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Flow chart to illustrate separation of review between three comparisons. Six RCTs met the original entry criteria of the review. All of these had a placebo and long‐acting beta‐agonist arm, and five assessed combination against steroids. Seven new studies with one or more control comparisons were identified: five had a placebo arm, three had a long‐acting beta‐agonist arm, and two had an inhaled steroid treatment arm.
Figuras y tablas -
Figure 1

Flow chart to illustrate separation of review between three comparisons. Six RCTs met the original entry criteria of the review. All of these had a placebo and long‐acting beta‐agonist arm, and five assessed combination against steroids. Seven new studies with one or more control comparisons were identified: five had a placebo arm, three had a long‐acting beta‐agonist arm, and two had an inhaled steroid treatment arm.

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

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

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Forest plot of exacerbations (data expressed as a pooled ratio of rates).
Figuras y tablas -
Figure 3

Forest plot of exacerbations (data expressed as a pooled ratio of rates).

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Forest plot of mortality pooled across the comparisons of BDF and FPS versus their respective monocomponent LABA preparation.
Figuras y tablas -
Figure 4

Forest plot of mortality pooled across the comparisons of BDF and FPS versus their respective monocomponent LABA preparation.

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Forest plot of pneumonia data.
Figuras y tablas -
Figure 5

Forest plot of pneumonia data.

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Comparison 1 Combined inhalers versus Long‐acting beta‐agonists (Primary Outcomes), Outcome 1 Exacerbations (combined rx versus beta‐agonist).
Figuras y tablas -
Analysis 1.1

Comparison 1 Combined inhalers versus Long‐acting beta‐agonists (Primary Outcomes), Outcome 1 Exacerbations (combined rx versus beta‐agonist).

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Comparison 1 Combined inhalers versus Long‐acting beta‐agonists (Primary Outcomes), Outcome 2 Mortality.
Figuras y tablas -
Analysis 1.2

Comparison 1 Combined inhalers versus Long‐acting beta‐agonists (Primary Outcomes), Outcome 2 Mortality.

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Comparison 1 Combined inhalers versus Long‐acting beta‐agonists (Primary Outcomes), Outcome 3 Pneumonia.
Figuras y tablas -
Analysis 1.3

Comparison 1 Combined inhalers versus Long‐acting beta‐agonists (Primary Outcomes), Outcome 3 Pneumonia.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 1 Number of participants with one or more exacerbation.
Figuras y tablas -
Analysis 2.1

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 1 Number of participants with one or more exacerbation.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 2 End of treatment mean number of exacerbations per participant.
Figuras y tablas -
Analysis 2.2

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 2 End of treatment mean number of exacerbations per participant.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 3 Exacerbations (rate ratio).
Figuras y tablas -
Analysis 2.3

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 3 Exacerbations (rate ratio).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 4 Exacerbations by type.
Figuras y tablas -
Analysis 2.4

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 4 Exacerbations by type.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 5 Mortality.
Figuras y tablas -
Analysis 2.5

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 5 Mortality.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 6 Change from baseline in St George's Respiratory Questionnaire (total score).
Figuras y tablas -
Analysis 2.6

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 6 Change from baseline in St George's Respiratory Questionnaire (total score).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 7 Change from baseline in St George's Respiratory Questionnaire (domain ‐ symptoms).
Figuras y tablas -
Analysis 2.7

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 7 Change from baseline in St George's Respiratory Questionnaire (domain ‐ symptoms).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 8 Change from baseline in St George's Respiratory Questionnaire (domain ‐ activity).
Figuras y tablas -
Analysis 2.8

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 8 Change from baseline in St George's Respiratory Questionnaire (domain ‐ activity).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 9 Change from baseline in St George's Respiratory Questionnaire (domain ‐ impact).
Figuras y tablas -
Analysis 2.9

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 9 Change from baseline in St George's Respiratory Questionnaire (domain ‐ impact).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 10 End of treatment St George's Respiratory Questionnaire scores (total score).
Figuras y tablas -
Analysis 2.10

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 10 End of treatment St George's Respiratory Questionnaire scores (total score).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 11 End of treatment St George's Respiratory Questionnaire scores (domain ‐ symptoms).
Figuras y tablas -
Analysis 2.11

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 11 End of treatment St George's Respiratory Questionnaire scores (domain ‐ symptoms).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 12 Change from baseline in Chronic Respiratory Disease Questionnaire scores.
Figuras y tablas -
Analysis 2.12

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 12 Change from baseline in Chronic Respiratory Disease Questionnaire scores.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 13 End of treatment Transitional dyspnea index (TDI).
Figuras y tablas -
Analysis 2.13

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 13 End of treatment Transitional dyspnea index (TDI).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 14 End of treatment symptom scores.
Figuras y tablas -
Analysis 2.14

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 14 End of treatment symptom scores.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 15 Change from baseline in Transitional Dyspnoea Index (TDI).
Figuras y tablas -
Analysis 2.15

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 15 Change from baseline in Transitional Dyspnoea Index (TDI).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 16 Change in MRC rated dyspnoea.
Figuras y tablas -
Analysis 2.16

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 16 Change in MRC rated dyspnoea.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 17 Change from baseline in predose FEV1.
Figuras y tablas -
Analysis 2.17

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 17 Change from baseline in predose FEV1.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 18 Change from baseline in postdose FEV1.
Figuras y tablas -
Analysis 2.18

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 18 Change from baseline in postdose FEV1.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 19 End of treatment FEV1 (Litres).
Figuras y tablas -
Analysis 2.19

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 19 End of treatment FEV1 (Litres).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 20 FEV1 (% predicted ‐ absolute scores).
Figuras y tablas -
Analysis 2.20

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 20 FEV1 (% predicted ‐ absolute scores).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 21 Change from baseline in am PEF (L/min).
Figuras y tablas -
Analysis 2.21

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 21 Change from baseline in am PEF (L/min).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 22 Change from baseline in rescue medication usage (puffs/day).
Figuras y tablas -
Analysis 2.22

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 22 Change from baseline in rescue medication usage (puffs/day).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 23 End of treatment rescue medication usage (puffs/day).
Figuras y tablas -
Analysis 2.23

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 23 End of treatment rescue medication usage (puffs/day).

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 24 Withdrawals.
Figuras y tablas -
Analysis 2.24

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 24 Withdrawals.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 25 Withdrawals due to lack of efficacy.
Figuras y tablas -
Analysis 2.25

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 25 Withdrawals due to lack of efficacy.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 26 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 2.26

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 26 Withdrawals due to adverse events.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 27 Adverse events ‐ any event.
Figuras y tablas -
Analysis 2.27

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 27 Adverse events ‐ any event.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 28 Adverse events ‐ candidiasis.
Figuras y tablas -
Analysis 2.28

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 28 Adverse events ‐ candidiasis.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 29 Adverse events ‐ pneumonia.
Figuras y tablas -
Analysis 2.29

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 29 Adverse events ‐ pneumonia.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 30 Adverse events ‐ headache.
Figuras y tablas -
Analysis 2.30

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 30 Adverse events ‐ headache.

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Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 31 Adverse events ‐ upper respiratory tract infection.
Figuras y tablas -
Analysis 2.31

Comparison 2 Fluticasone/salmeterol (FPS) versus salmeterol (SAL), Outcome 31 Adverse events ‐ upper respiratory tract infection.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 1 Severe Exacerbations.
Figuras y tablas -
Analysis 4.1

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 1 Severe Exacerbations.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 2 Mean exacerbation rates per patient per year.
Figuras y tablas -
Analysis 4.2

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 2 Mean exacerbation rates per patient per year.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 3 Quality of life ‐ SGRQ (change scores).
Figuras y tablas -
Analysis 4.3

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 3 Quality of life ‐ SGRQ (change scores).

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 4 Quality of life ‐ change scores.
Figuras y tablas -
Analysis 4.4

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 4 Quality of life ‐ change scores.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 6 Symptoms (change scores).
Figuras y tablas -
Analysis 4.6

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 6 Symptoms (change scores).

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 7 Mean FEV1 (% increase from baseline).
Figuras y tablas -
Analysis 4.7

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 7 Mean FEV1 (% increase from baseline).

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 8 Rescue medication usage.
Figuras y tablas -
Analysis 4.8

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 8 Rescue medication usage.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 9 Mortality.
Figuras y tablas -
Analysis 4.9

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 9 Mortality.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 10 Pneumonia.
Figuras y tablas -
Analysis 4.10

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 10 Pneumonia.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 13 Adverse events ‐ 'serious' events.
Figuras y tablas -
Analysis 4.13

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 13 Adverse events ‐ 'serious' events.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 15 Withdrawals due to worsening COPD symptoms.
Figuras y tablas -
Analysis 4.15

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 15 Withdrawals due to worsening COPD symptoms.

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Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 16 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 4.16

Comparison 4 Budesonide/formoterol (BDF) versus formoterol (F), Outcome 16 Withdrawals due to adverse events.

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Table 1. Search history

Version

Detail

1st published version ‐ Issue 4, 2003 (All years to April 2002)

References identified: 34
References retrieved: 7
Studies excluded 3 (Cazzola 2000; Chapman 2002; Soriano 2002)
Studies identified from supplementary searching: 4 (Dal Negro 2003; Hanania 2003 ‐ both included; Cazzola 2002a; Cazzola 2004 ‐ both excluded).
Studies included: 4

2nd published version ‐ Issue 3, 2004 (April 2003‐April 2004)

References identified: 12
References retrieved: 3 (2 papers full publication of a previously included or cited studies study (Dal Negro 2003; Hanania 2003). Hand searching identified two further references to the COSMIC 2003 study.
Studies identified from supplementary searching: 1 (TRISTAN 2003)
New studies included: 2
Total studies included: 6

3rd published version ‐ Issue 3, 2005 (April 2004‐April 2005)

References identified: 52
References retrieved: 46 (references to studies already included/excluded/ongoing: 24)
New unique studies identified: 10 (ongoing studies: 2)
New studies included: 0
Total studies included: 6

4th published version ‐ April 2005 ‐ April 2007

References identified: 66
References retrieved: 27 (references to studies already included/excluded/ongoing: )
New unique studies identified: 8 (ongoing studies: 0)
New studies included: 7
Total studies included: 13

Figuras y tablas -
Table 1. Search history
Ir a la tabla de la revisión
Table 2. Rates and NNT of pneumonia

Study ID

Study duration

Rate on LABA alone %

NNT

O'Donnell 2006

8 weeks

0

NA

Hanania 2003

24 weeks

0.6

291 (192 to 525)

Mahler 2002

24 weeks

0

NA

SCO100470

24 weeks

0.8

219 (145 to 395)

Kardos 2007

48 weeks

1.4

126 (84 to 228)

TRISTAN

52 weeks

2.4

75 (50 to 135)

TORCH

156 weeks

13.3

17 (12 to 29)

Calverley 2003

52 weeks

2.7

67 (45 to 120)
Figuras y tablas -
Table 2. Rates and NNT of pneumonia
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Comparison 1. Combined inhalers versus Long‐acting beta‐agonists (Primary Outcomes)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Exacerbations (combined rx versus beta‐agonist) Show forest plot

5

Rate ratio (Fixed, 95% CI)

0.82 [0.78, 0.88]

1.1 Fluticasone/salmeterol

3

Rate ratio (Fixed, 95% CI)

0.84 [0.78, 0.89]

1.2 Budesonide/formoterol

2

Rate ratio (Fixed, 95% CI)

0.76 [0.64, 0.90]

2 Mortality Show forest plot

6

6747

Odds Ratio (M‐H, Fixed, 95% CI)

0.89 [0.73, 1.08]

2.1 Fluticasone/salmeterol

4

5829

Odds Ratio (M‐H, Fixed, 95% CI)

0.92 [0.75, 1.13]

2.2 Budesonide/formoterol

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

0.56 [0.26, 1.19]

3 Pneumonia Show forest plot

8

7172

Odds Ratio (M‐H, Fixed, 95% CI)

1.58 [1.32, 1.88]

3.1 Fluticasone/salmeterol

7

6663

Odds Ratio (M‐H, Fixed, 95% CI)

1.59 [1.33, 1.91]

3.2 Budesonide/formoterol

1

509

Odds Ratio (M‐H, Fixed, 95% CI)

1.15 [0.41, 3.23]
Figuras y tablas -
Comparison 1. Combined inhalers versus Long‐acting beta‐agonists (Primary Outcomes)
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Comparison 2. Fluticasone/salmeterol (FPS) versus salmeterol (SAL)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with one or more exacerbation Show forest plot

4

1803

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.69, 1.05]

1.1 Reversible population

1

121

Odds Ratio (M‐H, Fixed, 95% CI)

1.93 [0.17, 21.90]

1.2 Partially reversible population (mixed population)

2

688

Odds Ratio (M‐H, Fixed, 95% CI)

1.22 [0.83, 1.78]

1.3 Poorly reversible population

1

994

Odds Ratio (M‐H, Fixed, 95% CI)

0.72 [0.56, 0.93]

1.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 End of treatment mean number of exacerbations per participant Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Exacerbations (rate ratio) Show forest plot

3

Rate ratio (Fixed, 95% CI)

0.84 [0.78, 0.89]

3.1 Partially reversible population

0

Rate ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Poorly reversible population

3

Rate ratio (Fixed, 95% CI)

0.84 [0.78, 0.89]

3.3 Unclear reversibility

0

Rate ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Exacerbations by type Show forest plot

3

Rate ratio (Random, 95% CI)

Subtotals only

4.1 Requirement for oral steroids

2

Rate ratio (Random, 95% CI)

0.77 [0.64, 0.93]

4.2 Requirement for antibiotic treatment

0

Rate ratio (Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Requirement for oral steroid or antibiotic treatment

0

Rate ratio (Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Hospitalisation

2

Rate ratio (Random, 95% CI)

0.86 [0.56, 1.31]

5 Mortality Show forest plot

4

5829

Odds Ratio (M‐H, Fixed, 95% CI)

0.92 [0.75, 1.13]

5.1 Mortality: three year data

1

3054

Odds Ratio (M‐H, Fixed, 95% CI)

0.92 [0.75, 1.14]

5.2 Mortality: >one and <three year data

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 Mortality: one year data

3

2775

Odds Ratio (M‐H, Fixed, 95% CI)

0.83 [0.38, 1.81]

5.4 Mortality: 6 month data

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Change from baseline in St George's Respiratory Questionnaire (total score) Show forest plot

4

SGRQ units (Fixed, 95% CI)

‐1.64 [‐2.28, 1.00]

6.1 Partially reversible population

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Poorly reversible population

4

SGRQ units (Fixed, 95% CI)

‐1.64 [‐2.28, 1.00]

6.3 Unclear reversibility

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Change from baseline in St George's Respiratory Questionnaire (domain ‐ symptoms) Show forest plot

2

SGRQ units (Fixed, 95% CI)

‐2.65 [‐3.98, ‐1.31]

7.1 Partially reversible population

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 Poorly reversible population

2

SGRQ units (Fixed, 95% CI)

‐2.65 [‐3.98, ‐1.31]

7.3 Unclear reversibility

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Change from baseline in St George's Respiratory Questionnaire (domain ‐ activity) Show forest plot

2

SGRQ units (Fixed, 95% CI)

‐1.87 [‐3.17, ‐0.58]

8.1 Partially reversible population

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 Poorly reversible population

2

SGRQ units (Fixed, 95% CI)

‐1.87 [‐3.17, ‐0.58]

8.3 Unclear reversibility

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

9 Change from baseline in St George's Respiratory Questionnaire (domain ‐ impact) Show forest plot

2

SGRQ units (Fixed, 95% CI)

‐1.05 [‐2.25, 0.14]

9.1 Partially reversible population

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 Poorly reversible population

2

SGRQ units (Fixed, 95% CI)

‐1.05 [‐2.25, 0.14]

9.3 Unclear reversibility

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

10 End of treatment St George's Respiratory Questionnaire scores (total score) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

10.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11 End of treatment St George's Respiratory Questionnaire scores (domain ‐ symptoms) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 Change from baseline in Chronic Respiratory Disease Questionnaire scores Show forest plot

2

680

Mean Difference (IV, Fixed, 95% CI)

2.83 [0.25, 5.41]

12.1 Partially reversible population (mixed population)

2

680

Mean Difference (IV, Fixed, 95% CI)

2.83 [0.25, 5.41]

12.2 Poorly reversible population

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 End of treatment Transitional dyspnea index (TDI) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

13.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14 End of treatment symptom scores Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

14.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

15 Change from baseline in Transitional Dyspnoea Index (TDI) Show forest plot

2

677

Mean Difference (IV, Random, 95% CI)

0.61 [‐0.47, 1.68]

15.1 Partially reversible population (mixed population)

2

677

Mean Difference (IV, Random, 95% CI)

0.61 [‐0.47, 1.68]

15.2 Poorly reversible population

0

0

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 Change in MRC rated dyspnoea Show forest plot

1

symptoms (Fixed, 95% CI)

Totals not selected

16.1 Partially reversible population

0

symptoms (Fixed, 95% CI)

0.0 [0.0, 0.0]

16.2 Poorly reversible population

0

symptoms (Fixed, 95% CI)

0.0 [0.0, 0.0]

16.3 Unclear reversibility

1

symptoms (Fixed, 95% CI)

0.0 [0.0, 0.0]

17 Change from baseline in predose FEV1 Show forest plot

3

Litres (Fixed, 95% CI)

0.06 [0.03, 0.10]

17.1 Reversible population

3

Litres (Fixed, 95% CI)

0.07 [0.02, 0.12]

17.2 Partially reversible population (mixed population)

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

17.3 Poorly reversible population

2

Litres (Fixed, 95% CI)

0.06 [0.01, 0.10]

17.4 Unclear reversibility

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

18 Change from baseline in postdose FEV1 Show forest plot

3

Litres (Fixed, 95% CI)

0.05 [0.03, 0.06]

18.1 Reversible population

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

18.2 Partially reversible population (mixed population)

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

18.3 Poorly reversible population

3

Litres (Fixed, 95% CI)

0.05 [0.03, 0.06]

18.4 Unclear reversibility

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

19 End of treatment FEV1 (Litres) Show forest plot

2

1780

Mean Difference (IV, Fixed, 95% CI)

0.01 [‐0.02, 0.03]

19.1 Partially reversible population (mixed population)

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

19.2 Poorly reversible population

2

1780

Mean Difference (IV, Fixed, 95% CI)

0.01 [‐0.02, 0.03]

20 FEV1 (% predicted ‐ absolute scores) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

20.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

20.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

21 Change from baseline in am PEF (L/min) Show forest plot

2

L/min (Fixed, 95% CI)

11.61 [7.91, 15.30]

21.1 Partially reversible population

0

L/min (Fixed, 95% CI)

0.0 [0.0, 0.0]

21.2 Poorly reversible population

2

L/min (Fixed, 95% CI)

11.61 [7.91, 15.30]

21.3 Unclear reversibility

0

L/min (Fixed, 95% CI)

0.0 [0.0, 0.0]

22 Change from baseline in rescue medication usage (puffs/day) Show forest plot

2

673

Mean Difference (IV, Fixed, 95% CI)

‐0.30 [‐0.94, 0.34]

22.1 Partially reversible population (mixed population)

2

673

Mean Difference (IV, Fixed, 95% CI)

‐0.30 [‐0.94, 0.34]

22.2 Poorly reversible population

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

23 End of treatment rescue medication usage (puffs/day) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

23.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

23.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

24 Withdrawals Show forest plot

7

6647

Odds Ratio (M‐H, Fixed, 95% CI)

0.89 [0.80, 1.00]

24.1 Reversible population

1

121

Odds Ratio (M‐H, Fixed, 95% CI)

2.95 [0.30, 29.18]

24.2 Partially reversible population (mixed population)

2

680

Odds Ratio (M‐H, Fixed, 95% CI)

1.03 [0.74, 1.43]

24.3 Poorly reversible population

4

5846

Odds Ratio (M‐H, Fixed, 95% CI)

0.87 [0.78, 0.98]

24.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

25 Withdrawals due to lack of efficacy Show forest plot

4

5160

Odds Ratio (M‐H, Fixed, 95% CI)

0.49 [0.33, 0.72]

25.1 Reversible population

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

25.2 Partially reversible population (mixed population)

1

325

Odds Ratio (M‐H, Fixed, 95% CI)

0.40 [0.10, 1.59]

25.3 Poorly reversible population

3

4835

Odds Ratio (M‐H, Fixed, 95% CI)

0.50 [0.33, 0.74]

25.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26 Withdrawals due to adverse events Show forest plot

6

6316

Odds Ratio (M‐H, Fixed, 95% CI)

0.90 [0.78, 1.04]

26.1 Reversible population

1

121

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

26.2 Partially reversible population (mixed population)

1

333

Odds Ratio (M‐H, Fixed, 95% CI)

0.97 [0.41, 2.30]

26.3 Poorly reversible population

4

5862

Odds Ratio (M‐H, Fixed, 95% CI)

0.90 [0.78, 1.04]

26.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

27 Adverse events ‐ any event Show forest plot

7

6671

Odds Ratio (M‐H, Fixed, 95% CI)

1.02 [0.91, 1.15]

27.1 Reversible population

1

121

Odds Ratio (M‐H, Fixed, 95% CI)

0.80 [0.39, 1.64]

27.2 Partially reversible population (mixed population)

2

688

Odds Ratio (M‐H, Fixed, 95% CI)

1.28 [0.92, 1.79]

27.3 Poorly reversible population

4

5862

Odds Ratio (M‐H, Fixed, 95% CI)

0.99 [0.87, 1.13]

27.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

28 Adverse events ‐ candidiasis Show forest plot

4

1539

Odds Ratio (M‐H, Fixed, 95% CI)

4.28 [2.38, 7.69]

28.1 Reversible population

1

121

Odds Ratio (M‐H, Fixed, 95% CI)

2.90 [0.12, 72.67]

28.2 Partially reversible population (mixed population)

2

688

Odds Ratio (M‐H, Fixed, 95% CI)

5.15 [2.10, 12.62]

28.3 Poorly reversible population

1

730

Odds Ratio (M‐H, Fixed, 95% CI)

3.71 [1.66, 8.28]

28.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

29 Adverse events ‐ pneumonia Show forest plot

7

6663

Odds Ratio (M‐H, Fixed, 95% CI)

1.59 [1.33, 1.91]

29.1 Reversible population

1

121

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

29.2 Partially reversible population (mixed population)

2

680

Odds Ratio (M‐H, Fixed, 95% CI)

1.47 [0.24, 8.89]

29.3 Poorly reversible population

4

5862

Odds Ratio (M‐H, Fixed, 95% CI)

1.59 [1.33, 1.91]

29.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

30 Adverse events ‐ headache Show forest plot

6

5658

Odds Ratio (M‐H, Fixed, 95% CI)

1.10 [0.90, 1.36]

30.1 Reversible population

1

121

Odds Ratio (M‐H, Fixed, 95% CI)

0.46 [0.08, 2.60]

30.2 Partially reversible population (mixed population)

2

680

Odds Ratio (M‐H, Fixed, 95% CI)

1.25 [0.82, 1.91]

30.3 Poorly reversible population

3

4857

Odds Ratio (M‐H, Fixed, 95% CI)

1.08 [0.85, 1.37]

30.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

31 Adverse events ‐ upper respiratory tract infection Show forest plot

5

4619

Odds Ratio (M‐H, Fixed, 95% CI)

1.35 [1.13, 1.62]

31.1 Reversible population

1

121

Odds Ratio (M‐H, Fixed, 95% CI)

0.31 [0.01, 7.81]

31.2 Partially reversible population (mixed population)

2

680

Odds Ratio (M‐H, Fixed, 95% CI)

1.43 [0.90, 2.25]

31.3 Poorly reversible population

2

3818

Odds Ratio (M‐H, Fixed, 95% CI)

1.34 [1.10, 1.64]

31.4 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 2. Fluticasone/salmeterol (FPS) versus salmeterol (SAL)
Ir a la tabla de la revisión
Comparison 4. Budesonide/formoterol (BDF) versus formoterol (F)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe Exacerbations Show forest plot

2

Rate ratio (Fixed, 95% CI)

0.78 [0.68, 0.90]

1.1 Partially reversible

0

Rate ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Poorly reversible

2

Rate ratio (Fixed, 95% CI)

0.78 [0.68, 0.90]

2 Mean exacerbation rates per patient per year Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Poorly reversible population

2

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Quality of life ‐ SGRQ (change scores) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Quality of life ‐ change scores Show forest plot

1

SGRQ (Fixed, 95% CI)

Totals not selected

4.1 Partially reversible (mixed population)

0

SGRQ (Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Poorly reversible

1

SGRQ (Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Symptoms ‐ breathlessness (absolute scores)

0

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5.1 Partially reversible population (mixed population)

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 Poorly reversible population

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Symptoms (change scores) Show forest plot

2

Symptom scale (Fixed, 95% CI)

‐0.15 [‐0.37, 0.08]

6.1 Partially reversible (mixed population)

0

Symptom scale (Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Poorly reversible

2

Symptom scale (Fixed, 95% CI)

‐0.15 [‐0.37, 0.08]

7 Mean FEV1 (% increase from baseline) Show forest plot

2

% increase (Random, 95% CI)

3.06 [‐0.86, 6.97]

7.1 Partially reversible

0

% increase (Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Poorly reversible

2

% increase (Random, 95% CI)

3.06 [‐0.86, 6.97]

8 Rescue medication usage Show forest plot

1

Puffs per day (Fixed, 95% CI)

Totals not selected

8.1 Partially reversible (mixed population)

0

Puffs per day (Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 Poorly reversible

1

Puffs per day (Fixed, 95% CI)

0.0 [0.0, 0.0]

9 Mortality Show forest plot

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

0.56 [0.26, 1.19]

9.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 Poorly reversible population

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

0.56 [0.26, 1.19]

10 Pneumonia Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10.1 Partially reversible population (mixed population)

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 Poorly reversible population

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 Adverse events ‐ 'serious' events Show forest plot

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

0.84 [0.62, 1.13]

13.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

13.2 Poorly reversible population

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

0.84 [0.62, 1.13]

14 Adverse events ‐ candidiasis

0

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

14.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

14.2 Poorly reversible population

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15 Withdrawals due to worsening COPD symptoms Show forest plot

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

0.49 [0.33, 0.71]

15.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.2 Poorly reversible population

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

0.49 [0.33, 0.71]

16 Withdrawals due to adverse events Show forest plot

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

1.12 [0.68, 1.84]

16.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.2 Poorly reversible population

2

918

Odds Ratio (M‐H, Fixed, 95% CI)

1.12 [0.68, 1.84]
Figuras y tablas -
Comparison 4. Budesonide/formoterol (BDF) versus formoterol (F)
Ir a la tabla de la revisión