Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children

Bradley S Quon; J. Mark FitzGerald; Catherine Lemière; Neal Shahidi; Francine M Ducharme

doi:10.1002/14651858.CD007524.pub3

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Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 2

Funnel plot of comparison: 1 Maintenance versus increased dose, outcome: 1.1 Need for systemic corticosteroids ‐ parallel‐group studies.

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Analysis 1.1

Comparison 1 Maintenance versus increased dose, Outcome 1 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis).

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Analysis 1.2

Comparison 1 Maintenance versus increased dose, Outcome 2 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by age.

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Analysis 1.3

Comparison 1 Maintenance versus increased dose, Outcome 3 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by smoking status.

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Analysis 1.4

Comparison 1 Maintenance versus increased dose, Outcome 4 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by time elapsed before treatment initiation.

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Analysis 1.5

Comparison 1 Maintenance versus increased dose, Outcome 5 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by maintenance ICS dose.

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Analysis 1.6

Comparison 1 Maintenance versus increased dose, Outcome 6 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by achieved ICS dose.

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Analysis 1.7

Comparison 1 Maintenance versus increased dose, Outcome 7 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by x2 or x4.

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Analysis 1.8

Comparison 1 Maintenance versus increased dose, Outcome 8 Need for systemic corticosteroids ‐ cross‐over studies.

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Analysis 1.9

Comparison 1 Maintenance versus increased dose, Outcome 9 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis).

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Analysis 1.10

Comparison 1 Maintenance versus increased dose, Outcome 10 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by age.

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Analysis 1.11

Comparison 1 Maintenance versus increased dose, Outcome 11 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by smoking status.

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Analysis 1.12

Comparison 1 Maintenance versus increased dose, Outcome 12 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by time elapsed before treatment initiation.

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Analysis 1.13

Comparison 1 Maintenance versus increased dose, Outcome 13 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by maintenance ICS dose.

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Analysis 1.14

Comparison 1 Maintenance versus increased dose, Outcome 14 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by achieved ICS dose.

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Analysis 1.15

Comparison 1 Maintenance versus increased dose, Outcome 15 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by x2 or x4.

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Analysis 1.16

Comparison 1 Maintenance versus increased dose, Outcome 16 Sensitivity analysis ‐ effect of funding on need for systemic corticosteroids ‐ parallel‐group studies.

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Analysis 1.17

Comparison 1 Maintenance versus increased dose, Outcome 17 Unscheduled physician visits ‐ parallel‐group studies.

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Analysis 1.18

Comparison 1 Maintenance versus increased dose, Outcome 18 Unscheduled acute care or emergency department visits or need for hospital admission ‐ parallel‐group studies.

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Analysis 1.19

Comparison 1 Maintenance versus increased dose, Outcome 19 Unscheduled acute care or emergency department visits or need for hospital admission ‐ cross‐over studies.

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Analysis 1.20

Comparison 1 Maintenance versus increased dose, Outcome 20 Duration of exacerbation as defined by time to recovery of lung function.

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Analysis 1.21

Comparison 1 Maintenance versus increased dose, Outcome 21 Duration of exacerbation as defined by time to recovery of symptoms.

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Analysis 1.22

Comparison 1 Maintenance versus increased dose, Outcome 22 Non‐serious adverse events.

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Analysis 1.23

Comparison 1 Maintenance versus increased dose, Outcome 23 Non‐serious adverse event ‐ pharyngitis.

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Analysis 1.24

Comparison 1 Maintenance versus increased dose, Outcome 24 Non‐serious adverse event ‐ glossitis.

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Analysis 1.25

Comparison 1 Maintenance versus increased dose, Outcome 25 Non‐serious adverse event ‐ headaches.

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Analysis 1.26

Comparison 1 Maintenance versus increased dose, Outcome 26 Non‐serious adverse event ‐ psychiatric disturbance (depression, anxiety).

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Analysis 1.28

Comparison 1 Maintenance versus increased dose, Outcome 28 Non‐serious adverse event ‐ GI (nausea, abdominal discomfort).

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Analysis 1.29

Comparison 1 Maintenance versus increased dose, Outcome 29 Non‐serious adverse event ‐ upper respiratory tract infections.

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Summary of findings for the main comparison. Increased compared to stable inhaled steroid dose for exacerbations of chronic asthma in adults and children

Increased compared to stable inhaled steroid dose for exacerbations of chronic asthma in adults and children
Patient or population: patients with exacerbations of chronic asthma (adults and children) Settings: home‐based asthma action plan Intervention: increase inhaled steroid dose Comparison: maintenance inhaled steroid dose
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Maintenance inhaled steroid dose	Increased inhaled steroid dose
Need for rescue oral corticosteroids ‐ parallel‐group studies (ITT analysis)	113 per 1000	98 per 1000 (62 to 154)	OR 0.85 (0.58 to 1.26)	1080 (3 studies)	⊕⊕⊕⊝ moderate¹
Non‐serious adverse events	72 per 1000	143 per 1000 (50 to 343)	OR 2.15 (0.68 to 6.73)	142 (2 studies)	⊕⊕⊕⊝ moderate¹	No serious adverse events were reported.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Few events and wide confidence interval.

Summary of findings for the main comparison. Increased compared to stable inhaled steroid dose for exacerbations of chronic asthma in adults and children

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Comparison 1. Maintenance versus increased dose

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) Show forest plot	3	1080	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.58, 1.26]

2 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by age Show forest plot	2	790	Odds Ratio (M‐H, Fixed, 95% CI)	0.75 [0.49, 1.16]

2.1 Children (< 15 years old)	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Adults (> or = 15 years old)	2	790	Odds Ratio (M‐H, Fixed, 95% CI)	0.75 [0.49, 1.16]
3 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by smoking status Show forest plot	1	290	Odds Ratio (M‐H, Fixed, 95% CI)	1.43 [0.58, 3.50]

3.1 Active smokers	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Ex‐ or never‐smokers	1	290	Odds Ratio (M‐H, Fixed, 95% CI)	1.43 [0.58, 3.50]
4 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by time elapsed before treatment initiation Show forest plot	2	680	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.65, 1.78]

4.1 Time elapsed before initiation (< 48h)	1	390	Odds Ratio (M‐H, Fixed, 95% CI)	0.94 [0.51, 1.74]
4.2 Time elapsed before initiation (> or = 48h)	1	290	Odds Ratio (M‐H, Fixed, 95% CI)	1.43 [0.58, 3.50]
5 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by maintenance ICS dose Show forest plot	3	1080	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.58, 1.26]

5.1 Maintenance ICS dose ‐ Low	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 Maintenance ICS dose ‐ Moderate	3	1080	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.58, 1.26]
5.3 Maintenance ICS dose ‐ High	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by achieved ICS dose Show forest plot	3	1080	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.58, 1.26]

6.1 Achieved ICS dose ‐ Low	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 Achieved ICS dose ‐ Moderate	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 Achieved ICS dose ‐ High	3	1080	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.58, 1.26]
7 Randomised participants who needed systemic corticosteroids ‐ parallel studies (ITT analysis) ‐ subgroup by x2 or x4 Show forest plot	3	1080	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.58, 1.26]

7.1 Double dose	2	680	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.65, 1.78]
7.2 Quadruple dose	1	400	Odds Ratio (M‐H, Fixed, 95% CI)	0.60 [0.32, 1.13]
8 Need for systemic corticosteroids ‐ cross‐over studies Show forest plot	1	36	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.84 [0.47, 130.46]

9 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) Show forest plot	3	399	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.27, 1.74]

10 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by age Show forest plot	2	301	Odds Ratio (M‐H, Random, 95% CI)	0.46 [0.18, 1.18]

10.1 Children (< 15 years old)	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
10.2 Adults (> or = 15 years old)	2	301	Odds Ratio (M‐H, Random, 95% CI)	0.46 [0.18, 1.18]
11 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by smoking status Show forest plot	1	98	Odds Ratio (M‐H, Fixed, 95% CI)	1.69 [0.64, 4.47]

11.1 Active smokers	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11.2 Ex‐ or never‐smokers	1	98	Odds Ratio (M‐H, Fixed, 95% CI)	1.69 [0.64, 4.47]
12 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by time elapsed before treatment initiation Show forest plot	2	305	Odds Ratio (M‐H, Random, 95% CI)	1.02 [0.44, 2.34]

12.1 Time elapsed before initiation (< 48 h)	1	207	Odds Ratio (M‐H, Random, 95% CI)	0.71 [0.36, 1.41]
12.2 Time elapsed before initiation (> or = 48 h)	1	98	Odds Ratio (M‐H, Random, 95% CI)	1.69 [0.64, 4.47]
13 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by maintenance ICS dose Show forest plot	3	399	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.27, 1.74]

13.1 Maintenance ICS dose ‐ Low	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
13.2 Maintenance ICS dose ‐ Moderate	3	399	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.27, 1.74]
13.3 Maintenance ICS dose ‐ High	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
14 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by achieved ICS dose Show forest plot	3	399	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.27, 1.74]

14.1 Achieved ICS dose ‐ Low	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
14.2 Achieved ICS dose ‐ Moderate	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
14.3 Achieved ICS dose ‐ High	3	399	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.27, 1.74]
15 Participants (with at least one use of study inhaler) who needed systemic corticosteroids ‐ parallel‐group studies (modified ITT analysis) ‐ subgroup by x2 or x4 Show forest plot	3	399	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.27, 1.74]

15.1 Double dose	2	305	Odds Ratio (M‐H, Random, 95% CI)	1.02 [0.44, 2.34]
15.2 Quadruple dose	1	94	Odds Ratio (M‐H, Random, 95% CI)	0.27 [0.11, 0.67]
16 Sensitivity analysis ‐ effect of funding on need for systemic corticosteroids ‐ parallel‐group studies Show forest plot	2	301	Odds Ratio (M‐H, Random, 95% CI)	0.46 [0.18, 1.18]

17 Unscheduled physician visits ‐ parallel‐group studies Show forest plot	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

18 Unscheduled acute care or emergency department visits or need for hospital admission ‐ parallel‐group studies Show forest plot	1	98	Peto Odds Ratio (Peto, Fixed, 95% CI)	8.42 [0.17, 427.40]

19 Unscheduled acute care or emergency department visits or need for hospital admission ‐ cross‐over studies Show forest plot	1	38	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]

20 Duration of exacerbation as defined by time to recovery of lung function Show forest plot	1	207	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

21 Duration of exacerbation as defined by time to recovery of symptoms Show forest plot	1	207	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

22 Non‐serious adverse events Show forest plot	2	142	Odds Ratio (M‐H, Fixed, 95% CI)	2.15 [0.68, 6.73]

23 Non‐serious adverse event ‐ pharyngitis Show forest plot	2	142	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.46 [0.18, 11.58]

24 Non‐serious adverse event ‐ glossitis Show forest plot	2	142	Peto Odds Ratio (Peto, Fixed, 95% CI)	9.36 [0.54, 163.45]

25 Non‐serious adverse event ‐ headaches Show forest plot	1	94	Peto Odds Ratio (Peto, Fixed, 95% CI)	5.36 [0.10, 290.73]

26 Non‐serious adverse event ‐ psychiatric disturbance (depression, anxiety) Show forest plot	1	94	Peto Odds Ratio (Peto, Fixed, 95% CI)	5.36 [0.10, 290.73]

27 Non‐serious adverse event ‐ oral candidiasis	0	0	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
28 Non‐serious adverse event ‐ GI (nausea, abdominal discomfort) Show forest plot	1	94	Odds Ratio (M‐H, Fixed, 95% CI)	2.85 [0.31, 26.51]

29 Non‐serious adverse event ‐ upper respiratory tract infections Show forest plot	1	94	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.33 [0.03, 3.38]

30 Non‐serious adverse event ‐ change in appetite	0	0	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
31 Non‐serious adverse event ‐ dysphonia	0	0	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Maintenance versus increased dose

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