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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 1

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

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 1 Change in FEV1 (Litres).
Figuras y tablas -
Analysis 1.1

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 1 Change in FEV1 (Litres).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 2 Change in FEV1 % predicted.
Figuras y tablas -
Analysis 1.2

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 2 Change in FEV1 % predicted.

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 3 Change in morning PEFR compared to baseline (L/min).
Figuras y tablas -
Analysis 1.3

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 3 Change in morning PEFR compared to baseline (L/min).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 4 Change in PEFR predicted (%).
Figuras y tablas -
Analysis 1.4

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 4 Change in PEFR predicted (%).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 5 Beta‐agonist use (puffs/day).
Figuras y tablas -
Analysis 1.5

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 5 Beta‐agonist use (puffs/day).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 6 Beta‐agonist use (% reduction in days using beta‐agonist).
Figuras y tablas -
Analysis 1.6

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 6 Beta‐agonist use (% reduction in days using beta‐agonist).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 7 Change in rescue medication usage (Juniper questionnaire item 6).
Figuras y tablas -
Analysis 1.7

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 7 Change in rescue medication usage (Juniper questionnaire item 6).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 8 Change in asthma‐free days per week.
Figuras y tablas -
Analysis 1.8

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 8 Change in asthma‐free days per week.

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 9 Change in % days without asthma symptoms.
Figuras y tablas -
Analysis 1.9

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 9 Change in % days without asthma symptoms.

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 10 Change in heath‐related quality of life (AQLQ).
Figuras y tablas -
Analysis 1.10

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 10 Change in heath‐related quality of life (AQLQ).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 11 Change in health‐related quality of life (ACQ).
Figuras y tablas -
Analysis 1.11

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 11 Change in health‐related quality of life (ACQ).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 12 Withdrawals (any reason).
Figuras y tablas -
Analysis 1.12

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 12 Withdrawals (any reason).

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 13 Dysphonia.
Figuras y tablas -
Analysis 1.13

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 13 Dysphonia.

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 14 Headache.
Figuras y tablas -
Analysis 1.14

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 14 Headache.

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 15 Increased asthma symptoms.
Figuras y tablas -
Analysis 1.15

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 15 Increased asthma symptoms.

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 16 Oral candidiasis.
Figuras y tablas -
Analysis 1.16

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 16 Oral candidiasis.

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 17 Any adverse event.
Figuras y tablas -
Analysis 1.17

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 17 Any adverse event.

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 18 Admission to hospital for asthma.
Figuras y tablas -
Analysis 1.18

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 18 Admission to hospital for asthma.

Comparison 2 FP versus HFA‐BDP (dose ratio 1:1; crossover trials), Outcome 1 FEV1 (predicted).
Figuras y tablas -
Analysis 2.1

Comparison 2 FP versus HFA‐BDP (dose ratio 1:1; crossover trials), Outcome 1 FEV1 (predicted).

Comparison 2 FP versus HFA‐BDP (dose ratio 1:1; crossover trials), Outcome 2 Morning PEFR.
Figuras y tablas -
Analysis 2.2

Comparison 2 FP versus HFA‐BDP (dose ratio 1:1; crossover trials), Outcome 2 Morning PEFR.

Comparison 2 FP versus HFA‐BDP (dose ratio 1:1; crossover trials), Outcome 3 Asthma Control Questionnaire.
Figuras y tablas -
Analysis 2.3

Comparison 2 FP versus HFA‐BDP (dose ratio 1:1; crossover trials), Outcome 3 Asthma Control Questionnaire.

Comparison 2 FP versus HFA‐BDP (dose ratio 1:1; crossover trials), Outcome 4 Growth (cm).
Figuras y tablas -
Analysis 2.4

Comparison 2 FP versus HFA‐BDP (dose ratio 1:1; crossover trials), Outcome 4 Growth (cm).

Table 1. Search history

Date

Search detail

All years: <March 2005

Total number of references: 158

Excluded at abstract stage: 126

References identified for additional scrutiny: 34

Unique studies identified: 21

Awaiting assessment: 1

Excluded: 13

Included: 7

March 2005 to January 2006

Total number of references: 22

Excluded at abstract stage: 15

References to studies already included: 1

References retrieved for further scrutiny: 6

Unique studies identified: 5

Awating assessment: 0

Excluded: 4

Included: 1

January 2006 to January 2007

Total number of references: 20

Excluded at abstract stage: 17

References to studies already included: 0

References retrieved for further scrutiny: 3

Unique studies identified: 3

Awating assessment: 0

Excluded: 3

Included: 0

January 2009 to January 2010

Total number of references: 21

Excluded at abstract stage: 21

Figuras y tablas -
Table 1. Search history
Table 2. Approximation of asthma severity

Study ID

IC FEV1 (% predicted)

BL FEV1

BL symptoms

Oral steroids at BL

ICS at BL

Author opinion

Approx severity

Ahrens 2003

Not stated (described as 'abnormal')

Not stated

Not stated

Not stated

Yes ‐ CFC‐BDP 200mcg/d

Not stated

Unclear

Aubier 2001

Not stated

71.7‐8%

Asthma symptoms had to clinically indicate an increase in steroid treatment on previous treatment by 500‐1000mcg/day, with 'as required' ß‐agonist

No

Yes: requiring BDP equivalent 500‐1000 mcg/d

Moderate to severe

Moderate to severe

Currie 2002

>70% predicted

87.9‐89%

Not stated. Treatment with SABA only for previous 3 months

No

Yes

Mild to moderate

Mild to moderate

Fairfax 2001

Not stated

75.7‐78.2%

At least one of: sleep disturbance; daily use of at least 2 puffs SABA; daily score of at least 2 on three days for wheeze, cough, shortness of breath, chest tightness

No

Yes ‐ Equivalent to FP100‐250mcg/d

Moderate

Moderate

Huchon 2003

Not stated

Not stated

Not stated

Not stated

Not stated

Mild to moderate

Unclear

Molimard 2005

No details

76‐9% predicted

Requirement for 2 puffs SABA/day

No

Yes: inadequate control of symptoms at </=500mcg/d FP

Moderate‐severe

Moderate

van Aalderan 2007

Not stated

87% predicted

'...sub‐optimal asthma control requiring the
initiation of, or an increase in current ICS therapy.'

Not stated

Yes (BDP 200mcg day or equivalent)

Mild to moderate

Mild to moderate

Robroeks 2008

Not stated

107%

Not stated

No

Yes ‐ equivalent to 500mcg or less of FP equivalent

Moderate

Mild to Moderate

Thongngam 2005

<80% predicted

57% predicted

Symptomatic despite requirement for medium‐high dose ICS

Yes ‐ course of OCS within three months

Yes ‐ moderate‐high doses of ICS required

Moderate to severe

Moderate to severe

Tunon‐de‐Lara 2007  

>60% predicted

88% predicted

>/=7 puffs of SABA or 2 nocturnal symptoms, or mild limitation of activity linked to asthma symptoms in last 15 days

No

Yes ‐ up to 1000mcg/d

Mild to moderate

Mild to moderate

BL= baseline
IC= inclusion criterion
OCS= oral corticosteroid
ICS= inhaled corticosteroid

Figuras y tablas -
Table 2. Approximation of asthma severity
Comparison 1. FP versus HFA‐BDP (dose ratio 1:1; parallel group trials)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in FEV1 (Litres) Show forest plot

3

659

Mean Difference (IV, Fixed, 95% CI)

0.04 [‐0.03, 0.11]

2 Change in FEV1 % predicted Show forest plot

3

334

Mean Difference (IV, Fixed, 95% CI)

‐2.18 [‐4.62, 0.26]

3 Change in morning PEFR compared to baseline (L/min) Show forest plot

3

393

Mean Difference (IV, Fixed, 95% CI)

‐2.31 [‐12.53, 7.91]

4 Change in PEFR predicted (%) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Beta‐agonist use (puffs/day) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6 Beta‐agonist use (% reduction in days using beta‐agonist) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

7 Change in rescue medication usage (Juniper questionnaire item 6) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

8 Change in asthma‐free days per week Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

9 Change in % days without asthma symptoms Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

10 Change in heath‐related quality of life (AQLQ) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11 Change in health‐related quality of life (ACQ) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

12 Withdrawals (any reason) Show forest plot

6

1011

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.47, 1.14]

13 Dysphonia Show forest plot

2

496

Risk Ratio (M‐H, Fixed, 95% CI)

1.53 [0.92, 2.54]

14 Headache Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15 Increased asthma symptoms Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

16 Oral candidiasis Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

17 Any adverse event Show forest plot

3

668

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.72, 1.08]

18 Admission to hospital for asthma Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 1. FP versus HFA‐BDP (dose ratio 1:1; parallel group trials)
Comparison 2. FP versus HFA‐BDP (dose ratio 1:1; crossover trials)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 FEV1 (predicted) Show forest plot

2

100

% (Fixed, 95% CI)

‐0.09 [‐5.02, 4.84]

2 Morning PEFR Show forest plot

1

Litres/min (Fixed, 95% CI)

Totals not selected

3 Asthma Control Questionnaire Show forest plot

1

Mean Difference (Fixed, 95% CI)

Totals not selected

4 Growth (cm) Show forest plot

1

Mean Difference (Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 2. FP versus HFA‐BDP (dose ratio 1:1; crossover trials)