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Guideline topic: Pharmacological management of asthma
Evidence table 4.7: High dose step-down

Author

Year

Study type

Quality rating

Population

Outomes measured

Effect size

Confidence intervals / p values

Comments

Adults

Reddel1

2000

RCT

+

61 adult asthmatics

Primary: bronchial reactivity

Secondary: PEF, mean bud dose

NS difference:

3200 mg daily vs 1600 mg daily.

3.2 vs 3.0 doubling doses

P=0.07

95% ci

Double blind study for first 8 weeks only, then single blind for 8 weeks, open label for 56 weeks. No difference in outcome measures between 2 high doses of inhaled budesonide.

Tukiainen2

 

2000

RCT, double blind, parallel group study. Budesonide 800mcg/day v 200mcg/day via Turbuhaler for 3 months

+

101 pts. Adults 18 – 68 years (mean approx 38yrs) diagnosed with asthma in last 3 months, symptoms of asthma < 6 months. Only requiring prn inhaled beta agonist

a)% predicted morning & evening PEFR at 12 weeks

b)treatment difference for PEFR

c)FEV1

d)day and night asthma sx

e)daily beta2agonist use

f)bronchial hyperresponsive

g)eosinophils

a)Approx 90% for both high and low dose

b)am = 1.1%
eve = 2.4%

c) no difference. approx 89% for both

d)no difference

e)no difference

f)no difference

g)more of a decrease in high dose

 

 

 

 

P=0.49,CI-2.1-4.3

P=0.10,CI-0.5-5.3

 

 

 

P= 0.02

Short term study thus exab. Rate not evaluated. Only significant difference was inflammatory markers

Van der Molen3

1998

RCT

++

84 adult asthmatics from 25 primary care centres.

Primary: am PEF

Secondary:

Sumptom score, spirometry

NS difference 800 mg daily vs 200 mg daily inh budesonide after 4 weeks and at 8 weeks after 200mg daily in goth groups. PEF 27 l/min vs 38 l/min

NS

95% ci

No difference in outcome measures between low and moderate doses of inhaled budesonide.

1. Reddel HK, Jenkins CR, Marks GB, Ware SI, Xuan W, Salome CM, et al. Optimal asthma control, starting with high doses of inhaled budesonide. Eur Respir J 2000;16(2):226-35.
2. Tukiainen H, Taivainen A, Majander R, Poussa T, Svahn T, Puolijoki H, et al. Comparison of high and low dose of the inhaled steroid, budesonide, as an initial treatment in newly detected asthma. Respir Med 2000;94(7):678-83.
3. van der Molen T, Meyboom-de Jong B, Mulder HH, Postma DS. Starting with a higher dose of inhaled corticosteroids in primary care asthma treatment. Am J Respir Crit Care Med 1998;158(1):121-5.

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