Table 33Description of trials included in the Cochrane reviews of mast cell stabilizers

Author Year
Number of trials included
Country
Dates published (range)
Publication status # of trials Children [C], Adults [A]
Funding
Trial design
Randomized [R]
Sample size range [SS]
Analyzed [A]
Withdrawals [W]
Inclusion criteriaIntervention: drug; dose; delivery device
Time pre-ECT
Comparison
ECT: type
Withheld asthma med
Definition EIA (% fall FEV1)Outcomes:
Primary
Secondary
Adverse events (N=studies)
Spooner76,104 2002
N=21 (20 in the MA)
North America=1, Europe=18, Australia=2
1987–1995
20 journal articles; 1 unpublished thesis
C: N=11
A: N=10
Funding NR
All crossover trials
R=280
SS=8–24 (mean 14)
A=279
W=1
Reproducible EIA
Stable asthma
Lung function >70% predicted; variability between challenges <10–15%
N=1 Olympic athletes
N=20 physical conditioning NR
NCS: 1 mg, N=1; 2 mg, N=3; 4 mg, N=20; 8 mg, N=2
MDI, N=21; MDI plus spacer, N=5
Time pre-ECT
15 min, N=3; 20 min, N=8; 30 min, N=9; 60 min, N=1; 120–150 min, N=3; 240–270 min, N=2
Placebo
Inclined treadmill N=17; FRAST N=1; Bicycle ergometer N=1; Sport specific N=1
All asthma meds stopped appropriately for 6 h to 1 wk; some allowed ICS to continue
Max % fall FEV1 or PEF ≥15% N=11 ≥20%: N=9Primary: mean max % fall: FEV1, N=1 7; PEF: N=7
Secondary: clinical protection ( 50%); mean % protection; time course analysis
AE reported in 12/20 trials; 7/12 none observed; 5/12 reported bad taste, throat irritation, cough
Kelly77,161 2000
N=9 (8 in the MA)
North America=1; Europe=7; Australia=1
1987–1995
8 journal articles; 1 abstract
C: N=5
A: N=3
Mixed N=1
Funding NR
All crossover trials
R=162
SS=8–45
A=162
W=unclear
Hx EIA
Stable asthma
Atopic
Baseline FEV1
>70% predicted, and vary <10% from previous study day
No URIs in last 3 wk
Non-smokers
NCS: 4 mg, N=7; 8 mg, N=1
SCG: 4 mg, N=1; 10 mg, N=6; 20 mg, N=1; dose NR, N=1
MDI N=8; MDI plus spacer N=4
Time pre-ECT
15 min, N=1; 20 min, N=5; 30 min, N=2; 120 min, N=1;140 min, N=1; 240 min, N=1
Inclined treadmill: N=8
Most meds stopped appropriately for 4 hr to 1 wk; some allowed ICS to continue
Max % fall FEV1 or PEF
≥15% N=7; ≥20% N=1; NR N=1
Primary: mean max % fall: FEV1 N=7
Secondary: clinical protection N=5; complete protection N=7
AE reported in 3/8 trials; 1/3 none observed; 2/3 observed unpleasant taste, throat irritation
Spooner78 2003
24
North America =3; Europe =17; Asia=2; Australia=2
1976–1998
24 journal articles
C: N=13
A: N=11
Funding NR
Crossover: N=22; Parallel: N=2
R=518
SS=7–100
A=505
W=5 trials reported total of 13 withdrawals
Hx of asthma and/or EIA
CS oral and inhaled use varied (never, none in past 2 mo., or currently taking)
Lung function >50% predicted; variability between challenges <10‐ 15%
MCS N=24
SCG N=23, 2–40 mg
NCS: N=1, 4 mg AC N=11
IB: N=8, 0.12–2 mg Atropine: N=2, 0.2% OB: N=1, 0.02 mg MCS vs. AC N=11
SCG vs. SABA N=20; Fen N=6, 0.1–2 mg Sal N=10, 0.2–2.5mg Terbutaline N=2 Reproterol, procaterol, isoproterenol N=1 each
SCG vs. SCG plus SABA
N=10
Combination doses SCG 1–20mg; Fen N=4, 0.05–0.4 mg Sal N=3, 0.2–2.5mg Terbutaline N=1, 0.5mg Reproterol N=1, 1.0mg
Device
Nebulizer N=8; MDI N=5; spinhaler N=3; NR N=2; ≥2 devices N=6
Time pre-ECT
10 min N=4; 15 min N=6; 15–45 min N=1; 20 min N=3; 30 min N=6; 30–45 min N=1; 60 min N=2; 120 min oral N=1
Inclined treadmill: N=19
FRAST: N=1
Bicycle ergometer: N=3
Stair climbing: N=1
Most meds stopped for 8 h to 1 wk; some allowed ICS to continue; 1 did not permit any meds throughout the trial
Max % fall
FEV1 or PEF
≥10% N=1
≥15% N=5
≥20% N=13
≥25% N=1
≥30% N=1
NR=3
Primary: FEV1 (N=16); max % fall N=14; % predicted N=1; change N=1; max % fall PEF N=8
Secondary: complete protection; clinical protection
AE reported in 11/24 trials; 7/11 none observed; 2/7 tremor and distress/agitation on SCG or fenoterol; 1/7 mild throat irritation on SCG

AC = anticholinergic; AE = adverse events; BD = bronchodilator; ECT = exercise challenge test; EIA = exercise-induced asthma; Fen = fenoterol; FEV1 = forced expiratory volume in 1 second; FRAST = free running asthma screening test; hr = hour(s); Hx = history; MA = meta analysis; max = maximum; MCS = mast cell stabilizers; MDI = metered dose inhaler; min = minute(s); mg = milligram; NCS = nedocromil sodium; NR = not reported; PEF = peak expiratory flow; SABA = short-acting beta-agonist; Sal = salbutamol; SCG = sodium cromoglycate; URI = upper respiratory infection; wk = week(s)

From: 3, Results

Cover of Exercise-Induced Bronchoconstriction and Asthma
Exercise-Induced Bronchoconstriction and Asthma.
Evidence Reports/Technology Assessments, No. 189.
Dryden DM, Spooner CH, Stickland MK, et al.

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