Changes in Bronchial Reactivity in Asthmatic Children After Treatment with Beclomethasone Alone or in Association with Salbutamol

Bennati, D; Piacentini, Giorgio; Peroni, Diego; Sette, L.; Testi, Rossana; Boner, Attilio

doi:10.3109/02770908909073279

Cited by 35 publications

(7 citation statements)

References 10 publications

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“…However, the subjects used frequent inhalations of rescue β 2 agonist throughout the study making the results difficult to interpret in terms of a possible drug interaction. A small study of salbutamol and beclomethasone in asthmatic children found no significant difference between the effects of combined treatment and beclomethasone alone on methacholine responsiveness although, as in the present study, there was a trend to greater benefit from the combination 18. In contrast, two earlier studies of regular β agonist treatment do not suggest a positive interaction with inhaled corticosteroids.…”

Section: Discussioncontrasting

confidence: 79%

Randomised trial of an inhaled beta 2 agonist, inhaled corticosteroid and their combination in the treatment of asthma

Hancox

Cowan

Flannery

et al. 1999

Thorax

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Background-Although many asthmatic patients are treated with a combination of 2 agonist and corticosteroid inhalers, the clinical eVects of combining the drugs are unknown. Studies on the early asthmatic response to allergen suggest that 2 agonists may reduce the benefit of inhaled corticosteroids. A study of the eVects of combining the drugs on asthma control was undertaken. Methods-Sixty one subjects with mild to moderate asthma were randomised to a double blind crossover comparison of inhaled budesonide (200-400 µg twice daily), terbutaline (500-1000 µg four times daily), combined treatment, and placebo. Each treatment was given for six weeks following a four week washout period. Ipratropium was used for symptom relief. Treatments were ranked from worst (1) to best (4) based on need for oral steroid, mean morning peak flow, nocturnal awakening, ipratropium use, and asthma symptoms. Lung function and bronchial hyperresponsiveness were measured before and after each treatment. Results-Evaluable data for all four treatments were obtained from 47 subjects. The mean rank of each treatment was: placebo = 2.05; terbutaline = 2.13; budesonide = 2.48; combined treatment = 3.34. Combined treatment was ranked significantly better than any other treatment (p<0.01). Mean (95% CI) morning and evening peak flows were 14 (5 to 23) and 24 (15 to 34) l/min higher, respectively, during combined treatment than during budesonide, and 27 (17 to 37) and 15 (7 to 23) l/min higher than during terbutaline. Asthma symptoms tended to be least frequent during combined treatment but were not significantly diVerent from budesonide alone. There was no significant diVerence between combined treatment and budesonide alone for lung function and bronchial hyperresponsiveness. Conclusions-In this group of mild to moderate asthmatic subjects the combination of 2 agonist and corticosteroid gave better asthma control than either treatment alone. There was no evidence that regular 2 agonist treatment impaired the beneficial eVect of inhaled corticosteroid.

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Section: Discussioncontrasting

confidence: 79%

Randomised trial of an inhaled beta 2 agonist, inhaled corticosteroid and their combination in the treatment of asthma

Hancox

Cowan

Flannery

et al. 1999

Thorax

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“…Reference tracking of the GINA guideline, systematic reviews and included references did not yield additional references. Twenty-three trials, conducted between 1984 and 2010, met the inclusion criteria and were included [6-10,19-36]. Additional file 4 shows the study characteristics of the 23 trials with 4,129 patients ranging in age from 4 to 18 years; we included 6 trials with a lower age range of 4 years, but with a mean or median between 5 and 18 years [6,9,29,31,32,36].…”

Section: Resultsmentioning

confidence: 99%

A systematic review with attempted network meta-analysis of asthma therapy recommended for five to eighteen year olds in GINA steps three and four

et al. 2012

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BackgroundThe recommendations for the treatment of moderate persistent asthma in the Global Initiative for Asthma (GINA) guidelines for paediatric asthma are mainly based on scientific evidence extrapolated from studies in adults or on consensus. Furthermore, clinical decision-making would benefit from formal ranking of treatments in terms of effectiveness.Our objective is to assess all randomized trial-based evidence specifically pertaining to 5-18 year olds with moderate persistent asthma. Rank the different drug treatments of GINA guideline steps 3&4 in terms of effectiveness.MethodsSystematic review with network meta-analysis. After a comprehensive search in Central, Medline, Embase, CINAHL and the WHO search portal two reviewers selected RCTs performed in 4,129 children from 5-18 year old, with moderate persistent asthma comparing any GINA step 3&4 medication options. Further quality was assessed according the Cochrane Collaboration’s tool and data-extracted included papers and built a network of the trials. Attempt at ranking treatments with formal statistical methods employing direct and indirect (e.g. through placebo) connections between all treatments.Results8,175 references were screened; 23 randomized trials (RCT), comparing head-to-head (n=17) or against placebo (n=10), met the inclusion criteria. Except for theophylline as add-on therapy in step 4, a closed network allowed all comparisons to be made, either directly or indirectly. Huge variation in, and incomplete reporting of, outcome measurements across RCTs precluded assessment of relative efficacies.ConclusionEvidence-based ranking of effectiveness of drug treatments in GINA steps 3&4 is not possible yet. Existing initiatives for harmonization of outcome measurements in asthma trials need urgent implementation.

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“…The difference the change in PC20 between the BDP and the placebo group was used for calculation of sample size [7]. Using the methacholine PD20 as end point, Kerrebijn et al [8] compared the effects of terbutaline (2000 gg daily) and budesonide (400 gg daily).…”

Section: Resultsmentioning

confidence: 99%

Sample sizes for comparative inhaled corticosteroid trials with emphasis on showing therapeutic equivalence

Zanen¹,

Lammers²

1995

Eur J Clin Pharmacol

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In the near future it is to be expected that many new inhaled corticosteroids or formulations of these drugs will be compared with older ones, to discover whether they are therapeutically equivalent or not. The statistical evaluation of these trials differs from the classic methods. When two averages are similar or differ only slightly, power is very low. The regulatory bodies demand a power of at least 80%. This problem was initially solved by using the so-called power approach. Researchers included enough volunteers to enable them to detect a predefined difference, considered to be without any clinical significance, with a power of 80%. This approach, however, has been shown to be incorrect and has been replaced by the two one-sided tests procedure, where a new sample size equation is derived. Important elements of this new equation are the coefficient of variation of the parameter measured, the difference between the averages of the two groups and the equivalence limit (the difference between the means still tolerable). This equation was used in the present study to estimate the number of volunteers needed in a parallel inhaled corticosteroids equivalence trial. The end points chosen were the changes in FEV1 and PC20 due to the corticosteroid effect. Calculations were performed by extracting data from published placebo-controlled trials, and defining a range of equivalence limits and differences between the group averages. It was shown that a huge number of volunteers (500-1000) will be needed, as a result of the small corticosteroid effect and the high variance.(ABSTRACT TRUNCATED AT 250 WORDS)

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Changes in Bronchial Reactivity in Asthmatic Children After Treatment with Beclomethasone Alone or in Association with Salbutamol

Cited by 35 publications

References 10 publications

Randomised trial of an inhaled beta 2 agonist, inhaled corticosteroid and their combination in the treatment of asthma

Randomised trial of an inhaled beta 2 agonist, inhaled corticosteroid and their combination in the treatment of asthma

A systematic review with attempted network meta-analysis of asthma therapy recommended for five to eighteen year olds in GINA steps three and four

Sample sizes for comparative inhaled corticosteroid trials with emphasis on showing therapeutic equivalence

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