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Review
. 2013 Feb 28;2013(2):CD009611.
doi: 10.1002/14651858.CD009611.pub3.

Intermittent versus daily inhaled corticosteroids for persistent asthma in children and adults

Bhupendrasinh F Chauhan  1 , Caroline Chartrand, Francine M Ducharme
Affiliations
Review

Intermittent versus daily inhaled corticosteroids for persistent asthma in children and adults

Bhupendrasinh F Chauhan et al. Cochrane Database Syst Rev. .

Abstract

Background: Daily inhaled corticosteroids (ICS) are the recommended mainstay of treatment in children and adults with persistent asthma. However, often, ICS are used intermittently by patients or recommended by physicians to be used only at the onset of exacerbations.

Objectives: The aim of this review was to compare the efficacy and safety of intermittent versus daily ICS in the management of children and adults with persistent asthma and preschool-aged children suspected of persistent asthma.

Search methods: We searched the Cochrane Airways Group Specialised Register of trials (CAGR) and the ClinicalTrials.gov web site up to October 2012.

Selection criteria: We included randomised controlled trials (RCTs) that compared intermittent ICS versus daily ICS in children and adults with persistent asthma. No co-interventions were permitted other than rescue relievers and oral corticosteroids used during exacerbations.

Data collection and analysis: Two review authors independently assessed trials for inclusion, methodological quality and extracted data. The primary efficacy outcome was the number of patients with one or more exacerbations requiring oral corticosteroids and the primary safety outcome was the number of patients with serious adverse health events. Secondary outcomes included exacerbations, lung function tests, asthma control, adverse effects, withdrawal rates and inflammatory markers. Equivalence was assumed if the risk ratio (RR) estimate and its 95% confidence interval (CI) were between 0.9 and 1.1. Quality of the evidence was assessed using GRADE.

Main results: Six trials (including one trial testing two relevant protocols) met the inclusion criteria for a total of seven group comparisons. The four paediatric trials (two involving preschool children and two school-aged children) and two adult parallel-group trials, lasting 12 to 52 weeks, were of high methodological quality. A total of 1211 patients with confirmed, or suspected, persistent asthma contributed to the meta-analyses. There was no statistically significant group difference in the risk of patients experiencing one or more exacerbations requiring oral corticosteroids (1204 patients; RR 1.07; 95% CI 0.87 to 1.32; the large confidence interval translates into a risk of exacerbations in the intermittent ICS group varying between 17% and 25%, assuming a 19% risk with daily ICS). Age, severity of airway obstruction, step-up protocol used during exacerbations and trial duration did not significantly influence the primary efficacy outcome. No group difference was observed in the risk of patients with serious adverse health events (1055 patients; RR 0.82; 95% CI 0.33 to 2.03). Compared to the daily ICS group, the intermittent ICS group displayed a smaller improvement in change from baseline peak expiratory flow rate (PEFR) by 2.56% (95% CI -4.49% to -0.63%), fewer symptom-free days (standardised mean difference (SMD) -0.15 (95% CI -0.28 to -0.03), fewer asthma control days -9% (95% CI -14% to -4%), more use of rescue β2-agonists by 0.12 puffs/day (95% CI 0 to 0.23) and a greater increase from baseline in exhaled nitric oxide of 16.80 parts per billion (95% CI 11.95 to 21.64). There was no significant group difference in forced expiratory volume in one second (FEV1), quality of life, airway hyper-reactivity, adverse effects, hospitalisations, emergency department visits or withdrawals. In paediatric trials, intermittent ICS (budesonide and beclomethasone) were associated with greater growth by 0.41 cm change from baseline (532 children; 95% CI 0.13 to 0.69) compared to daily treatment.

Authors' conclusions: In children and adults with persistent asthma and in preschool children suspected of persistent asthma, there was low quality evidence that intermittent and daily ICS strategies were similarly effective in the use of rescue oral corticosteroids and the rate of severe adverse health events. The strength of the evidence means that we cannot currently assume equivalence between the two options.. Daily ICS was superior to intermittent ICS in several indicators of lung function, airway inflammation, asthma control and reliever use. Both treatments appeared safe, but a modest growth suppression was associated with daily, compared to intermittent, inhaled budesonide and beclomethasone. Clinicians should carefully weigh the potential benefits and harm of each treatment option, taking into account the unknown long-term (> one year) impact of intermittent therapy on lung growth and lung function decline.

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Conflict of interest statement

Dr. Bhupendrasinh Chauhan holds a postdoctoral scholarship from one of Dr. Ducharme's grants from the Canadian Institute of Health Research and has no conflicts of interest.

Dr. Caroline Chartrand holds no salary support and has no conflicts of interest.

Prof. Francine Ducharme has received travel support, research funds and fees for speaking from GlaxoSmithKline, Novartis, Nycomed and Merck Frosst Inc.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Forest plot of comparison: 1 Intermittent 'as needed' ICS versus daily ICS, outcome: 1.1 Patients with 1 or more exacerbations requiring oral corticosteroids.
4
4
Funnel plot of comparison: 1 Intermittent 'as needed' ICS versus daily ICS, outcome: 1.1 Patients with 1 or more exacerbations requiring oral corticosteroids.
5
5
Forest plot of comparison: 1 Intermittent 'as needed' ICS versus daily ICS, outcome: 1.2 Patients with serious adverse health events.
1.1
1.1. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 1 Patients with 1 or more exacerbations requiring oral corticosteroids.
1.2
1.2. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 2 Exacerbations requiring oral corticosteroids: subgroup analysis for age.
1.3
1.3. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 3 Exacerbations requiring oral corticosteroids: subgroup analysis for duration of treatment.
1.4
1.4. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 4 Exacerbations requiring oral corticosteroids: subgroup analysis for severity of airway obstruction.
1.5
1.5. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 5 Patients with serious adverse health events.
1.6
1.6. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 6 Patients with at least 1 exacerbation requiring emergency department/acute care visit.
1.7
1.7. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 7 Patients with at least 1 exacerbation requiring hospital admission.
1.8
1.8. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 8 Number of exacerbations requiring emergency department visits.
1.9
1.9. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 9 Time to exacerbation requiring oral corticosteroids.
1.10
1.10. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 10 Change from baseline AM PEFR (%).
1.11
1.11. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 11 Change from baseline AM PEFR (L/min).
1.12
1.12. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 12 Change from baseline FEV1 (%).
1.13
1.13. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 13 Change from baseline FEV1 (L).
1.14
1.14. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 14 Change from baseline mean diurnal variation in PEFR.
1.15
1.15. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 15 Change in PC20.
1.16
1.16. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 16 Change from baseline in asthma control days.
1.17
1.17. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 17 Proportion of asthma control days over the period.
1.18
1.18. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 18 Change from baseline mean daily use of β2‐agonists (puffs/day).
1.19
1.19. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 19 Cumulative dose of rescue albuterol (μg) over the period.
1.20
1.20. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 20 Change from baseline in daytime symptom scores.
1.21
1.21. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 21 Change from baseline in asthma symptoms utility index.
1.22
1.22. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 22 Change in proportion of 'symptom‐free days'.
1.23
1.23. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 23 Change from baseline in night‐time awakenings.
1.24
1.24. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 24 Change from baseline in quality of life (QoL).
1.25
1.25. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 25 Days with use of β2‐agonists (%).
1.26
1.26. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 26 Change in exhaled nitric oxide (ppb).
1.27
1.27. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 27 Change in height (cm).
1.28
1.28. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 28 Change in height (Z‐score).
1.29
1.29. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 29 Change in weight (Z‐score).
1.30
1.30. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 30 Change in weight (kg).
1.31
1.31. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 31 Salivary cortisol level.
1.32
1.32. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 32 Overall withdrawals.
1.33
1.33. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 33 Oral candidiasis.
1.34
1.34. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 34 Withdrawal owing to adverse events.
1.35
1.35. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 35 Cumulative dose of ICS over the period (μg beclomethasone equivalent).
1.36
1.36. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 36 Overall adverse effects.
1.37
1.37. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 37 Withdrawal owing to poor asthma control/exacerbations.
1.38
1.38. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 38 Pneumonia.
1.39
1.39. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 39 Nausea.
1.40
1.40. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 40 Headache.
1.41
1.41. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 41 Upper respiratory tract infections.
1.42
1.42. Analysis
Comparison 1 Intermittent 'as needed' ICS versus daily ICS, Outcome 42 Death.
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NCT00163293 {unpublished data only}
    1. Efficacy of ciclesonide inhaled once daily versus other corticosteroids used for treatment of mild asthma in children (4 to 11 y) (BY9010/CA‐101). ClinicalTrials.gov/show/NCT00163293 (accessed 16 October 2012).
NCT00200850 {unpublished data only}
    1. Immunotherapy administered under the tongue to treat dust mite. ClinicalTrials.gov/show/NCT00200850 (accessed 16 October 2012).
NCT00287365 {unpublished data only}
    1. Genetic susceptibility to ozone in mild asthmatic volunteers. ClinicalTrials.gov/show/NCT00287365 (accessed 16 October 2012).
NCT00295737 {unpublished data only}
    1. Effect of an immunotoxin on activated human macrophages in those with allergic rhinitis or mild intermittent asthma. ClinicalTrials.gov/show/NCT00295737 (accessed 16 October 2012).
NCT00337675 {unpublished data only}
    1. Intermittent and daily dosing for episodic (periodic) asthma. ClinicalTrials.gov/show/NCT00337675 (accessed 16 October 2012).
NCT00517816 {unpublished data only}
    1. A single ascending dose study of R1671 in patients with mild intermittent asymptomatic asthma. ClinicalTrials.gov/show/NCT00517816 (accessed 16 October 2012).
NCT00529477 {unpublished data only}
    1. The effects of methacholine challenge administered using three different nebulizers on small airways function. ClinicalTrials.gov/show/NCT00529477 (accessed 16 October 2012).
NCT00565591 {unpublished data only}
    1. Study mild intermittent asthma to assess the topical safety and tolerability of albuterol sulfate Acu‐30™ DPI. ClinicalTrials.gov/show/NCT00565591 (accessed 16 October 2012).
NCT00599027 {unpublished data only}
    1. An exploratory study of nasonex in patients with moderate to severe persistent allergic rhinitis and intermittent asthma. ClinicalTrials.gov/show/NCT00599027 (accessed 16 October 2012).
NCT00805324 {unpublished data only}
    1. Study of the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma (P03472). ClinicalTrials.gov/show/NCT00805324 (accessed 16 October 2012).
NCT00875082 {unpublished data only}
    1. Effect of montelukast on remodelling markers in asthmatic children. ClinicalTrials.gov/show/NCT00875082 (accessed 16 October 2012).
NCT00928668 {unpublished data only}
    1. Efficacy (bronchoprotection) and safety of orally inhaled BI 1744 CL in patients with intermittent asthma. ClinicalTrials.gov/show/NCT00928668 (accessed 16 October 2012).
NCT00989833 {unpublished data only}
    1. Comparing Symbicort as‐needed or Bricanyl as‐needed or Pulmicort once daily + Bricanyl as‐needed in asthma patients. ClinicalTrials.gov/show/NCT00989833 (accessed 16 October 2012).
NCT01002690 {unpublished data only}
    1. COX‐2 inhibition in allergic asthma. ClinicalTrials.gov/show/NCT01002690 (accessed 16 October 2012).
NCT01025648 {unpublished data only}
    1. Randomized, placebo/active controlled crossover, dose‐ranging study for initial evaluation of safety and efficacy in asthma patients. ClinicalTrials.gov/show/NCT01025648 (accessed 16 October 2012).
NCT01095627 {unpublished data only}
    1. Characterization of aerosol generation and transport in the human lung. ClinicalTrials.gov/show/NCT01095627 (accessed 16 October 2012).
NCT01113489 {unpublished data only}
    1. Assessment of oxidative stress markers in the upper and lower airways of atopic children treated with nebulized beclomethasone. ClinicalTrials.gov/show/NCT01113489 (accessed 16 October 2012).
NCT01127035 {unpublished data only}
    1. Sublingual immunotherapy In alternaria‐induced rhinitis. ClinicalTrials.gov/show/NCT01127035 (accessed 16 October 2012).
NCT01137565 {unpublished data only}
    1. Safety, tolerability, and pharcodynamics of AMG 853 in adolescents with asthma. ClinicalTrials.gov/show/NCT01137565 (accessed 16 October 2012).
NCT01144429 {unpublished data only}
    1. Dose finding study for depigoid birch: 4 doses in patients with allergic rhinitis/rhinoconjunctivitis + ‐asthma. ClinicalTrials.gov/show/NCT01144429 (accessed 16 October 2012).
NCT01252758 {unpublished data only}
    1. Dose finding study of albuterol sulfate in patients with intermittent or persistent mild asthma. ClinicalTrials.gov/show/NCT01252758 (accessed 16 October 2012).
NCT01312805 {unpublished data only}
    1. Using computers to assist in the treatment of asthma in a pediatric setting. ClinicalTrials.gov/show/NCT01312805 (accessed 16 October 2012).
NCT01383564 {unpublished data only}
    1. Continuous positive airway pressure use in asthma with moderate to severe obstructive sleep apnea patients. ClinicalTrials.gov/show/NCT01383564 (accessed 16 October 2012).
NCT01395485 {unpublished data only}
    1. Safety, tolerability, and pharmacokinetics of AMG 827 in adolescents with asthma. ClinicalTrials.gov/show/NCT01395485 (accessed 16 October 2012).
NCT01436890 {unpublished data only}
    1. A clinical trial to study the effects of revamilast in patients with chronic persistent asthma. ClinicalTrials.gov/show/NCT01436890 (accessed 16 October 2012).
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