Background
Methods
Inclusion criteria, information source, search and study selection
Data extraction and data items
Assessment of risk of bias
Planned analysis and statistical methods
Results
Reference | Study design and treatment duration | Study population | Treatment group | Comparison group | Efficacy outcome measures (as change from baseline at end of treatment unless otherwise indicated) | Significant results between groups (treatment versus comparison) |
---|---|---|---|---|---|---|
Fluticasone propionate (FP) versus beclometasone dipropionate (BDP) | ||||||
Aubier, 200111
| Open-label, parallel-group 8 weeks | Adults (18–75 years) with ≥4-week clinical history of moderate to severe asthma from 31 medical centers | BDP 800 μg/day via HFA-pMDI (n = 101 ITT) High dose | FP 1000 μg via HFA-pMDI (n = 97 ITT) High dose | AM PEF (L/min), PM PEF (L/min), FEV1 (L), patients free from daily asthma symptoms (%), patients using SABA rescue medication (%) | Equivalence demonstrated for AM PEF: CI within ±25 L/min |
Currie, 200212
| Single-blind, crossover 3 weeks per Tx period | Patients (mean [SE] age = 38 [4] years) with mild to moderate asthma | FP 500 μg/d via HFA-pMDI (n = 20 ITT) Medium dose | BDP 500 μg/d via HFA-pMDI (n = 20 ITT) Medium dose | Methacholine PD20, (μg), exhaled tidal NO (ppb), FEV1 (% predicted), AM PEF (L/min) | None |
FP 1000 μg/d via HFA-pMDI (n = 20 ITT) High dose | BDP 1000 μg/d via HFA-pMDI (n = 20 ITT) High dose | Methacholine PD20, (μg), exhaled tidal NO (ppb), FEV1 (% predicted), AM PEF (L/min) | None | |||
Fairfax, 200113
| Double-blind, double-dummy, parallel-group 6 weeks | Patients 18–65 years with at least a 4-week past history of clinically diagnosed asthma from 30 general practice sites | BDP 400 μg/d via HFA-pMDI (n = 88 ITT) Medium dose | FP 400 μg/d via CFC-pMDI (84 ITT) Medium dose | PEFR (L/min), FEV1 (L) | Equivalence demonstrated for AM PEFR: CI within ±25 L/min |
Ohbayashi, 200814
| Double-crossover (results presented from parallel-group analysis of first stage of study) 3 months per Tx | Patients (FP group mean age (years): 61.0 ± 17.4; BDP group mean age: 67.9 ± 13.1) with mild to moderate persistent asthma controlled with FP Diskus for ≤6 months | FP dose dependent on patient, via Diskus (n = 25) | BDP Same dose as FP, via HFA-pMDI (n = 24) | VC, FVC, FEV1, MEFR, PEF (all % predicted), FEF50% (L/s), FEF75% (L/s) | None |
Robroeks, 200815
| Crossover 3 months per Tx | Children (6–12 years) with moderate persistent asthma from outpatient clinic | BDP 200 μg/d via HFA-pMDI (n = 30) Low dose | FP 200 μg/d via DPI (n = 30) Low dose | Absolute measures at end of treatment: FEV1, FVC, MEF50 (all % predicted), FEV1/VC (%) | None |
Thongngarm, 200516
| Open-label 3 months | Patients (≥18 years) with 6-month history of asthma | BDP 320 μg/d via HFA-pMDI (n = 20 ITT) Medium dose | FP 330 μg/d via CFC-pMDI (n = 10 ITT) Medium dose | FEV1, FVC, FEF25–75% (all % predicted), CV (L), CV-VC, post-bronchodilator TLC, TGV, RV, FEV1, FVC, FEF25–75% (all % predicted), AM PEF, night-time awakening, shortness of breath, chest tightness, wheezing, cough, phlegm (all symptoms/day), albuterol use (puffs/day) | BDP users had larger improvement in FEF25–75%
(% predicted), CV, CV-VC, phlegm and albuterol use |
Tunon-de-Lara, 200717
| Open, parallel-group 84 days | Patients with mild or moderate asthma | BDP 400 μg/d via HFA-pMDI (n = 11 PP) Medium dose | FP 500 μg/d via Diskus (n = 14 PP) Medium dose | FEV1, FVC, SVC, SVC-FVC, FEV1/FVC, FEV1/LCV, FEF50% and FEF25–75% (all % predicted) | None |
Van Aalderen, 200718
| Double-blind, double-dummy, parallel-group 6 weeks | Patients (5–12 years) with asthma dx ≥ 3 months from 6 sites | BDP 200 μg/d via HFA-pMDI (n = 139 ITT) Low dose | FP 200 μg/d via CFC-pMDI (n = 140 ITT) Low dose | AM PEF, PM PEF, FEV1, FVC, FEF25–75% (all % predicted), symptom-free days (%), nights without sleep disturbance (%), β2-agonist therapy,mean (puffs/day) | Noninferior: lower CL > −5 (% predicted) for AM PEF; FP users had greater improvement in FEF25–75% (% predicted) |
Fluticasone propionate versus extra-fine ciclesonide (CIC) | ||||||
Bateman, 200819
| Open-label, parallel-group 24 weeks | Outpatient adults and adolescents (12–75 years) with asthma in Europe | CIC 640 μg/d via HFA-pMDI (n = 255 ITT) High dose | FP 660 μg/d via HFA-pMDI (n = 273 ITT) High dose | FEV1 (mL), FVC (L), PEF (L/min), AM PEF (L/min), asthma symptom score, rescue medication use (puffs/day) Absolute measures at end of treatment: Asthma symptom-free days, rescue medication-free days, asthma symptom and rescue medication-free days | Noninferior: lower CL above −200 mL for FEV1; Noninferior: lower CL above −0.2 L for FVC; Noninferior: lower CL above -25 L/min for PEF and AM PEF |
Boulet, 200720
| Open-label, parallel-group 12 weeks | Adult and adolescent (12–75 years) patients with asthma from 59 Tx centers | CIC 320 μg/d via MDI (n = 233 ITT) Medium dose | FP 400 μg/d via DPI (n = 239 ITT) Medium dose | FEV1 (mL), FEV1 (% predicted), FVC (L), SVC (L), AM PEF (L/min), PM PEF (L/min), daytime asthma symptom score, total asthma symptom score, rescue medication use (puffs/day) | Noninferior: lower CL above −200 mL for FEV1; Noninferior: lower CL above −0.2 L for FVC; Noninferior: lower CL above −25 L/min for AM PEF and PM PEF |
Buhl, 200621
| Multicenter, double-blind, double-dummy, parallel-group 12 weeks | Adult and adolescent (12–75 years) patients with asthma from 57 Tx centers | CIC 160 μg/d (n = 266 ITT) Low dose | FP 176 μg/d via HFA-pMDI (n = 263 ITT) Low dose | FEV1 (L), FVC (L), AM PEF (L/min), daytime symptom score, night-time symptom score, total asthma symptom score (day + night score), rescue medication use (puffs/day) | Noninferior: lower CL above -0.2 L for FEV1 and FVC; Noninferior: lower CL above -25 L/min for AM PEF |
Cohen, 20114
| Double-blind, double-dummy, parallel-group 65 days | Adult patients with asthma (18–60 years) recruited from outpatient clinics of pulmonology departments in the Netherlands | CIC 160 μg/d via HFA-pMDI (n = 19) Low dose | FP 200 μg/d via HFA-pMDI (n = 18) Low dose | FEV1 (% predicted), FVC (L), SVC (L), FVC/SVC (L), FEF50% (L/s), FEF25–75% (% predicted) | FP users had greater improvement in FEV1 and FEF25–75% (% predicted) |
Dahl, 201022
| Double-blind, double-dummy, 2-arm, parallel-group 24 weeks | Adult and adolescent patients (12–75 years) with mild to moderate asthma from 48 centers internationally | CIC 80 μg/d via HFA-pMDI (n = 240 ITT) Low dose | FP 200 μg/d via HFA-pMDI (n = 240 ITT) Low dose | FEV1 (L), FVC (L), AM PEF (L/min) Absolute measures at end of treatment: Days with asthma control (%), asthma exacerbations requiring Tx (%) | Noninferior: lower CL above -0.2 L for FEV1 and FVC; Noninferior: lower CL above -25 L/min for AM PEF |
Lee, 200423
| Double-blind, double-dummy, crossover 4 weeks per Tx | Non-smoking patients with mild-to-moderate persistent asthma | CIC 400 μg/d via HFA-pMDI (n = 19) High dose | FP 500 μg/d via HFA-pMDI (n = 19) Medium dose | NO (ppb), FEV1 (L), FEV1 (% predicted), FEF25–75% (L/s), FEF25–75% (% predicted), methacholine PD20 (mg/ml), AM PEF (L/min), PM PEF (L/min), NO (ppb), AM and PM asthma symptom score, AM and PM rescue medication use (puffs/day) | None |
Lee, 200524
| Double-blind, double-dummy, crossover 4 weeks per Tx | Adult patients (mean age 47 years) with moderate, persistent asthma stable for 3 months | CIC 1600 μg/d via HFA-pMDI (n = 14) High dose | FP 2000 μg/d via HFA-pMDI (n = 14) High dose | Absolute measures at end of treatment: FEV1 (L), FEV1 (% predicted), FEF25–75% (L/s), FEF25–75% (% predicted), AM PEF (L/min), PM PEF (L/min), AM and PM asthma symptom score, AM and PM rescue meds (puffs/d), exhaled nitric oxide (ppb), methacholine PC20 (mg/mL) | None |
Magnussen, 200725
| Double-blind, double-dummy, 3-arm, parallel-group 12 weeks | Patients at least 12 years of age with asthma from 91 sites | CIC 80 μg/d via HFA-pMDI (n = 278 ITT) Low dose | FP 178 μg/d via HFA-pMDI (n = 259 ITT) Low dose | FEV1 (mL), FVC (L), PEF (L/min), asthma symptom score, daytime and night-time symptom score, rescue medication use (puffs/day) | Noninferior: lower CL above -200 mL for FEV1; Noninferior: limit NR for FVC and PEF |
CIC 160 μg/d via HFA-pMDI (n = 270 ITT) Low dose | FP 178 μg/d via HFA-pMDI (n = 259 ITT) Low dose | FEV1 (mL), FVC (L), PEF (L/min), asthma symptom score, daytime and night-time symptom score, rescue medication use (puffs/day) | Noninferior: lower CL above -200 mL for FEV1; Noninferior: limit NR for FVC and PEF | |||
Pedersen, 200626
| Multicenter, double-blind, double-dummy, 2-arm, parallel-group 12 weeks | Children (6–15 years) with asthma from 51 sites | CIC 160 μg/d via HFA-pMDI (n = 254 ITT) Low dose | FP 178 μg/d via HFA-pMDI (n = 257 ITT) Low dose | FEV1 (L), PEF (L/min), AM PEF (L/min), PM PEF (L/min), asthma symptom score sum, asthma symptom free days, rescue medication-free days | Noninferior: lower CL greater than −0.1 L for FEV1; Not noninferior: lower CL less than −12.5 L/min for PEF, AM PEF and PM PEF |
Pedersen, 200927
| Double-blind, double-dummy, 3-arm, parallel-group 12 weeks | Children (6–11 years) with asthma from 50 international centers | CIC 80 μg/d via HFA-pMDI (n = 234 ITT) Low dose | FP 178 μg/d via HFA-pMDI (n = 245 ITT) Low dose | FEV1 (L), AM PEF (L/min), asthma symptom score sum, rescue medication use Absolute measures at end of treatment: Asthma exacerbations (%) | Noninferior: lower CL greater than −0.1 L for FEV1; Not noninferior: lower CL less than −12.5 L/min for AM PEF; Noninferior: upper CL less than 0.30 for asthma symptom score sum |
CIC 160 μg/d via HFA-pMDI (n = 232 ITT) Low dose | FP 178 μg/d via HFA-pMDI (n = 245 ITT) Low dose | Noninferior: lower CL greater than −0.1 L for FEV1; Noninferior: lower CL greater than −12.5 L/min for AM PEF; Noninferior: upper CL less than 0.30 for asthma symptom score sum | ||||
Van der Molen, 201028
| Multicenter, parallel-group (series of 3 studies) 12–24 weeks | Health patients with asthma? aged 12–75 years | CIC 320 μg/d via pMDI (n = 224 ITT) Medium dose | FP 400 μg/d via DPI (n = 228 ITT) Medium dose | No efficacy outcomes; only safety outcomes available | |
CIC 640 μg/d via pMDI (n = 244 ITT) High dose | FP 750 μg/d via pMDI (n = 254 ITT) High dose | |||||
CIC 640 μg/d via pMDI (n = 250 ITT) High dose | FP 1000 μg/d via pMDI (n = 237 ITT) High dose | |||||
Fluticasone propionate/salmeterol versus extra-fine beclometasone dipropionate | ||||||
Fowler, 200229
| Double-blind, double-dummy, parallel-group 8 weeks | Patients with asthma aged 16–70 years | BDP 400 μg/d via HFA-pMDI (n = 20) Medium dose | FP/SAL 200/100 μg/d via DPI (n = 19) Low dose | Absolute measures at end of treatment: Methacholine PD20 (μg), FEV1 (L), FEV1 (% predicted), FEF25–75% (L/s), FEF25–75% (% predicted), AM PEF (L/min), PM PEF (L/min), tidal exhaled NO (ppb), symptom score, reliever use (puffs/d) | FP/SAL users had higher post-study methacholine PD20, FEV1 (L), FEV1 (% predicted), post-study AM/PM PEF |
Fluticasone propionate/salmeterol versus extra-fine beclometasone dipropionate/formoterol fumarate | ||||||
Papi, 200730
| Double-blind, 2-arm parallel-group 12 weeks | Patients with asthma aged 18–65 years from 12 outpatient respiratory clinics in Europe | BDP-F 400/24 μg/d via pMDI (n = 115 ITT) Medium dose | FP/SAL 500/100 μg/d via pMDI (n = 113 ITT) Medium dose | AM pre-dose PEF, AM PEF and PM PEF (all L/min), FEV1 (L), FVC (L), Absolute measures at end of treatment: Daytime and night-time symptom score, symptom-free days (%), day time use of rescue medication (puffs) | Noninferior: lower CL above -20 L/min for AM pre-dose PEF; BDP-F users had greater improvement in FVC |
Papi, 201231
| Prospective, controlled, 2-arm parallel-group 24 weeks | Patients with asthma aged 18–65 years from 67 respiratory clinics in Europe | BDP-F 400/24 μg/d via pMDI (n = 206 ITT) Medium dose | FP/SAL 500/100 μg/d via Diskus DPI (n = 216 ITT) Medium dose | Absolute measures at end of treatment: AM PEF (L/min), FEV1 (L), FEV1 (% predicted), PEF (L/min), PEF (% predicted), daytime and night-time symptom score, symptom-free days (%), patients with controlled asthma, asthma exacerbations and severe asthma exacerbations (all %) | Equivalent: CI falls within − 20 to +20 L/min for AM PEF |
Scichilone, 201032
| Double-blind, double-dummy, parallel-group 12 weeks | Adult patients with asthma (18–50 years) in Italy | BDP-F 400/24 μg/d via HFA-pMDI (n = 15) Medium dose | FCS 500/100 μg/d via pMDI (n = 15) Medium dose | Absolute measures at end of treatment: Pre-dose FEV1 (L), FEF25–75% (L/s), PD20 FEV1 methacholine (μg) | None |