Additional Asthma Medication Research Articles

Budesonide Inhalation Suspension Versus Montelukast in Children Aged 2 to 4 Years with Mild Persistent Asthma

Budesonide inhalation suspension (BIS) and montelukast provide acceptable asthma control, whereas overall measures favored BIS in children aged 2 to 8 years with mild persistent asthma. We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with asthma. Data were derived from a 52-week, open-label, randomized, active-controlled, multicenter study (NCT00641472). Children with mild asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily. Patients were stepped up to twice-daily BIS or oral corticosteroids for mild or severe asthma worsening, respectively. Primary efficacy assessment was time to first additional asthma medication for exacerbation over 52 weeks. Two hundred two patients, age 2 to 4 years, received BIS (n = 105) or montelukast (n = 97). No difference was observed between the BIS and montelukast groups in median time to first additional asthma medication over 52 weeks (183 vs 86 days). Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks (21.9% vs 37.1%; P = .022), the rate (number/patient/year) of additional courses of medication (1.35 vs 2.30; P = .003), the rate of additional oral steroid therapy (0.44 vs 0.88; P = .008), and caregivers' ability to manage the patient's symptoms (P = .026). Both treatments were well tolerated. BIS and montelukast provided acceptable asthma control in children aged 2 to 4 years with mild persistent asthma with no significant difference between treatments in the primary end point; however, several secondary outcomes showed statistically significant differences (and many had numerical differences) in favor of BIS over montelukast.

A retrospective database analysis on persistence with inhaled corticosteroid therapy: comparison of two dry powder inhalers during asthma treatment in Germany

Asthma is one of the most common chronic diseases worldwide. Patient persistence with treatment is essential to achieve sufficient outcomes, in particular to avoid exacerbations. To investigate inhaled corticosteroid (ICS) therapy with two different inhalers (Novolizer® and Turbuhaler®) by comparing persistence, concomitant use of additional asthma medication and occurrence of exacerbations in real life. A retrospective analysis of prescription data from outpatient treatment was performed using the IMS Disease Analyzer. It provides longitudinal anonymized patient data from ~ 3,000 office-based physicians in Germany. Treatment persistence of asthma patients (ICD 10 code: J45) using 200 μg budesonide either via Novopulmon®/Budecort® (Novolizer group = NOV) or Pulmicort® (Turbuhaler group = TUR) was compared. Eligible patients hadthe first prescription of ICS medication (index day) between June 2001 and September 2007 and a data history available for at least twelve months before and after the index day. Analysis of 1,780 NOV and 664 TUR patients revealed that 1 year after index day, 89% NOV patients remained on their ICS compared to 85% TUR patients. NOV patients changed significantly less often and later to another ICS (p = 0.0108; log-rank test). Significantly fewer NOV patients switched temporarily or permanently to another ICS during the observation time (NOV group: 14.7%; TUR group: 20.8%; p = 0.0002, log-rank test). On average, NOV and TUR patients received comparable prescriptions of short acting medication (NOV more SABA, TUR more formoterol). There was a trend towards fewer prescriptions of systemic corticosteroids in NOV patients. Our results suggest better therapy persistence with NOV compared to TUR during asthma treatment in Germany. This can be a marker of better compliance and may contribute to prevent exacerbations. However, the number of exacerbations per patient year in the NOV group (0.12) compared to the TUR group (0.18) was not statically significantly lower (p = 0.4096).

Stress-related asthma and family therapy: Case study

This paper applies the Biobehavioral Family Model (BBFM) of stress- related illness to the study and treatment of an adolescent with intractable asthma. The model is described, along with supportive research findings. Then a case study is presented, demonstrating how the model is clinically applied. We tell the story of an asthmatic adolescent presenting for therapy due to her intense asthmatic crises, and the case is presented to exemplify how the BBFM can help understand the family-psychobiological contribution to exacerbation of disease activity, and therefore guide treatment towards the amelioration of severe physical symptoms. Facets of the patient’s intra-familial interactions are consistent with the BBFM, which support clinical validation of the model. In the case described, it is likely that additional asthma medications would not have had the desired ameliorative effect, because they did not target the family relational processes contributing to the symptoms. The recognition of the influences of family relational processes on the disease was crucial for effective intervention. The therapy incorporates and weaves together BBFM understanding of family patterns of interaction and physiological/medical concerns integrated with Bowenian intervention strategies. This case study validates the importance and usefulness of BBFM for intervention with stress-sensitive illnesses such as asthma.

Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience

BackgroundOmalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists. ObjectivesMedical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational “real-life” study. MethodsSixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids). ResultsOutcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p < 0.0001 at 4 years after treatment]. Similarly, FVC increased statistically significant versus baseline [ΔFVC (% pred.) = +20 p = 0.002 at 4 months, ΔFVC (% pred.) = +22.6 p = 0.0002 at 4 years]. The level of asthma control as evaluated by ACT was significantly improved after treatment (+12% p = 0.001 at 4 months, +24% p < 0.0001 at 4 years). Omalizumab treatment reduced significantly asthma exacerbations rate (−65% p = 0.0002 at 1 year, and −70% p < 0.0001 at 4 years). The use of inhaled steroids decreased statistically significant after 4 months (p = 0.017), 1 year (p = 0.029) and 4 years (p = 0.014) of omalizumab treatment. ConclusionsThis long-term “real-life” study demonstrated significant improvement in lung function and other clinical outcomes after omalizumab treatment, evident at 4 months, and sustained after 1 and 4 years suggesting its efficacy in severe allergic asthma, in the “real-life” practice.

Clinical Benefits of 7 Years of Treatment with Omalizumab in Severe Uncontrolled Asthmatics

Rationale. Severe asthma is characterized by inadequate symptom control and by high rate of inflammation despite high doses of steroids. Omalizumab, a recombinant humanized monoclonal anti-IgE, provides a new therapeutic strategy in severe allergic asthma. Aims. This study was aimed to assess whether long-term treatment with omalizumab improved clinical control in severe asthmatics. Methods. We investigated omalizumab effects on asthma outcomes evaluating seven severe allergic asthmatic patients who were treated for 7 years with add-on omalizumab. Number of exacerbations, use of antibiotics, additional asthma medications (systemic steroids, nebulized steroids and bronchodilators), and spirometry were analyzed before and after omalizumab treatment. Results. Omalizumab was well tolerated by all the studied patients. It improved FEV1 and FEV1/FVC ratio and reduced symptom score, asthma exacerbations, use of antibiotics, and use of nebulized steroids, bronchodilators, and oral corticosteroids. These effects were evident after 4 years of treatment and more pronounced after 7 years of treatment. Conclusions. This study underlines the utility of a long-term treatment with omalizumab to improve asthma clinical outcomes in severe asthmatics.

Comparative Study of Budesonide Inhalation Suspension and Montelukast in Young Children With Mild Persistent Asthma

Szefler SJ, Baker JW, Uryniak T, Goldman M, Silkoff PE. J Allergy Clin Immunol. 2007;120(5):1043–1050 PURPOSE OF THE STUDY. To evaluate the efficacy of budesonide inhalation suspension (Pulmicort respules) compared with montelukast (Singulair) for controlling asthma symptoms in young children with mild persistent asthma. STUDY POPULATION. This was a prospective study of 395 children, aged 2 to 8 years, diagnosed with mild persistent asthma recruited from 55 US centers. Approximately 12% of the subjects had previous histories of inhaled corticosteroid (ICS) use. METHODS. Subjects were randomly assigned to receive either budesonide 0.5 mg or montelukast 4 to 5 mg daily and were followed for 52 weeks. Compliance was assessed by daily electronic diary review. For mild asthma exacerbations, step-up therapy consisted of the addition of a morning dose of budesonide 0.5 mg in both arms. For severe asthma exacerbations, subjects received a 3- to 10-day standardized course of oral steroids. The primary end point was evaluated by using the intention-to-treat population and was defined as time to first additional medication for asthma worsening at 52 weeks. Secondary end points included the time to additional asthma medication and rates of occurrence of mild and severe asthma exacerbations. Changes in symptom scores, peak flows, rescue-medication use, and pulmonary-function test results were also evaluated. RESULTS. Kaplan-Meier probability curves showed that the primary outcome measurement, time to the first additional asthma medication, was not significantly different between the 2 groups at 52 weeks (P = .3). There was a significant increase in the time to first additional asthma medication in the budesonide group compared with the montelukast group at 12 weeks (P = .05). The percentage of subjects requiring step-up therapy in the budesonide group versus the montelukast group at 12 weeks was 29.1% versus 38.6% (not significant [NS]), at 26 weeks was 41.3% versus 48.2% (NS), and at 52 weeks was 52% versus 56.9% (NS), respectively. The budesonide group achieved significantly improved morning and evening peak flow values compared with the montelukast group at 12 weeks (P = .005–.007). The rate of mild and severe asthma exacerbations per subject per year in the budesonide and montelukast groups was 1.23 and 1.63, respectively (P = .034). There was no significant difference in the number of severe asthma exacerbations between the 2 groups. Both treatment groups showed nonsignificant improvements in changes from baseline asthma scores, 24-hour rescue-medication use, and medication- and asthma-free days. CONCLUSIONS. Both budesonide and montelukast are effective and well-tolerated as controller medications in children aged 2 to 8 years with mild persistent asthma. Results favored budesonide for several secondary outcome measures. REVIEWER COMMENTS. Previous studies have shown that ICSs are more effective asthma-controller medications compared with montelukast in children older than 6 years. Although this study failed to show statistical significance in the primary outcome, it provides data supporting certain treatment benefits of ICSs in children younger than 6 years (257 of 395 children were &amp;lt;5 years old). Compared with previous studies, these children had milder asthma, with only 12% having taken ICSs before enrollment.

The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: Effectiveness of early intervention with budesonide in mild persistent asthma

The Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study enrolled 7241 patients aged 5 to 66 years with recent-onset, mild persistent asthma to assess early intervention with the inhaled corticosteroid budesonide on long-term asthma control. The open-label phase of the START study was included to determine the effect on lung function and asthma control of adding budesonide to the reference group patients who had not initially received inhaled corticosteroids. Patients were randomized to double-blind treatment with budesonide, 200 mug (those aged < 11 years) or 400 mug once daily, or placebo plus the usual asthma therapy for 3 years, after which all patients received 2 years of open-label treatment with budesonide once daily. During the full 5-year study period, postbronchodilator FEV(1) percent predicted decreased, irrespective of randomized treatment during the double-blind phase, by an average of 2.22% (SE, 0.15%). However, patients with inhaled budesonide in the double-blind phase had a significantly lower risk (odds ratio, 0.61; P < .001) of a severe asthma-related event during the full 5-year study period than those in the reference group. Moreover, patients in the reference group used more additional asthma medications during both the open-label and double-blind phases. In mild persistent asthma early intervention with inhaled budesonide was associated with improved asthma control and less additional asthma medication use.

Comparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma

Budesonide inhalation suspension and the leukotriene receptor antagonist montelukast have demonstrated efficacy in children with mild persistent asthma, but comparative long-term studies in young children are needed. To compare the long-term efficacy and safety of budesonide inhalation suspension and montelukast. After a run-in period, children 2 to 8 years old with mild asthma or recurrent wheezing were randomized to once-daily budesonide inhalation suspension 0.5 mg or once-daily oral montelukast 4 or 5 mg for 52 weeks. Subjects were stepped up to twice-daily budesonide inhalation suspension or oral corticosteroids for mild or severe asthma worsening, respectively. The primary outcome was time to first additional medication for asthma worsening at 52 weeks. Secondary variables included times to the first additional asthma medication measured at 12 and 26 weeks; times to the first asthma exacerbation (mild and severe) measured at 12, 26, and 52 weeks; exacerbation rates (mild and severe) over a period of 52 weeks; diary variables (eg, peak expiratory flow [PEF]); patient-reported outcomes; and Global Physician and Caregiver Assessments. No significant between-group differences were observed for time to first additional asthma medication at 52 weeks; however, time to first additional asthma medication was longer (unadjusted P = .050) at 12 weeks and exacerbation rates were lower over a period of 52 weeks (unadjusted P = .034) for budesonide versus montelukast. Time to first severe exacerbation (requiring oral corticosteroids) was similar in both groups, but the percentage of subjects requiring oral corticosteroids over a period of 52 weeks was lower with budesonide (25.5% vs 32.0%). Peak flow and Caregiver and Physician Global Assessments favored budesonide. Both treatments provided acceptable asthma control; however, overall measures favored budesonide inhalation suspension over montelukast. These findings are consistent with studies in older children demonstrating better outcomes with inhaled corticosteroids versus montelukast.

Effectiveness of early budesonide intervention in Caucasian versus Asian patients with asthma: 3‐year results of the START study

Few studies have assessed the effectiveness of inhaled corticosteroid therapy exclusively in Asian patients with asthma. The present analysis compared the efficacy of early intervention with inhaled budesonide in Caucasian and Asian patients over the first 3 years of the inhaled Steroid Treatment As Regular Therapy in early asthma study. Patients aged 5-66 years with mild persistent asthma of <or=2 years' duration were randomized to 3 years of double-blind treatment with once-daily budesonide 200 microg (for patients aged<11 years) or 400 microg administered via Turbuhaler or placebo, plus usual asthma therapy. Budesonide significantly improved asthma outcomes in both Caucasian (n=4661) and Asian (n=1995) patients compared with reference therapy (placebo plus usual asthma therapy). Budesonide reduced the risk of a first severe asthma-related event by 42% and 49% in Caucasian and Asian patients, respectively, over the 3-year treatment period (P<0.001 for both). Moreover, budesonide significantly increased symptom-free days, decreased nights with sleeping problems, improved pre- and postbronchodilator FEV1 and reduced the need for additional asthma medications of particular drug classes compared with reference therapy. Except for differences in the patterns of use of additional asthma medications, outcomes with budesonide and overall adverse events were similar in the Caucasian and Asian patient populations. Inhaled budesonide administered once daily in Asian patients with recent-onset, mild persistent asthma significantly improved asthma control and pulmonary function compared with reference therapy. Moreover, this effectiveness paralleled that observed in Caucasian patients.

Montelukast, Compared With Fluticasone, for Control of Asthma Among 6- to 14-Year-Old Patients With Mild Asthma: The Mosaic Study

Purpose of the Study. Per current asthma guidelines, montelukast is considered a suitable alternative to inhaled corticosteroids (ICSs) for the treatment of mild persistent asthma, and this study was conducted to evaluate the use of oral montelukast compared with inhaled fluticasone in children with mild asthma. Study Population. Children (aged 6–14 years) with mild persistent asthma participating in the Montelukast Study of Asthma in Children (MOSAIC) study. Methods. In this 12-month, multicenter, randomized, double-blind, noninferiority comparison study, patients were randomly assigned to receive oral montelukast 5 mg once a day (n = 495) or inhaled fluticasone 100 μg twice a day (n = 499) after an appropriate run-in period. After baseline evaluations, patients were evaluated at 4-month intervals with spirometry and review of an asthma diary card. The primary end point, the percentage of asthma rescue-free days (RFDs), included days with no rescue-medication use and no asthma-related primary care or urgent care visits or hospitalizations. Secondary end points included forced expiratory volume in 1 second (FEV1), use of additional asthma medications, asthma attacks, β-agonist use, and peripheral blood eosinophil levels. Results. The mean percentage of RFDs was 84% in the montelukast group compared with 86.7% in the fluticasone group. The least-squares means difference was −2.8% (95% confidence interval: −4.7% to −0.9%), which represents a difference of &amp;lt;1 day/month. Both montelukast and fluticasone were associated with improvement in FEV1 (percent predicted) from baseline as well as reduction in the percentage of days with β-agonist use, reduction in blood eosinophils, and improvement in patient-perceived asthma control and asthma quality-of-life scores; however, fluticasone was significantly favored in terms of FEV1, β-agonist use, asthma control, and quality of life. Montelukast was associated with the increased use of systemic corticosteroids (17.8% vs 10.5%; P ≤ .001) and a higher percentage of patients with an asthma attack (32.2% vs 25.6%) compared with fluticasone. Conclusions. Montelukast was not inferior to fluticasone in terms of asthma RFDs; however, the use of montelukast was associated with more asthma attacks and more systemic steroid use. FEV1, β-agonist use, and quality of life improved significantly better for those in the fluticasone group. Reviewer Comments. This study represents the first direct comparison between montelukast and an ICS measuring differences in multiple parameters of asthma control in children with mild persistent asthma. This study establishes the noninferiority of montelukast compared with fluticasone in terms of RFDs; however, in terms of FEV1, systemic corticosteroid use, number of asthma attacks and β-agonist use, fluticasone was significantly superior to montelukast. This study underscores the fact that asthma control cannot be determined with just one measure and confirms the role of montelukast as an alternative to ICSs as suggested by the current guidelines. The role of montelukast in future asthma guidelines is currently under investigation. Future studies are needed for evidence-based clinical application.

Efficacy and safety of montelukast in adults with asthma and allergic rhinitis

Several clinical studies have confirmed the effectiveness of montelukast 10mg orally in adults with both asthma and allergic rhinitis. The objective of this phase IV study was to investigate the efficacy and safety of montelukast 10mg in adults with both asthma and allergic rhinitis in a real-life setting. Data from 5855 patients (mean age: 42.8+/-15.4 years) were collected and analyzed following treatment for 4-6 weeks. Efficacy was analyzed by comparing baseline values of: general, day- and night-time improvement in asthma symptoms, need for rescue medication or inhaled corticosteroids (ICSs), general and specific improvement in allergic rhinitis symptoms, reduction in rhinitis medication use, and general and specific quality of life (QoL) improvement with values collected at the end of the observation period of 4-6 weeks. Following treatment with 10mg montelukast 86.5% (n=4547) of patients reported a strong or marked improvement in day-time asthma symptoms and 88.5% (n=4367) reported improvement in night-time symptoms. A similarly high proportion of patients had a strong or marked improvement in all symptoms of allergic rhinitis (i.e. sneezing/itching (84%), rhinorrhea (81.7%), nasal congestion (79.3%), watery eyes (78.4%) and red or burning eyes (77.7%). The use of asthma and rhinitis medication was also reduced. 92.3% (n=5685) of all patients intended to continue montelukast therapy. Overall QoL was "very good" or "good" in 85.2% of patients (n=4991) and a "strong" or "marked" improvement in each of the four domains of sleep, work, everyday life and physical activity. Montelukast was well tolerated. Adverse drug reactions occurred in 14 out of 6158 patients. None of the adverse events was serious. Accordingly, montelukast 10mg is a safe and effective treatment for patients with both asthma and allergic rhinitis.

Is a two‐week trial of oral prednisolone predictive of target lung function in pediatric asthma?

We used a 2-week trial of prednisolone to determine "target" lung function for subsequent asthma therapy. The aim of this study was to evaluate whether some children exceed their "target" forced expired volume in 1 sec (FEV1) on subsequent visits in the following year, and whether this is associated with particular clinical or pathological features. Children (aged 6-16 years) with difficult asthma underwent spirometry and exhaled nitric oxide (FE(NO)) measurements before and after 2 weeks of prednisolone 40 mg/day. At the end of the course, subepithelial eosinophils and reticular basement membrane thickness were assessed. The highest FEV1 obtained in a 1-year follow-up was compared with the poststeroid postbronchodilator ("target") FEV1. Four of 22 children (18%) demonstrated an increase of > 9% above their "target" FEV1 during follow-up. None of these children had been prescribed additional asthma medications. Three of 7 children with persistent airflow limitation (PAL; poststeroid postbronchodilator FEV1 < 80% predicted) recorded an FEV1 > 80% predicted during follow-up. The median (interquartile range) number of subepithelial eosinophils was significantly higher in children who exceeded their target FEV1 than in children who did not (12.4 (8.5-39.9) vs. 1.4 (0.0-4.8) cells/mm2, P = 0.018). In conclusion, a 2-week course of prednisolone is not necessarily predictive of "target" lung function. Definitions such as PAL should be regularly reviewed on individual basis.

Steroids and the Acute Management of Viral-Induced Wheezing

Emergency Medicine| March 01 2004 Steroids and the Acute Management of Viral-Induced Wheezing AAP Grand Rounds (2004) 11 (3): 31–32. https://doi.org/10.1542/gr.11-3-31 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Twitter LinkedIn Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Steroids and the Acute Management of Viral-Induced Wheezing. AAP Grand Rounds March 2004; 11 (3): 31–32. https://doi.org/10.1542/gr.11-3-31 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search toolbar search search input Search input auto suggest filter your search All PublicationsAll JournalsAAP Grand RoundsPediatricsHospital PediatricsPediatrics In ReviewNeoReviewsAAP NewsAll AAP Sites Search Advanced Search Topics: steroids, wheezing, prednisolone Source: Csonka P, Kaila M, Laippala P, et al. Oral prednisolone in the acute management of children age 6 to 35 months with viral respiratory infection-induced lower airway disease: a randomized placebo-controlled trial. J Pediatr. 2003:143:725–730. Although bronchiolitis is a self-limiting disease for most patients, some have prolonged symptoms and require hospitalization. The use of steroids in the acute management of bronchiolitis in infants and young children remains controversial. Therefore, investigators at the Pediatric Research Center, Tampere University Hospital in Tampere, Finland completed a randomized, double-blind, placebo-controlled study on 230 children, age 6 to 35 months, who were seen in the emergency department (ED) with acute wheezing, tachypnea, or use of accessory respiratory muscles in the presence of an apparent viral respiratory infection (rhinorrhea or temperature >37.5°C). Patients with asthma were excluded. Eligible patients were randomized to receive either 2 mg/kg of oral prednisolone in the ED and 1 mg/kg twice daily for 3 more days, or an equivalent amount of placebo. Hospitalization and the use of other bronchodilator medications were at the discretion of the attending physicians. The primary outcome measured was development of severe respiratory symptoms that required additional asthma medications. Secondary outcomes included hospitalization rate from the ED, hospital length of stay, long hospitalizations (≥3 days), and duration of symptoms. There was no difference in hospitalization rate between the 2 groups, with 53% of placebo patients and 54% of prednisolone patients requiring admission. Of the hospitalized patients, a larger number who received placebo needed additional asthma medications (39%) than those that received prednisolone (19%, P=.018). Median length of stay in the hospital was shorter in the prednisolone group (2.0 versus 3.0 days, P=.06), and fewer prednisolone patients required prolonged hospitalizations (47.5% versus 67.7%, P=.023). Median duration of symptoms was also less in the prednisolone group (1.0 versus 2.0, P<.001). Several studies have been published on the effectiveness of steroids in bronchiolitis, and they have led to varying conclusions.1–,5 A recent study of ED patients who received 1 mg/kg of dexamethasone or placebo showed a lower hospitalization rate in the steroid group (19% versus 44%).1 Other studies including a meta-analysis have shown significant improvement in symptoms and length of hospitalization when steroids are provided to patients with bronchiolitis.2,3 However, there are other published trials of steroid use in bronchiolitis that showed no efficacy.4,5 The current study adds further evidence that steroids provide a significant benefit to patients with bronchiolitis. However, there are some methodologic features of the present study that require careful consideration. Despite the authors’ attempts to concentrate on "a relatively homogenous group of children," the lack of viral testing most likely resulted in the inclusion of a heterogenous group of study subjects. Enrollment included patients up to age 35 months, with a mean age of over 16 months in both randomized groups. This represents an older study population than most other studies. This study also included patients that... You do not currently have access to this content.

Asthma control and steroid doses 5 years after early or delayed introduction of inhaled corticosteroids in asthma: a real-life study

We evaluated asthma control and medication use 5 years after introduction of an inhaled corticosteroid (budesonide via Turbuhaler ®) in 462 patients with persistent asthma and symptoms of different duration. An early treatment group with symptoms for <2 years (group A) was compared with a delayed treatment group (group B) (median duration 5 years and 3 months). Most patients received budesonide 400 μg twice daily as initial dose. We report 5-year follow-up data on 404 patients (group A n=253; group B n=151) and on a few more patients after treatment for 6 months, 1 year and 3 years. At 5 years the mean maintenance doses of budesonide were 412 μg (A) and 825 μg (B), respectively ( P<0.001). Nevertheless, treatment goals (normal lung function, normal exercise tolerance, minimal use of reliever medication, no asthma exacerbations) were all statistically significantly more frequently achieved in group A. At 5 years group B patients also used significantly more additional asthma medications, e.g. inhaled long-acting β 2-agonists by 64% compared with 6% in group A. In group A 43 patients (17%) had been able to stop budesonide treatment compared to five patients (3%) in group B. A subgroup of group B patients with higher mean baseline FEV 1 values than group A showed nevertheless significantly poorer response. No treatment-related serious adverse events were reported. Budesonide was well tolerated in both groups. Conclusion: Duration of asthma symptoms when starting treatment with an inhaled corticosteroid is an important determinant for the response. Early treatment gives significantly better airway function and asthma control than delayed treatment and at lower maintenance doses.

Oral prednisolone in the acute management of children age 6 to 35 months with viral respiratory infection-induced lower airway disease: a randomized, placebo-controlled trial

Objective To investigate the efficacy of oral prednisolone in virally induced respiratory distress. Study design Randomized, double-blind, placebo-controlled trial involving 230 children age 6 to 35 months in the emergency department. Each patient received either oral prednisolone (2 mg/kg/d) or placebo for 3 days. Results The hospitalization rates were similar between the two groups. For admitted children (n = 123), the median length of stay was 1 day shorter in the prednisolone group (2 vs 3 days, P = .060). The proportion of children requiring ≥3 days of hospitalization was 47.5% in the prednisolone group and 67.7% in the placebo group ( P = .023). There was less need for additional asthma medication (18.0% vs 37.1%, P = .018) in the prednisolone group. The median duration of symptoms of respiratory distress was 1 day in the prednisolone group versus 2 days in the placebo group both among the hospitalized ( P<.001) and nonhospitalized children ( P = .006). Conclusion A 3-day course of oral prednisolone effectively reduced disease severity, length of hospital stay, and the duration of symptoms among children 6 to 35 months old with virally induced respiratory distress.

Asthma outcome measures

Asthma outcome measures

Pediatric asthma assessment: Validation of 2 symptom diaries

Accurate assessment of the value of asthma interventions in pediatric clinical trials is an essential step toward the improvement of the treatment of this disorder in children. Conventional pulmonary function measures can be infeasible and unreliable in younger children, particularly for use in multisite studies. As an alternative or supplemental approach, diary questionnaires completed by the patients or their caregivers may provide valuable data regarding the efficacy of asthma interventions in pediatric clinical trials. These questionnaires, however, have routinely not been validated for use in pediatric populations. Two pediatric diary questionnaires (the child-completed Pediatric Asthma Diary [PAD] and the parent/caregiver-completed Pediatric Asthma Caregiver Diary [PACD]) were designed to evaluate asthma symptoms in children aged 6 to 14 years and 2 to 5 years, respectively. The validity of these diary questionnaires was evaluated in 2 separate prospective studies that included children who were divided into 2 asthma groups: stable (requiring no additional asthma medication) and unstable (requiring either an increase in or the addition of asthma medication). Both scales displayed significant discriminant validity, construct validity, and responsiveness to change in asthma therapy. Only the PACD detected differences between groups in nighttime symptoms, such as awakenings caused by asthma. These validity studies suggest that diary questionnaires such as the PAD and PACD can be valuable as an alternative for the evaluation of interventions in pediatric asthma when pulmonary function testing is inappropriate or as an adjunct to such objective measures. (J Allergy Clin Immunol 2001;107:S465-72.)