Fluticasone versus HFA‐beclomethasone dipropionate for chronic asthma in adults and children

Toby J Lasserson; Christopher J Cates; Ann‐Britt Jones; Emma H Steele; John White

doi:10.1002/14651858.CD005309.pub2

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Analysis 1.1

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

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Analysis 1.2

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 2 Change in morning PEFR compared to baseline (L/min).

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Analysis 1.3

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 3 Beta‐agonist use (puffs/day).

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Analysis 1.4

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 4 Beta‐agonist use (% reduction in days using beta‐agonist).

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Analysis 1.5

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 5 Change in rescue medication usage (Juniper questionnaire item 6).

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Analysis 1.6

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 6 Change in asthma‐free days per week.

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Analysis 1.7

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 7 Change in % days without asthma symptoms.

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Analysis 1.8

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 8 Change in heath‐related quality of life (AQLQ).

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Analysis 1.9

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 9 Change in health‐related quality of life (ACQ).

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Analysis 1.10

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 10 Withdrawals (any reason).

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Analysis 1.11

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 11 Dysphonia.

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Analysis 1.12

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

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Analysis 1.13

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

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Analysis 1.14

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

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Analysis 1.15

Comparison 1 FP versus HFA‐BDP (dose ratio 1:1; parallel group trials), Outcome 15 Any adverse event.

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Analysis 2.1

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

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Analysis 2.2

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

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Table 1. Search history

Date	Search detail
All years: <March 05	Total number of references: 158 Excluded at abstract stage: 126 References identified for additional scrutiny: 34 Unique studies identified: 21 Awaiting assessment: 2 Excluded: 12 Included: 7

Table 1. Search history

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Table 2. Approximation of asthma severity

Study ID	IC FEV1 (% pred)	BL FEV1	BL symptoms	Oral steroids at BL	ICS at BL	Author opinion	Approx severity
BL= baseline IC= inclusion criterion OCS= oral corticosteroid ICS= inhaled corticosteroid
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
Price 2003	Not stated	Not stated	Not stated	Not stated	Not stated	Not stated	Unclear

Table 2. Approximation of asthma severity

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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 morning PEFR compared to baseline (L/min) Show forest plot	2	364	Mean Difference (IV, Fixed, 95% CI)	‐0.69 [‐11.21, 9.83]

3 Beta‐agonist use (puffs/day) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Beta‐agonist use (% reduction in days using beta‐agonist) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5 Change in rescue medication usage (Juniper questionnaire item 6) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6 Change in asthma‐free days per week Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

7 Change in % days without asthma symptoms Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

8 Change in heath‐related quality of life (AQLQ) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

9 Change in health‐related quality of life (ACQ) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

10 Withdrawals (any reason) Show forest plot	3	668	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.40, 1.24]

11 Dysphonia Show forest plot	2	496	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [0.92, 2.54]

12 Headache Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

13 Increased asthma symptoms Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

14 Oral candidiasis Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

15 Any adverse event Show forest plot	3	668	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.72, 1.08]

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

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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	1		% (Fixed, 95% CI)	Totals not selected

2 Morning PEFR Show forest plot	1		Litres/min (Fixed, 95% CI)	Totals not selected

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

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