly smaller than on the placebo day with the drop on the terbutaline day in-between. Baseline antiinflammatory treatment was unchanged, and the analysis revealed no period or carryover effect, so this appears a chance finding and probably reflects the natural variation in severity of bronchial hyperresponsiveness. As a result, the outcome of the analyses of FEV1 and MMEF25-75 depended on the choice of reference point. If using baseline as reference, formoterol would be favored.

Read the rest of this entry »

Acute Relief of Exercise-Induced Bronchoconstriction by Inhaled Formoterol in Children With Persistent Asthma: FEVjFEV1 before (baseline) and 5 min after (predose) exercise are shown in Table 2 together with the percentage drop between these two time points. The drop during the formoterol day (26.4%) most resembled the drop during the screening day (25.5%) but was statistically significantly smaller than during the placebo day (37.3%; p = 0.001). The drop on the terbutaline day (31.6%) was between and not statistically significantly different from either. The order in which treatment days were performed did not influence the drop in FEV1.
The time profile of mean FEV1 is shown in Figure 2. Both formoterol and terbutaline showed statistically significantly larger improvements than placebo at all time points (Table 3). No difference was found between terbutaline and formoterol for the primary outcome parameter (FEV1 at 5 min; p = 0.15), but the difference reached statistical significance in favor of terbutaline at 3 min and 10 min (both p = 0.04), The mean FEV1 at 5 min expressed as percentage of the maximum increase during the 60 min following drug administration were 62% (formoterol), 62% (terbutaline), and 24% (placebo). Source

Read the rest of this entry »

Carryover effects for predose FEV1 were investigated graphically. The baseline value of the study day and the predose value (5 min after exercise) were both used as covariates in the analysis. Time to recovery (time from drug administration until FEV1 had reached within 5% of baseline FEV1) was compared between active treatments using Wilcoxon signed rank-sum test.
The central tendency of time to recovery is presented by median. All tests were two sided at a 5% significance level. The efficacy analysis included all randomized patients with values from at least 2 study days. The number of patients was based on experience from previous studies with exercise tests in children, indicating that 24 patients would give an 80% chance to detect a difference of 8% (corresponding to approximately 0.2 L) between any two treatments. This assumes a two-sided test at a 5% significance level. However, since the actual design had not previously been used, the study could be considered a pilot study.
Read the rest of this entry »

Acute Relief of Exercise-Induced Bronchoconstriction by Inhaled Formoterol in Children With Persistent Asthma: StatisticsSpirometry was performed and results accepted as per American Thoracic Society (ATS) standards (Jaeger MasterScreen; E Jaeger GmbH; Wurzburg, Germany) with the children in a sitting position wearing a nose clip. FEV1 and maximal mid-expiratory flow (MMEF25-75) were recorded before exercise (baseline), after exercise (1 min, 3 min, and 5 min), and after administration of study drug (1 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, and 60 min) [Fig 1]. Baseline spirometry was performed in triplicate. Baseline FEV1 (the highest of three measurements) should be at least 70% of predicted normal value and was not allowed to vary > 15% between study days. Asthma symptoms were not recorded.
Exhaled nitric oxide (FeNO) was measured at baseline (Aero-crine NO System; Aerocrine; Stockholm, Sweden) according to ATS/European Respiratory Journal recommendations, and data on the predictive value of FeNO screening for EIB are reported separately. add comment

Read the rest of this entry »

The study was performed in accordance with the declaration of Helsinki and approved by the local ethics committee (KF 02-082/00) and the Danish Medicines Agency (2612-1507). Before enrollment, informed consent was obtained from both children and parents/legal guardians.
Patients were recruited from two pediatric outpatient clinics in Copenhagen. Children 7 to 15 years old with a diagnosis of persistent asthma and a fall in FEV1 of at least 15% after exercise at enrollment were eligible for participation. Concurrent use of inhaled corticosteroids (ICS) was unchanged during the month prior to enrollment and was kept constant throughout the study. Children who had an asthma exacerbation necessitating a change in dose of ICS or treatment with systemic steroids within 2 months prior to the study were excluded. Before each visit, long-acting p2-agonists (LABAs) were withheld for 24 h, SABAs were withheld for 6 h, and leukotriene receptor antagonists were withheld for 5 days. read more

Read the rest of this entry »

Acute Relief of Exercise-Induced Bronchoconstriction by Inhaled Formoterol in Children With Persistent AsthmaRelief therapy is pivotal to any asthma management plan. The aims of such a therapy are rapid lung function improvement and preferably prolonged action with the option of repeated dosing without risk of side effects. In addition, bronchopro-tection against asthma triggers such as exercise is desired. add comment

Inhaled formoterol is a full (32-agonist. Onset of bronchodilation has been reported to be similar to that of terbutaline and salbutamol in both stable and acute severe asthma and with similar systemic activity. Increasing the dose of formoterol provides an increased therapeutic effect during asthma worsening, as the standard therapeutic dose is at the steep part of its dose-response curve.’ This allows repetitive dosing during days of exacerbations without concerns of safety and potentially increases the effect to the maximal level. In addition, single doses provide a sustained, significant bronchodilation and bronchoprotection over 8 to 12 h in contrast to the 2 to 4 h after short-acting (32-agonist (SABA) as assessed by methacholine challenge, exercise chal-lenge, and cold dry-air hyperventilation.

Read the rest of this entry »

Pages: Prev 1 2 3 4 5 6 7 Next