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Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 Leukotriene receptor antagonists + ICS versus Long‐acting β2‐agonists + ICS, outcome: 1.1 Participants with one or more exacerbations requiring systemic corticosteroids.
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 Leukotriene receptor antagonists + ICS versus Long‐acting β2‐agonists + ICS, outcome: 1.1 Participants with one or more exacerbations requiring systemic corticosteroids.

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In the LRTA + ICS group, 13 out of 100 people had one or more exacerbations requiring OCS over four to 102 weeks, compared with 11 (95% CI 10 to 12) of 100 for the LABA + ICS group.
Figuras y tablas -
Figure 4

In the LRTA + ICS group, 13 out of 100 people had one or more exacerbations requiring OCS over four to 102 weeks, compared with 11 (95% CI 10 to 12) of 100 for the LABA + ICS group.

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Funnel plot of comparison: 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, outcome: 1.1 Participants with one or more exacerbations requiring systemic corticosteroids.
Figuras y tablas -
Figure 5

Funnel plot of comparison: 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, outcome: 1.1 Participants with one or more exacerbations requiring systemic corticosteroids.

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In the LRTA + ICS group, two of 100 people had serious adverse events over 4 to 102 weeks, compared with three (95% CI 2 to 4) of 100 for the LABA + ICS group.
Figuras y tablas -
Figure 6

In the LRTA + ICS group, two of 100 people had serious adverse events over 4 to 102 weeks, compared with three (95% CI 2 to 4) of 100 for the LABA + ICS group.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 1 Participants with one or more exacerbations requiring systemic corticosteroids.
Figuras y tablas -
Analysis 1.1

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 1 Participants with one or more exacerbations requiring systemic corticosteroids.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 2 Morning PEF: L/min change from baseline.
Figuras y tablas -
Analysis 1.2

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 2 Morning PEF: L/min change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 3 Evening PEF: L/min change from baseline.
Figuras y tablas -
Analysis 1.3

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 3 Evening PEF: L/min change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 4 FEV1: L, % change from baseline.
Figuras y tablas -
Analysis 1.4

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 4 FEV1: L, % change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 5 % fall in FEV1 postexercise.
Figuras y tablas -
Analysis 1.5

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 5 % fall in FEV1 postexercise.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 6 FEV1: L, % change from baseline.
Figuras y tablas -
Analysis 1.6

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 6 FEV1: L, % change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 7 FEV1: % of predicted end of treatment.
Figuras y tablas -
Analysis 1.7

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 7 FEV1: % of predicted end of treatment.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 8 Rescue‐free days: % change from baseline.
Figuras y tablas -
Analysis 1.8

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 8 Rescue‐free days: % change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 9 Rescue medication use: puffs/d change from baseline.
Figuras y tablas -
Analysis 1.9

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 9 Rescue medication use: puffs/d change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 10 Global asthma QoL AQLQ score (higher is better): change from baseline.
Figuras y tablas -
Analysis 1.10

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 10 Global asthma QoL AQLQ score (higher is better): change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 11 Symptom‐free days: % change from baseline.
Figuras y tablas -
Analysis 1.11

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 11 Symptom‐free days: % change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 12 Daytime symptom scores (high is worse): change from baseline.
Figuras y tablas -
Analysis 1.12

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 12 Daytime symptom scores (high is worse): change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 13 Morning symptoms: change from baseline.
Figuras y tablas -
Analysis 1.13

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 13 Morning symptoms: change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 14 Night‐time symptom score (five‐point scale, higher score is worse): change from baseline.
Figuras y tablas -
Analysis 1.14

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 14 Night‐time symptom score (five‐point scale, higher score is worse): change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 15 Change in number of night awakenings per week: change from baseline.
Figuras y tablas -
Analysis 1.15

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 15 Change in number of night awakenings per week: change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 16 Change in % of nights with no awakenings per week: change from baseline.
Figuras y tablas -
Analysis 1.16

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 16 Change in % of nights with no awakenings per week: change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 17 Rescue‐free nights (%): change from baseline.
Figuras y tablas -
Analysis 1.17

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 17 Rescue‐free nights (%): change from baseline.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 18 Withdrawals for any reason.
Figuras y tablas -
Analysis 1.18

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 18 Withdrawals for any reason.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 19 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 1.19

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 19 Withdrawals due to adverse events.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 20 Withdrawals due to poor asthma control/asthma exacerbation.
Figuras y tablas -
Analysis 1.20

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 20 Withdrawals due to poor asthma control/asthma exacerbation.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 21 Participants with one or more exacerbations requiring hospital admission.
Figuras y tablas -
Analysis 1.21

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 21 Participants with one or more exacerbations requiring hospital admission.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 22 Serious adverse events.
Figuras y tablas -
Analysis 1.22

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 22 Serious adverse events.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 23 Death.
Figuras y tablas -
Analysis 1.23

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 23 Death.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 24 Headache.
Figuras y tablas -
Analysis 1.24

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 24 Headache.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 25 Cardiovascular events.
Figuras y tablas -
Analysis 1.25

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 25 Cardiovascular events.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 26 Oral moniliasis.
Figuras y tablas -
Analysis 1.26

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 26 Oral moniliasis.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 27 Osteopenia/osteoporosis.
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Analysis 1.27

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 27 Osteopenia/osteoporosis.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 28 Elevated liver enzymes.
Figuras y tablas -
Analysis 1.28

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 28 Elevated liver enzymes.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 29 Overall adverse events.
Figuras y tablas -
Analysis 1.29

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 29 Overall adverse events.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 30 Participants' treatment satisfaction.
Figuras y tablas -
Analysis 1.30

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 30 Participants' treatment satisfaction.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 31 Participants switched/received additional treatment.
Figuras y tablas -
Analysis 1.31

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 31 Participants switched/received additional treatment.

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Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 32 Change from baseline in serum eosinophils (× 109/L).
Figuras y tablas -
Analysis 1.32

Comparison 1 Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS, Outcome 32 Change from baseline in serum eosinophils (× 109/L).

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Comparison 2 Subgroup and sensitivity analyses, Outcome 1 Participants with one or more exacerbations requiring systemic corticosteroids: number of inhaler devices.
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Analysis 2.1

Comparison 2 Subgroup and sensitivity analyses, Outcome 1 Participants with one or more exacerbations requiring systemic corticosteroids: number of inhaler devices.

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Comparison 2 Subgroup and sensitivity analyses, Outcome 2 Participants with one or more exacerbations requiring systemic corticosteroids: dose of ICS.
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Analysis 2.2

Comparison 2 Subgroup and sensitivity analyses, Outcome 2 Participants with one or more exacerbations requiring systemic corticosteroids: dose of ICS.

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Comparison 2 Subgroup and sensitivity analyses, Outcome 3 Participants with one or more exacerbations requiring systemic corticosteroids: study duration.
Figuras y tablas -
Analysis 2.3

Comparison 2 Subgroup and sensitivity analyses, Outcome 3 Participants with one or more exacerbations requiring systemic corticosteroids: study duration.

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Comparison 2 Subgroup and sensitivity analyses, Outcome 4 Participants with one or more exacerbations requiring systemic corticosteroids: LTRA.
Figuras y tablas -
Analysis 2.4

Comparison 2 Subgroup and sensitivity analyses, Outcome 4 Participants with one or more exacerbations requiring systemic corticosteroids: LTRA.

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Comparison 2 Subgroup and sensitivity analyses, Outcome 5 Serious adverse events stratified by number of inhaler devices used for LABA + ICS.
Figuras y tablas -
Analysis 2.5

Comparison 2 Subgroup and sensitivity analyses, Outcome 5 Serious adverse events stratified by number of inhaler devices used for LABA + ICS.

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Comparison 2 Subgroup and sensitivity analyses, Outcome 6 Serious adverse events stratified by age of participants (adults vs children).
Figuras y tablas -
Analysis 2.6

Comparison 2 Subgroup and sensitivity analyses, Outcome 6 Serious adverse events stratified by age of participants (adults vs children).

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Comparison 3 MD archive from previous review version, Outcome 1 Morning PEF (L/min): change from baseline.
Figuras y tablas -
Analysis 3.1

Comparison 3 MD archive from previous review version, Outcome 1 Morning PEF (L/min): change from baseline.

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Comparison 3 MD archive from previous review version, Outcome 2 Evening PEF (L/min): change from baseline.
Figuras y tablas -
Analysis 3.2

Comparison 3 MD archive from previous review version, Outcome 2 Evening PEF (L/min): change from baseline.

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Comparison 3 MD archive from previous review version, Outcome 3 FEV1 (L): change from baseline.
Figuras y tablas -
Analysis 3.3

Comparison 3 MD archive from previous review version, Outcome 3 FEV1 (L): change from baseline.

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Comparison 3 MD archive from previous review version, Outcome 4 Symptom‐free days (%): change from baseline.
Figuras y tablas -
Analysis 3.4

Comparison 3 MD archive from previous review version, Outcome 4 Symptom‐free days (%): change from baseline.

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Summary of findings for the main comparison. LABA + ICS compared with LTRA + ICS for chronic asthma

LABA + ICS compared with LTRA + ICS for chronic asthma

Patient or population: patients with chronic asthma
Settings: outpatients
Intervention: LABA + ICS
Comparison: LTRA + ICS

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

LTRA + ICS

LABA + ICS

Participants with one or more exacerbations requiring systemic corticosteroids
Follow‐up: 4 to 102 weeks

126 per 1000

109 per 1000
(96 to 125)

RR 0.87
(0.76 to 0.99)

6257
(8 studies)

⊕⊕⊕⊕
high

Adults are overrepresented, with 5923 adults and 334 children

Morning PEFR: L/min change from baseline
Follow‐up: 4 to 48 weeks

Data were presented as generic inverse variance

Mean morning PEFR: L/min change from baseline in anti‐leukotrienes versus long‐acting beta2 agonists in the intervention groups was
15.36 higher
(11.35 to 19.37 higher)

6161
(11 studies)

⊕⊕⊕⊝
moderate1

FEV1: L change from baseline
Follow‐up: 4 to 48 weeks

Data were presented as generic inverse variance

Mean FEV1: change from baseline with LABA + ICS was
0.08 L higher
(0.05 to 0.1 higher)

4999
(10 studies)

⊕⊕⊕⊕
high

Rescue‐free days: % change from baseline
Follow‐up: 4 to 12 weeks

Mean rescue‐free days: % change from baseline with LRTA + ICS was
22.58% change from baseline

Mean rescue‐free days: % change from baseline with LABA + ICS was
9.18% higher
(5.39 to 12.98 higher)

2612
(5 studies)

⊕⊕⊕⊝
moderate1

Rescue medication use: puffs/d change from baseline
Follow‐up: 4 to 48 weeks

1.9 lower use of puffs per day

Mean rescue medication use: puffs/d change from baseline in the intervention groups was
0.49 lower
(0.75 to 0.24 lower)

4055
(7 studies)

⊕⊕⊕⊕
high

Withdrawals for any reason
Follow‐up: 4 to 48 weeks

133 per 1000

111 per 1000
(98 to 127)

RR 0.84
(0.74 to 0.96)

6960
(13 studies)

⊕⊕⊕⊝
moderate1

Serious adverse events
Follow‐up: 4 to 48 weeks

23 per 1000

31 per 1000
(23 to 41)

RR 1.33
(0.99 to 1.79)

6288
(9 studies)

⊕⊕⊕⊝
moderate1

*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; RR: Risk 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.

1Grosclaude 2003 was an open‐label study.

Figuras y tablas -
Summary of findings for the main comparison. LABA + ICS compared with LTRA + ICS for chronic asthma
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Table 1. Search history

Years

Detail

All years to January 2004

Citations: 184 (181 from the literature search and three unpublished trials provided by pharmaceutical companies for a total of 184 citations)

Citations excluded: 172: (1) duplicate citations (N = 29), (2) abstracts of considered full‐text publications or secondary analyses of the same study (N = 18), (3) not a randomised controlled trial (N = 72), (4) protocol of ongoing trial (N = 1), (5) no consistent co‐treatment with ICS (N = 21), (6) one of the tested interventions was not daily LTRA (N = 18), (7) one of the tested interventions was not daily LABA (N = 5), (8) interventions were administered for less than four weeks (N = 6), and (9) use of prohibited co‐interventions such as LABA in both groups (N = 2)

Studies meeting the entry criteria of the review: 12 (six full‐text publications (Bjermer 2003; Fish 2001; Ilowite 2004; Nelson 2000; Nelson 2001; Ringdal 2003), two unpublished full‐text reports (Hultquist 2000; McCarthy 2003) and four abstracts (Gold 2001 (abs); Green (abs) 2002; Leibman (abs) 2002; Nsouli 2001). The abstracts did not provide data in sufficient detail to contribute to the meta‐analyses

January 2004 to January 2006

Citations: 60

Citations excluded: 55: The study was a duplicate (i.e. identical citation of one trial report or a subsequent report of a trial) (N = 22); the study was not randomised (N = 2); the study was ongoing (N = 5); the administration of LTRA or LABA was not standardised across treatment groups (N = 3); no consistent co‐treatment with ICS was provided (N = 8); one of the tested interventions was not daily LTRA as add‐on to ICS (N = 9); one of the tested interventions was not daily LABA as add‐on to ICS (N = 2); the tested interventions were administered for less than four weeks (N = 1); the study used prohibited co‐intervention (i.e. maintenance oral steroids, theophylline, non‐steroidal anti‐inflammatory drugs, anticholinergics) (N = 3)

Figuras y tablas -
Table 1. Search history
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Table 2. ICS at CFC‐BDP equivalent dose (µg/d)

Study

Actual dose of ICS (total per day)

CFC‐ BDP equivalent/d

Population

Low/medium/high

Basu 2011

Fluticasone; dose not specified

Not specified

Children

Unclear

Bjermer 2003

200 μg fluticasone

400 μg

Adults

Low

Ceylan 2004

400 μg budesonide

400 μg

Adults

Low

Fish 2001

Range of doses between 175 and 1700 μg

560 µg (range 175 to 1700)

Adults

Mixed

Fogel 2010

200 μg fluticasone

400 μg

Children

Low

Gold 2001

100 μg fluticasone

200 μg

Adults

Low

Green 2006

200 μg budesonide

200 μg

Adults

Low

Grosclaude 2003

1000 μg CFC‐BDP and fluticasone 500 μg

1000 μg

Adults

High

Hendeles 2004

250 μg fluticasone

500 μg

Adults

Medium

Ilowite 2004

250 μg fluticasone

500 μg

Adults

Medium

Lemanske 2010

200 μg fluticasone

400 μg

Children

Low

Nelson 2000

200 μg fluticasone

400 μg

Adults

Low

Nelson 2001

Not specified

Requested from author 08/03

Adults

Unclear

Nsouli 2001

Unclear

500 μg

Adults

Unclear

Pavord 2007

200 μg fluticasone

400 μg

Adults

Low

Ringdal 2003

200 μg fluticasone

400 μg

Adults

Low

SAM40030

200 μg fluticasone

400 μg

Adults

Low

SD‐004‐0216

400 μg budesonide

400 μg

Adults

Low

Price 2011

Beclomethasone, budesonide, fluticasone

Not specified

Adults

Unclear

Storms 2004

200 μg fluticasone

400 μg

Adults

Low
Figuras y tablas -
Table 2. ICS at CFC‐BDP equivalent dose (µg/d)
Ir a la tabla de la revisión
Comparison 1. Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with one or more exacerbations requiring systemic corticosteroids Show forest plot

8

6257

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.76, 0.99]

1.1 Adults

7

5923

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.76, 1.00]

1.2 Children

1

334

Risk Ratio (M‐H, Fixed, 95% CI)

0.84 [0.53, 1.34]

2 Morning PEF: L/min change from baseline Show forest plot

11

Mean Difference (Random, 95% CI)

15.36 [11.35, 19.37]

2.1 Adults

11

Mean Difference (Random, 95% CI)

15.36 [11.35, 19.37]

3 Evening PEF: L/min change from baseline Show forest plot

10

Mean Difference (Random, 95% CI)

12.64 [10.11, 15.17]

3.1 Adults

10

Mean Difference (Random, 95% CI)

12.64 [10.11, 15.17]

4 FEV1: L, % change from baseline Show forest plot

10

Mean Difference (Random, 95% CI)

0.08 [0.05, 0.10]

4.1 Adults

10

Mean Difference (Random, 95% CI)

0.08 [0.05, 0.10]

5 % fall in FEV1 postexercise Show forest plot

2

358

Mean Difference (IV, Fixed, 95% CI)

3.07 [0.68, 5.47]

5.1 Adults

1

70

Mean Difference (IV, Fixed, 95% CI)

2.8 [‐1.48, 7.08]

5.2 Children

1

288

Mean Difference (IV, Fixed, 95% CI)

3.20 [0.31, 6.09]

6 FEV1: L, % change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6.1 Adults

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 FEV1: % of predicted end of treatment Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7.1 Adults

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 Rescue‐free days: % change from baseline Show forest plot

5

2612

Mean Difference (IV, Random, 95% CI)

9.18 [5.39, 12.98]

8.1 Adults

5

2612

Mean Difference (IV, Random, 95% CI)

9.18 [5.39, 12.98]

9 Rescue medication use: puffs/d change from baseline Show forest plot

7

4055

Mean Difference (IV, Random, 95% CI)

‐0.49 [‐0.75, ‐0.24]

9.1 Adults

7

4055

Mean Difference (IV, Random, 95% CI)

‐0.49 [‐0.75, ‐0.24]

10 Global asthma QoL AQLQ score (higher is better): change from baseline Show forest plot

4

3243

Std. Mean Difference (IV, Random, 95% CI)

0.12 [0.05, 0.19]

10.1 Adults

4

3243

Std. Mean Difference (IV, Random, 95% CI)

0.12 [0.05, 0.19]

11 Symptom‐free days: % change from baseline Show forest plot

6

Mean Difference (Random, 95% CI)

7.09 [3.66, 10.52]

11.1 Adults

6

Mean Difference (Random, 95% CI)

7.09 [3.66, 10.52]

12 Daytime symptom scores (high is worse): change from baseline Show forest plot

5

3823

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.18 [‐0.25, ‐0.12]

12.1 Adults

5

3823

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.18 [‐0.25, ‐0.12]

13 Morning symptoms: change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

13.1 Adults

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14 Night‐time symptom score (five‐point scale, higher score is worse): change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

14.1 Adults

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

15 Change in number of night awakenings per week: change from baseline Show forest plot

4

4214

Mean Difference (IV, Fixed, 95% CI)

‐0.12 [‐0.19, ‐0.06]

15.1 Adults

4

4214

Mean Difference (IV, Fixed, 95% CI)

‐0.12 [‐0.19, ‐0.06]

16 Change in % of nights with no awakenings per week: change from baseline Show forest plot

2

673

Mean Difference (IV, Fixed, 95% CI)

6.89 [2.87, 10.91]

16.1 Adults

2

673

Mean Difference (IV, Fixed, 95% CI)

6.89 [2.87, 10.91]

17 Rescue‐free nights (%): change from baseline Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

17.1 Adults

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18 Withdrawals for any reason Show forest plot

13

6960

Risk Ratio (M‐H, Fixed, 95% CI)

0.84 [0.74, 0.96]

18.1 Adults

12

6652

Risk Ratio (M‐H, Fixed, 95% CI)

0.84 [0.74, 0.95]

18.2 Children

1

308

Risk Ratio (M‐H, Fixed, 95% CI)

1.25 [0.34, 4.57]

19 Withdrawals due to adverse events Show forest plot

12

6591

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.79, 1.29]

19.1 Adults

11

6291

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.79, 1.29]

19.2 Children

1

300

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

20 Withdrawals due to poor asthma control/asthma exacerbation Show forest plot

8

5354

Risk Ratio (M‐H, Random, 95% CI)

0.87 [0.49, 1.56]

20.1 Adults

8

5354

Risk Ratio (M‐H, Random, 95% CI)

0.87 [0.49, 1.56]

21 Participants with one or more exacerbations requiring hospital admission Show forest plot

6

4675

Risk Ratio (M‐H, Fixed, 95% CI)

1.34 [0.68, 2.67]

21.1 Adults

5

4345

Risk Ratio (M‐H, Fixed, 95% CI)

1.37 [0.67, 2.79]

21.2 Children

1

330

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.06, 15.85]

22 Serious adverse events Show forest plot

9

6288

Risk Ratio (M‐H, Fixed, 95% CI)

1.33 [0.99, 1.79]

22.1 Adults

7

5658

Risk Ratio (M‐H, Fixed, 95% CI)

1.35 [1.00, 1.82]

22.2 Children

2

630

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.20, 4.91]

23 Death Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

23.1 Adults

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

24 Headache Show forest plot

10

6187

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.90, 1.26]

24.1 Adults

10

6187

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.90, 1.26]

25 Cardiovascular events Show forest plot

5

5163

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.77, 1.53]

25.1 Adults

5

5163

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.77, 1.53]

26 Oral moniliasis Show forest plot

6

5203

Risk Ratio (M‐H, Fixed, 95% CI)

1.86 [1.00, 3.44]

26.1 Adults

6

5203

Risk Ratio (M‐H, Fixed, 95% CI)

1.86 [1.00, 3.44]

27 Osteopenia/osteoporosis Show forest plot

2

2963

Risk Ratio (M‐H, Fixed, 95% CI)

0.56 [0.12, 2.63]

27.1 Adults

2

2963

Risk Ratio (M‐H, Fixed, 95% CI)

0.56 [0.12, 2.63]

28 Elevated liver enzymes Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

28.1 Adults

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

29 Overall adverse events Show forest plot

10

6277

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.99, 1.06]

29.1 Adults

9

5977

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.99, 1.07]

29.2 Children

1

300

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.47, 1.31]

30 Participants' treatment satisfaction Show forest plot

3

2020

Risk Ratio (M‐H, Random, 95% CI)

1.12 [1.04, 1.20]

30.1 Adults

3

2020

Risk Ratio (M‐H, Random, 95% CI)

1.12 [1.04, 1.20]

31 Participants switched/received additional treatment Show forest plot

1

342

Risk Ratio (M‐H, Random, 95% CI)

0.01 [0.00, 0.16]

31.1 Adults

1

342

Risk Ratio (M‐H, Random, 95% CI)

0.01 [0.00, 0.16]

32 Change from baseline in serum eosinophils (× 109/L) Show forest plot

2

2787

Mean Difference (IV, Fixed, 95% CI)

0.04 [0.02, 0.05]

32.1 Adults

2

2787

Mean Difference (IV, Fixed, 95% CI)

0.04 [0.02, 0.05]
Figuras y tablas -
Comparison 1. Long‐acting β2‐agonists + ICS versus leukotriene receptor antagonists + ICS
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Comparison 2. Subgroup and sensitivity analyses

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with one or more exacerbations requiring systemic corticosteroids: number of inhaler devices Show forest plot

8

6257

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.76, 0.99]

1.1 Single device for LABA + ICS

3

1586

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.45, 0.91]

1.2 Two devices for LABA + ICS

4

4319

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.75, 1.04]

1.3 Single device or two separate devices for LABA + ICS

1

352

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.80, 1.41]

2 Participants with one or more exacerbations requiring systemic corticosteroids: dose of ICS Show forest plot

8

6257

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.76, 0.99]

2.1 Low dose of ICS

4

3076

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.66, 0.98]

2.2 Medium dose of ICS

1

1452

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.67, 1.08]

2.3 Mixed

1

948

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.50, 1.96]

2.4 Unclear

2

781

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.79, 1.37]

3 Participants with one or more exacerbations requiring systemic corticosteroids: study duration Show forest plot

8

6257

Risk Ratio (M‐H, Random, 95% CI)

0.88 [0.77, 1.01]

3.1 12 weeks or less

4

2629

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.43, 1.02]

3.2 ≥ 48 weeks

4

3628

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.80, 1.05]

4 Participants with one or more exacerbations requiring systemic corticosteroids: LTRA Show forest plot

8

6257

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.76, 0.99]

4.1 Montelukast 5 mg or 10 mg once daily

6

5476

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.72, 0.97]

4.2 Zafirlukast 20 mg twice daily

1

429

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.29, 2.52]

4.3 Monterlukast 10 mg once daily or zafirlukast 20 mg twice daily

1

352

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.80, 1.41]

5 Serious adverse events stratified by number of inhaler devices used for LABA + ICS Show forest plot

9

6288

Risk Ratio (M‐H, Fixed, 95% CI)

1.33 [0.99, 1.79]

5.1 Single device for LABA + ICS

4

1648

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.35, 1.94]

5.2 Two devices for LABA + ICS

5

4640

Risk Ratio (M‐H, Fixed, 95% CI)

1.42 [1.04, 1.95]

6 Serious adverse events stratified by age of participants (adults vs children) Show forest plot

9

6288

Risk Ratio (M‐H, Fixed, 95% CI)

1.33 [0.99, 1.79]

6.1 Adults

7

5658

Risk Ratio (M‐H, Fixed, 95% CI)

1.35 [1.00, 1.82]

6.2 Children

2

630

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.20, 4.91]
Figuras y tablas -
Comparison 2. Subgroup and sensitivity analyses
Ir a la tabla de la revisión
Comparison 3. MD archive from previous review version

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Morning PEF (L/min): change from baseline Show forest plot

10

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2 Evening PEF (L/min): change from baseline Show forest plot

9

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3 FEV1 (L): change from baseline Show forest plot

8

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4 Symptom‐free days (%): change from baseline Show forest plot

5

Mean Difference (IV, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 3. MD archive from previous review version
Ir a la tabla de la revisión