Guideline topic: Pharmacological management of asthma
Evidence table 4.4j: Do Chromones work as first line preventor in children >5 years?

Author

Year

Study type

Quality rating

Population

Outomes measured

Effect size

Confidence intervals / p values

Comments

The CAMP study ¹

2000

Randomised, placebo controlled, partially blind study

BUD 400mcg/d v nedocromil (NS) 16mg/d v placebo for 4-6 years

++

Children 5-12 years, N= 1041, with mild to moderate asthma

Change in Lung function

BHR

Hospitalisations

Urgent caregiver visits

Beta2 rescue

Courses prednisone

% days needing extra medication

symptoms

No significant difference NS v placebo

Not significantly improved

No sign. reduction

Reduced, by 27% NS v placebo)

BUD reduced by 43% v placebo

Reduced; by 16% NS v placebo

reduced

NS

NS

p=0.02

NS

p=0.01

NS

NS

Children with mild to mod asthma NS reduced urgent care visits and courses of prednisolone but NOT as effective as BUD.

BUD give better asthma control than NS

Not fully a double blind study –

BUD v Placebo=blind

NS v Placebo=blind, but BUD v NS would not be blinded. Both placebo groups were merged for analysis

Stelmach ²

2001

Double blind RCT, placebo controlled.

NS 4mg BD v Placebo for 8 weeks

++

Children 9-16 y, N= 39, moderate atopic asthma

Clinical symptoms (aggreg. score 0-9)

Lung function and BHR

Markers inflammation

Reduction compared to baseline but NOT compared with placebo

FEV1 improved after NS and decreased with placebo

Comparison NS v placebo

P=0.24

No comparison with placebo given. NS improved values compared with baseline

Children seemed to have improved with NS compared with baseline, while those on placebo have some deteriorating parameters. Unfortunately comparative stats. Between effects with NS v placebo are not always given.

Armenio ³

1993

Double blind, placebo controlled RCT.

NS 4mg QDS v placebo for 12 weeks

++

Children, mild to moderate asthma, age 6-17 y. N=209.

Symptom, scores

PEFR (daily)

Total symptom scores reduced by 50% with NS compared to 9% with placebo

Significant treatment diff. NS v placebo (p<0.05) throughout the study

Konig ⁴

1995

Placebo controlled RCT

Nebubised NS v placebo for 24 weeks during the viral season

+

93 mild to moderate asthma, aged 6-12 y.

Symptoms

Freq. and duration viral induced wheezing episodes

Beta2 agonist use

PEFR

NS symptom free days =58% v placebo= 45%

Also improvement in : (NS v placebo)

day time scores

cough

NS did not prevent viral exacerbations but had more rapid resolution

NS – 10% reduced use v placebo = 24% increase use.

Improvement

P=0.027

P=0.03

P=0.027

NS

P=0.033

P=0.041