Dataset Information

Azithromycin or montelukast as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma study.

ABSTRACT:

Background

Clinical trials in children with moderate-to-severe persistent asthma are limited.

Objective

We sought to determine whether azithromycin or montelukast are inhaled corticosteroid sparing.

Methods

The budesonide dose (with salmeterol [50 microg] twice daily) necessary to achieve control was determined in children 6 to 17 years of age with moderate-to-severe persistent asthma. After a budesonide-stable period of 6 weeks, children were randomized in a double-masked, parallel, multicenter study to receive once-nightly azithromycin, montelukast, or matching placebos plus the established controlling dose of budesonide (minimum, 400 microg twice daily) and salmeterol twice daily. Primary outcome was time from randomization to inadequate asthma control after sequential budesonide dose reduction.

Results

Of 292 children screened, only 55 were randomized. Inadequate adherence to study medication (n = 80) and improved asthma control under close medical supervision (n = 49) were the major reasons for randomization failure. A futility analysis was requested by the Data Safety Monitoring Board. In data available for analyses, no differences were noted for either treatment compared with placebo in time to inadequate control status (median: azithromycin, 8.4 weeks [95% confidence limit, 4.3-17.3]; montelukast, 13.9 weeks [95% confidence limit, 4.7-20.6]; placebo, 19.1 weeks [95% confidence limit, 11.7-infinity]), with no difference between the groups (log-rank test, P = .49). The futility analysis indicated that even if the planned sample size was reached, the results of this negative study were unlikely to be different, and the trial was prematurely terminated.

Conclusion

Based on these results, neither azithromycin nor montelukast is likely to be an effective inhaled corticosteroid-sparing alternative in children with moderate-to-severe persistent asthma.

SUBMITTER: Strunk RC

PROVIDER: S-EPMC2737448 | biostudies-literature | 2008 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Azithromycin or montelukast as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma study.

Strunk Robert C RC Bacharier Leonard B LB Phillips Brenda R BR Szefler Stanley J SJ Zeiger Robert S RS Chinchilli Vernon M VM Martinez Fernando D FD Lemanske Robert F RF Taussig Lynn M LM Mauger David T DT Morgan Wayne J WJ Sorkness Christine A CA Paul Ian M IM Guilbert Theresa T Krawiec Marzena M Covar Ronina R Larsen Gary G

The Journal of allergy and clinical immunology 20081025 6

<h4>Background</h4>Clinical trials in children with moderate-to-severe persistent asthma are limited.<h4>Objective</h4>We sought to determine whether azithromycin or montelukast are inhaled corticosteroid sparing.<h4>Methods</h4>The budesonide dose (with salmeterol [50 microg] twice daily) necessary to achieve control was determined in children 6 to 17 years of age with moderate-to-severe persistent asthma. After a budesonide-stable period of 6 weeks, children were randomized in a double-masked, ...[more]

PMID: 18951618

Similar Datasets

Project description:BACKGROUND:Asthma is the most common chronic disease of childhood and a leading cause of childhood morbidity. The aim of the current study was to assess the effectiveness of montelukast administered as monotherapy or in combination with current inhaled corticosteroids (ICS) in pediatric patients with uncontrolled asthma as per the Canadian Asthma Consensus Guidelines. METHODS:Twelve-week, multicentre, open-label, observational study. Primary effectiveness outcome was the proportion of patients achieving asthma control (Asthma Control Questionnaire (ACQ) score ?0.75) at weeks 4 and 12. RESULTS:A total of 328 patients with uncontrolled asthma (ACQ?>?0.75) were enrolled with mean?±?SD age of 6.9?±?3.4 years. Among these, 76 (23.2%) were treated with montelukast monotherapy and 252 (76.8%) with montelukast combined with ICS. By 4 weeks of treatment 61.3% and 52.9% of the patients in the monotherapy and combination group, respectively, achieved asthma control. These proportions increased to 75.0% and 70.9%, respectively, at 12 weeks. Within the monotherapy group, clinically significant improvements in the ACQ score (mean?±?SD of 1.67?±?0.69, 0.71?±?0.70 and 0.50?±?0.52 at baseline, 4 and 12 weeks, respectively; p?<?0.001) and the PACQLQ score (mean?±?SD of 5.34?±?1.14, 6.32?±?0.89 and 6.51?±?0.85 at baseline, 4 and 12 weeks, respectively; p?<?0.001) were observed. In the combination group, the mean?±?SD ACQ score significantly improved from 2.02?±?0.83 at baseline to 0.90?±?0.86 at 4 weeks and 0.64?±?0.86 at 12 weeks (p?<?0.001), while the PACQLQ score improved from 4.42?±?1.35 at baseline to 5.76?±?1.30 at 4 weeks and 6.21?±?1.03 at 12 weeks (p?<?0.001). After a 12-week montelukast add-on therapy, 22.6% of patients reduced their ICS dosage. Similar results were observed among preschool- and school-aged patients. CONCLUSIONS:Montelukast as monotherapy or in combination with ICS represents an effective treatment strategy for achieving asthma control in pediatric patients and improving caregivers' quality of life. TRIAL REGISTRATION:This study is registered at ClinicalTrial.gov: NCT00832455.

Dataset Information

Azithromycin or montelukast as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma study.

Background

Objective

Methods

Results

Conclusion

Publications

Azithromycin or montelukast as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets