Table 13Characteristics of head-to-head studies comparing BUD/FM for maintenance and relief (MART) with ICS/LABA for maintenance and Short-Acting Beta-Agonist (SABA) for relief

StudyStudy design
N
Duration
Country
Population
Setting
Comparison (total daily ex-mouthpiece dose in mcg)EquipotentaQuality rating
BUD/FM MART compared with BUD/FM for maintenance and SABA for relief or compared with FP/SM for maintenance and SABA for relief
Bisgaard et al. 2006103bRCT, DB

341

12 months
Multinational (12)

Age 4–11, mild-moderate persistent asthma ≥ 6 months, not controlled on ICS, smoking status NR

Multicenter (41)
BUD/FM MART (80/4.5 + as needed) DPI; overall mean daily dose including rescue use 126/7.1
vs.
BUD/FM (80/4.5) DPI + terbutaline 0.4mg as needed
vs.
BUD (80) DPI + terbutaline 0.4mg as needed
YesFair
Bousquet et al. 2007104RCT

2309

6 months
Multinational (17)

Age ≥ 12, uncontrolled on ICS or ICS+LABA, moderate persistent asthma, excluded smokers with ≥ 10 pack-year history, 4–5% were current smokers

Multicenter (184 centers)
BUD/FM MART (640/18 + as-needed) DPI (overall mean daily BUD dose including rescue use 792)
vs.
FP/SM (1000/100 + terbutaline 0.4mg as needed)
DPI
No (medium BUD vs. high FP)Fair
O’Byrne et al. 2005105

AND

Bisgaard et al. 2006103
RCT

2760

1 year
Multinational (22)

Age 4–80, uncontrolled on ICS, moderate persistent asthma, smoking status NR

Multicenter (246)
Adults:
BUD/FM MART (160/9 + as-needed) DPI; overall mean daily dose approx. 250 – estimated from graph)
vs.
BUD/FM (160/9) DPI + terbutaline 0.4mg as needed)
vs.
BUD (640) DPI med + terbutaline 0.4mg as needed;

Children:
BUD/FM MART (80/4.5 + as needed) DPI; overall mean daily dose including rescue use 126/7.1
vs.
BUD/FM (80/4.5) DPI + terbutaline 0.4mg as needed
vs.
BUD (80) DPI + terbutaline 0.4mg as needed
Yes (for the 2 arms of interest in this comparison)Fair
Kuna et al. 200798

AND

Price et al. 200799

AND

Kuna 2010100
RCT

3335

6 months
Multinational

Age ≥ 12, not controlled, taking ICS at entry (46–47% also taking LABA at entry), 5–7% were current smokers

Multicenter
BUD/FM MART (320/9 + as-needed use) DPI (mean BUD/FM dose including rescue use 483/13.6)
vs.
BUD/FM (640/18) med DPI + terbutaline 0.4mg as needed
vs.
FP/SM (500/100) high pMDI + terbutaline 0.4mg as needed
No (low mean AD dose BUD compared with medium fixed dose BUD compared with high fixed dose FP)Good
Vogelmeier, et al.106RCT

2135

12 months
Multinational (16)

Age ≥ 12, not controlled, taking ICS at entry, smoking status NR

Multicenter (246)
BUD/FM MART (640/18 + as-needed) DPI med (overall mean daily BUD dose including rescue use ~ 650)
vs.
FP/SM (500/100 + as-needed SABA) DPI med + salbutamol as needed DPI or pMDI
YesGood

Abbreviations: BUD = budesonide; BUD/FM budesonide and formoterol administered in a single inhaler; DB = double-blind; DPI = dry powder inhaler; FD= fixed dose; FM = formoterol; FP = fluticasone propionate; FP/SM = fluticasone and salmeterol administered in a single inhaler; ICS = inhaled corticosteroids; LABAs = long-acting beta-2 agonists; MART = maintenance and reliever therapy; OL = open-label; pMDI= pressurized metered dose inhaler; RCT= randomized controlled trial; SABA = short-acting beta agonist; SM = salmeterol

a

Equipotency in BUD/FM + as-needed arms was determined by overall mean daily dose of ICS

b

This publication describes the pediatric subset of the population in the O’Byrne et al. 2005 trial below.105 Thus it is not a separate trial and is not included in meta-analyses, to avoid double counting subjects

Equipotency in BUD/FM + as-needed arms was determined by overall mean daily dose of ICS

This publication describes the pediatric subset of the population in the O’Byrne et al. 2005 trial below.105 Thus it is not a separate trial and is not included in meta-analyses, to avoid double counting subjects

From: Results

Cover of Drug Class Review: Controller Medications for Asthma
Drug Class Review: Controller Medications for Asthma: Final Update 1 Report [Internet].
Jonas DE, Wines RCM, DelMonte M, et al.
Portland (OR): Oregon Health & Science University; 2011 Apr.
Copyright © 2011 by Oregon Health & Science University.

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