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Cochrane Clinical Answers

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Study flow diagram.
Figures and Tables -
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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Comparison 1 Ciclesonide versus budesonide (dose ratio 1:2), Outcome 1 Patients with exacerbations.
Figures and Tables -
Analysis 1.1

Comparison 1 Ciclesonide versus budesonide (dose ratio 1:2), Outcome 1 Patients with exacerbations.

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Comparison 1 Ciclesonide versus budesonide (dose ratio 1:2), Outcome 2 Quality of life PAQLQ (S).
Figures and Tables -
Analysis 1.2

Comparison 1 Ciclesonide versus budesonide (dose ratio 1:2), Outcome 2 Quality of life PAQLQ (S).

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Comparison 1 Ciclesonide versus budesonide (dose ratio 1:2), Outcome 3 FEV1 least square means (L).
Figures and Tables -
Analysis 1.3

Comparison 1 Ciclesonide versus budesonide (dose ratio 1:2), Outcome 3 FEV1 least square means (L).

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Comparison 2 Ciclesonide versus fluticasone, Outcome 1 Patients with exacerbations.
Figures and Tables -
Analysis 2.1

Comparison 2 Ciclesonide versus fluticasone, Outcome 1 Patients with exacerbations.

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Comparison 2 Ciclesonide versus fluticasone, Outcome 2 Adverse events: number of patients with adverse events.
Figures and Tables -
Analysis 2.2

Comparison 2 Ciclesonide versus fluticasone, Outcome 2 Adverse events: number of patients with adverse events.

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Comparison 2 Ciclesonide versus fluticasone, Outcome 3 Adverse events: 24‐ hour urine free cortisol adjusted for creatinine (nmol/mmol).
Figures and Tables -
Analysis 2.3

Comparison 2 Ciclesonide versus fluticasone, Outcome 3 Adverse events: 24‐ hour urine free cortisol adjusted for creatinine (nmol/mmol).

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Comparison 2 Ciclesonide versus fluticasone, Outcome 4 Generic FEV1 least square mean (L).
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Analysis 2.4

Comparison 2 Ciclesonide versus fluticasone, Outcome 4 Generic FEV1 least square mean (L).

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Summary of findings for the main comparison. Ciclesonide versus budesonide (dose ratio 1:2) for chronic asthma in children

Ciclesonide versus budesonide (dose ratio 1:2) for chronic asthma in children

Patient or population: patients with chronic asthma in children
Settings: all settings
Intervention: ciclesonide
Comparison: budesonide (dose ratio 1:2)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Budesonide (dose ratio 1:2)

Ciclesonide

Asthma symptoms
Asthma symptom score (scale 0 to 4)
Follow‐up: 12 weeks

See comment

See comment

Not estimable

1024
(2 studies)

⊕⊕⊝⊝
low1,2

Both studies used a 5‐point scale, but insufficient data were reported to allow meta‐analysis

Patients with exacerbations
Number of patients with exacerbations
Follow‐up: 12 weeks

12 per 1000

26 per 1000
(9 to 77)

RR 2.2
(0.75 to 6.43)

1024
(2 studies)

⊕⊝⊝⊝
very low1,2,3,4

Adverse events
Number of patients with adverse events
Follow‐up: 12 weeks

See comment

See comment

Not estimable

1024
(2 studies)

⊕⊕⊝⊝
low1,2,3

The data could not be meta‐analysed because the definitions of adverse events were too diverse

*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.

1 In one study the dose of budesonide was much higher than what is commonly prescribed in clinical practice.
2 Both studies were sponsored by the manufacturer and at least one of the authors of each study was an employee of the manufacturer that sponsored the study.
3 The intervention period of 12 weeks was too short to expect any major changes in this outcome.
4 Confidence intervals of estimated effect include no effect and exceed a relative reduction or increase risk of 25%.

Figures and Tables -
Summary of findings for the main comparison. Ciclesonide versus budesonide (dose ratio 1:2) for chronic asthma in children
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Summary of findings 2. Ciclesonide versus fluticasone (dose ratio 1:1) for chronic asthma in children

Ciclesonide versus fluticasone (dose ratio 1:1) for chronic asthma in children

Patient or population: patients with chronic asthma in children
Settings: all settings
Intervention: ciclesonide
Comparison: fluticasone (dose ratio 1:1)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Fluticasone (dose ratio 1:1)

Ciclesonide

Asthma symptoms
Asthma symptom score (scale 0 to 4)
Follow‐up: 12 weeks

See comment

See comment

Not estimable

1468
(3 studies)

⊕⊕⊕⊝
moderate1

2 studies used a 5‐point scale and 1 study did not provide details how asthma symptoms were measured. Data could not be pooled due to diversity in scales

Patients with exacerbations
Number of patients with exacerbations
Follow‐up: 12 weeks

18 per 1000

24 per 1000
(10 to 57)

RR 1.37
(0.58 to 3.21)

1003
(2 studies)

⊕⊝⊝⊝
very low1,2,3

Adverse events
Number of patients with adverse events
Follow‐up: 12 weeks

See comment

See comment

Not estimable

1560
(6 studies)

⊕⊕⊝⊝
low1,2

Adverse events were defined differently across studies therefore results could not be pooled

*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.

1 Two fully published studies were sponsored by the manufacturer and at least one of the authors of each study was an employee of the manufacturer that sponsored the study.
2 The intervention period of 12 weeks is too short to expect any major changes in this outcome.
3 Confidence intervals of estimated effect include no effect and exceed a relative reduction or increase risk of 25%.

Figures and Tables -
Summary of findings 2. Ciclesonide versus fluticasone (dose ratio 1:1) for chronic asthma in children
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Summary of findings 3. Ciclesonide versus fluticasone (dose ratio 1:2) for chronic asthma in children

Ciclesonide versus fluticasone (dose ratio 1:2) for chronic asthma in children

Patient or population: patients with chronic asthma in children
Settings: all settings
Intervention: ciclesonide
Comparison: fluticasone (dose ratio 1:2)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Fluticasone (dose ratio 1:2)

Ciclesonide

Asthma symptom
Asthma symptom score (scale 0 to 4)
Follow‐up: 12 weeks

The mean asthma symptom in the control groups was
1.33

The mean asthma symptom in the intervention groups was
0.07 higher
(0.14 to 0.29 higher)

482
(1 study)

⊕⊕⊝⊝
low1,2

Estimates are medians indicating data was skewed

Patients with exacerbations
Number of patients with exacerbations
Follow‐up: 12 weeks

20 per 1000

70 per 1000
(27 to 174)

RR 3.48
(1.35 to 8.71)

502
(1 study)

⊕⊝⊝⊝
very low1,2,3

Adverse events
Number of patients with adverse events
Follow‐up: 12 weeks

476 per 1000

471 per 1000
(424 to 514)

RR 0.99 (0.89 to 1.08)

502
(1 study)

⊕⊝⊝⊝
very low1,2,3

*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.

1 Based on one study that was underpowered for a non‐inferiority trial.
2 The study was sponsored by the manufacturer and at least one author was an employee of the manufacturer that sponsored the study.
3 The intervention period of 12 weeks is too short to expect any major changes in this outcome.

Figures and Tables -
Summary of findings 3. Ciclesonide versus fluticasone (dose ratio 1:2) for chronic asthma in children
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Table 1. Characteristics of the interventions

Study ID

Ciclesonide dose

Comparator ICS

Application

Inhalation technique

Treatment period

Ciclesonide versus budesonide

von Berg 2007

160 μg OD (ex‐actuator; equivalent to 200 μg ex‐valve) 2 x 80 μg puffs in the evening

Budesonide 400 μg OD 2 x 200 μg puffs

Ciclesonide: HFA‐MDI with an AeroChamber®;

Budesonide: Turbohaler®

Not described

12 weeks

Vermeulen 2007

320 μg OD (ex‐actuator; equivalent to 2 puffs of 200 μg ex‐valve) 2 x 160 μg puffs administered in the evening

Budesonide 800 μg OD (4 inhalations of
200 μg from the Turbohaler® device), administered in the evening

Ciclesonide: HFA‐MDI without spacer Budesonide: Turbohaler®

Not described

12 weeks

Ciclesonide versus fluticasone

Hiremath 2006

160 μg OD

Fluticasone 88 μg BID

MDI with spacer, AeroChamber Plus®

Not described

12 weeks

Paunovic 2010

160 μg OD

Fluticasone 88 μg BID

No information provided

Not described

12 weeks

Pedersen 2006

80 μg BID (ex‐actuator; equivalent to 100 μg BID ex‐valve)

Fluticasone 88 μg BID (ex‐actuator dose, equivalent to 100 μg BID ex‐valve)

HFA‐MDI without spacer

Adequate inhalation technique no details described

12 weeks

Pedersen 2009

80 or 160 μg OD (ex‐actuator; equivalent to 100 and 200 μg ex‐valve) administered in the evening

Fluticasone 88 μg BID (176 ex‐actuator; equivalent to 100 μg BID ex‐valve) in the morning and evening

HFA 134‐MDI without spacer

Good inhalation technique, no details described

12 weeks

BID: twice daily; ex‐actuator: drugs that leaves the inhaler; ex‐valve: drugs that leaves the metering chamber valve; HFA‐MDI: hydrofluoroalkane‐propelled metered dose inhaler; ICS: inhaled corticosteroid; MDI: metered dose inhaler; OD: once daily.

Figures and Tables -
Table 1. Characteristics of the interventions
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Table 2. Effect of the intervention: ciclesonide versus budesonide

Dose

CIC 160 μg OD versus BUD 400 μg OD

CIC 320 μg OD versus BUD 800 μg OD

Dose ratio

1:2

1:2

Study

von Berg 2007

Vermeulen 2007

Primary outcomes

Asthma symptoms: asthma symptom score (sum score)

ITT: MD 0.01, 95% CI ‐0.14 to 0.16

PP: MD 0.03, 95% CI ‐0.20 to 0.25

Non‐inferiority acceptance limit = 0.3

Median change from baseline (no CIs reported)

ITT: CIC: ‐0.07; BUD: ‐0.14

PP: CIC: ‐0.07; BUD: ‐0.14

Asthma symptoms: use of rescue medication (puff/day)

ITT: MD 0.06 puffs/day, 95% CI ‐0.26 to 0.38

Not assessed

Asthma symptoms: % of asthma symptom and rescue medication‐free days

ITT: CIC: mean 73%; BUD: mean 70%

No difference between groups

ITT and PP: CIC: median 84%; BUD: median 85%

Lower limit of the between difference was ‐1.4% and above non‐inferiority limit of ‐8%

Exacerbations: patients with exacerbations*

ITT: RR 2.71, 95% CI 0.61 to 12.11; Analysis 1.1

ITT: RR 1.69, 95% CI 0.36 to 8.00; Analysis 1.1

Adverse events: patients with adverse events

Adverse events were reported in 38% of patients in both groups

ITT: RR** 1.44, 95% CI 0.96 to 2.18

Adverse events: change in body height

Mean change from baseline (least square mean)

CIC: 1.18 cm; BUD: 0.70 cm

Not assessed

Adverse events: 24‐hour urine cortisol adjusted for creatinine

ITT: 2.99 nmol/mmol creatinine; P < 0.0001, one‐sided (decrease greater in the BUD group)

ITT: significant difference between groups (lower level in BUD group)

Secondary outcomes

Quality of life: PAQLQ(S)

ITT: MD ‐0.11, 95% CI ‐0.12 to 0.10, one‐sided superiority; Analysis 1.2

Non‐inferiority acceptance limits = not provided

PP not reported

ITT: MD (least square mean) 0.01, 95% CI ‐0.14 to 0.16; Analysis 1.2

Non‐inferiority acceptance limit = ‐0.5%

PP results were similar

Quality of life: PACQLQ

ITT: MD ‐0.08, 95% CI ‐0.27 to 0.11, one‐sided superiority

Non‐inferiority acceptance limit not provided

PP not reported

Not assessed

Compliance

Not assessed

 Not assessed

Lung function: FEV1 (L)

ITT: MD (least square means) ‐0.019 L, 95% CI ‐0.059 to 0.022; Analysis 1.3

PP: MD (least square means) ‐0.034 L, 95% CI ‐75 to 10

Non‐inferiority acceptance limit = ‐100 mL

ITT: MD (least square means) ‐0.03 L, 95% ‐0.14 to 0.8; Analysis 1.3

PP: MD (least square means) ‐0.02 L, 95% CI ‐0.13 to 0.1

Non‐inferiority acceptance limit = ‐150 mL

Airway inflammation

 Not assessed

Not assessed

BUD: budesonide; CI: confidence interval; CIC: ciclesonide; ITT: intention to treat analysis; MD: mean difference; OD: once daily; PACQLQ: Pediatric Asthma Caregiver Quality of Life Questionnaire; PAQLQ: Pediatric Asthma Quality of Life Questionnaire; PP: per protocol; RR: risk ratio.

* Exacerbations were defined as an increasing asthma symptoms requiring change or addition of patient's medication other than increasing rescue medication.

** Adverse events that needed treatment, reported in over 2% of patients in CIC or BUD group of safety population (N = 403).

Figures and Tables -
Table 2. Effect of the intervention: ciclesonide versus budesonide
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Table 3. Effects of the intervention: ciclesonide versus fluticasone

Dose

CIC 80 μg BID vs. FP 88 μg BID

CIC 160 μg OD vs. FP 88 μg BID

CIC 80 μg BID vs. FP 88 μg BID

CIC 160 μg OD vs. FP 88 μg BID

CIC 80 μg OD vs. FP 88 μg BID

Dose ratio

1:1

1:1

1:1

1:1

1:2

Study

Pedersen 2006

Pedersen 2009

Hiremath 2006

Paunovic 2010

Pedersen 2009

Primary outcomes

Asthma symptoms: asthma symptom score

Median difference (Hodges Lehmann point estimate)

ITT and PP:

0.00, 95% CI ‐0.29 to 0.14

Median difference (Hodges Lehmann point estimate)

Unclear if ITT or PP *:

0.07, 95% CI ‐0.14 to 0.28

Non‐inferiority acceptance limit = 0.30 sum score

Not assessed

Asthma symptom score decreased and was similar in both groups

Median difference (Hodges Lehmann point estimate)

Unclear if ITT or PP **:

0.07, 95% CI ‐0.14 to 0.28

Non‐inferiority acceptance limit = 0.30 sum score

Asthma symptoms: use of rescue medication

Median difference (Hodges Lehmann point estimate)

ITT and PP: 0.00, 95% CI ‐1.23 to 2.12

Median change from baseline (Hodges Lehmann point estimate)

ITT: CIC: ‐1.13; FP: ‐1.29

PP: CIC: ‐1.14; FP: ‐1.29

All P < 0.0001

Not assessed

Use of rescue medication decreased and was similar in both groups

Median change from baseline (Hodges Lehmann point estimate)

ITT: CIC: ‐1.20; FP: ‐1.29

PP: CIC: ‐1.21; FP: ‐1.29

All P < 0.0001

Asthma symptoms: a sthma symptom‐free days

Median difference (Hodges Lehmann point estimate)

ITT: ‐1.01, 95% CI ‐4.60 to 2.46

PP: ‐1.01, 95% CI ‐4.82 to 2.51

Not assessed

Not assessed

Not assessed

Not assessed

Asthma symptoms: % of asthma symptom and rescue medication‐free days combined

Not assessed

Mean percentage was high and did not differ significantly between the treatment groups (PP)

Median

CIC: 91.5%; FP: 94%

P = 0.1320 (2‐sided between treatments)

Not assessed

PP: mean percentage was high and did not differ between the treatment groups

Exacerbations: number of patients with exacerbations

RR 1.26, 95% CI 0.34 to 4.66; Analysis 2.1

RR 1.45, 95% CI 0.47 to 4.49; Analysis 2.1

Not assessed

CIC: 2.3%; FP: 2.2%

RR 3.57, 95% CI 1.35 to 9.47; Analysis 2.1

Adverse events: % of patients with adverse events

A similar percentage of patients reported adverse events

RR 0.88, 95% CI 0.72 to 1.07; Analysis 2.2

The incidence of adverse events was similar in both groups

Not assessed

RR 0.98, 95% CI 0.81 to 1.17; Analysis 2.2

Adverse events: cortisol 24‐hour urine sample (nmol/mmol)

ITT: difference between 2 groups was not statistically significant

ITT and restricted ITT

(which included only

those urine cortisol

measurements with a

corresponding urine

creatinine value within

the normal range)

A statistically significant

difference in favour of CIC was seen in the restricted ITT analysis

(P = 0.006). The findings were similar

for patients who were ICS‐naive and patients who had received ICS prior to study entry

although the differences were numerically greater in previously ICS‐naive patients

Safety analysis**: MD

0.54 nmol/mmol, 95% CI ‐5.92 to 7.00; Analysis 2.3

Not assessed

Not assessed

Safety analysis**: MD 1.15 nmol/mmol, 95% CI 0.07 to 2.23; Analysis 2.3

Secondary outcomes

Quality of life: PAQLQ

Not assessed

ITT and PP:

Non‐inferiority was confirmed CIC 160 compared to FP (P < 0.0001, one‐sided)

Non‐inferiority limit = ‐0.5

Not assessed

Not assessed

ITT and PP:

Non‐inferiority was confirmed for CIC80 compared to FP (P < 0.0001, one‐sided)

Non‐inferiority limit = ‐0.5

Quality of life: PACQLQ

Not assessed

ITT and PP:

Non‐inferiority was confirmed CIC 160 compared to FP (P < 0.0001, one‐sided)

Non‐inferiority limit = 15

Not assessed

Not assessed

ITT and PP:

Non‐inferiority was confirmed for CIC80 compared to FP (P < 0.0001, one‐sided)

Non‐inferiority limit = 15

Compliance

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

Change in lung function:

FEV1 (L)

ITT: MD (least square means) 0.0 L, 95% CI ‐0.042 to 0.042; Analysis 2.4

PP: MD (least square means) 0.001, 95% ‐0.044 to 0.046

ITT: MD (least square means) ‐0.02 L, 95% CI ‐0.07 to 0.04; Analysis 2.4

PP: MD (least square means) ‐0.026, 95% CI ‐0.086 to 0.34

Improvement similar between groups no point estimates

Improvement similar between groups no point estimates

ITT: MD (least square means) ‐0.05 L, 95% CI ‐0.11 to 0.01; Analysis 2.4

PP: MD (least square means) ‐0.056, 95% CI ‐0.12 to ‐0.004

Airway inflammation

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

BID: twice daily; CI: confidence interval; CIC: ciclesonide; FP: fluticasone; ICS: inhaled corticosteroid; ITT: intention to treat analysis; OD: once daily; PACQLQ: Pediatric Asthma Caregiver Quality of Life Questionnaire; PAQLQ: Pediatric Asthma Quality of Life Questionnaire; PP: per protocol analysis.

* = In this study analyses were based on PP population and analysis of ITT population was used to confirm results, description of the results are unclear but we assumed it to be based on analysis of PP population.

** = safety analysis excluded patients with concurrent nasal, ophthalmological or dermatological corticosteroid treatment.

Figures and Tables -
Table 3. Effects of the intervention: ciclesonide versus fluticasone
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Comparison 1. Ciclesonide versus budesonide (dose ratio 1:2)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Patients with exacerbations Show forest plot

2

1024

Risk Ratio (M‐H, Fixed, 95% CI)

2.20 [0.75, 6.43]

2 Quality of life PAQLQ (S) Show forest plot

2

1010

Mean Difference (IV, Fixed, 95% CI)

‐0.00 [‐0.09, 0.09]

3 FEV1 least square means (L) Show forest plot

2

1021

Mean Difference (IV, Fixed, 95% CI)

‐0.02 [‐0.10, 0.05]
Figures and Tables -
Comparison 1. Ciclesonide versus budesonide (dose ratio 1:2)
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Comparison 2. Ciclesonide versus fluticasone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Patients with exacerbations Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Dose ratio 1:1

2

1003

Risk Ratio (M‐H, Fixed, 95% CI)

1.37 [0.58, 3.21]

1.2 Dose ratio 1:2

1

502

Risk Ratio (M‐H, Fixed, 95% CI)

3.57 [1.35, 9.47]

2 Adverse events: number of patients with adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Dose ratio 1:1

1

492

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.72, 1.07]

2.2 Dose ratio 1:2

1

502

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.81, 1.17]

3 Adverse events: 24‐ hour urine free cortisol adjusted for creatinine (nmol/mmol) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 Dose ratio 1:1

1

492

Mean Difference (IV, Fixed, 95% CI)

0.54 [‐5.92, 7.00]

3.2 Dose ratio 1:2

1

502

Mean Difference (IV, Fixed, 95% CI)

1.15 [0.07, 2.23]

4 Generic FEV1 least square mean (L) Show forest plot

2

Mean Difference (Fixed, 95% CI)

Subtotals only

4.1 Dose ratio 1:1

2

1000

Mean Difference (Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

4.2 Dose ratio 1:2

1

499

Mean Difference (Fixed, 95% CI)

‐0.05 [‐0.11, 0.01]
Figures and Tables -
Comparison 2. Ciclesonide versus fluticasone
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