Astra Zeneca AIR

Study (No. patients)	Study design	Drugs/dosages	Age; severity of persistent asthma	Efficacy variables: statistically significant results	Safety results

Placebo-controlled studies

Campbell et al 1991 (n=141)	DB, R, PG 4+4 weeks	BUD 400 µg qd evening (could be increased to 400 µg bid after 4 weeks) vs Pl	Adults/ adolescents (>12 years) Mild asthma	Morning PEF: BUD > Pl at 4 and 8 weeks ß₂-agonist usage reduced with BUD vs baseline Reduced asthma symptoms in BUD vs Pl.	Tolerability: BUD = Pl Withdrawals: BUD 7, Pl 9 AE: BUD 18 (28%), Pl 18 (24%) SAE: BUD 1 (myocardial infarction not related to treatment)

Jones et al 1994 (n=340)	DB, R, PG 12 weeks	BUD: 400 µg qd a) morning and b) evening or 200 µg bid vs Pl	Adults/adolescents (>12 years) Mild/moderate stable asthma	Morning PEF: all BUD groups > Pl; no significant differences between BUD groups	400 µg qd morning (n=84), 400 µg evening (n=85), 200 µg b.i.d (n=86)., Pl (n=85): Asthma deterioration: 3, 6, 0, 9 Total number of withdrawals: 22, 14, 17, 23 SAE: 0, 3, 2, 2 (causal relationship unlikely in each case) Withdrawals because of AE: 5, 2, 5, 2

Banov et al 2001 (n=177)	DB, R, PG 12 weeks	BUD 400 µg qd vs Pl	Adults Moderate/severe asthma	Change from baseline FEV₁: BUD > Pl Morning and evening PEF: BUD > Pl ß-agonist use: BUD > Pl Day and nighttime symptoms: BUD > Pl	AE: profile similar in both treatment groups SAE: BUD 1 Discontinuations: BUD 3, Pl 4

Jónasson et al 1998 (n=163)	DB, R, PG 12 weeks	BUD: 100 µg or 200 µg morning qd or 100 µg bid vs Pl	Children (7-16 years) Mild asthma	Morning PEF BUD qd = BUD bid = Pl FEV₁ and PC₂₀ methacholine: BUD 100 µg bid > Pl Max fall in FEV₁ after exercise: all BUD groups > Pl	AE: profile similar in all 4 treatment groups No patients withdrew because of side-effects

Jónasson et al 2000 (n=122)	DB, R, PG 24 months	BUD: 100 µg or 200 µg morning qd or 100 µg bid vs Pl	Children (7-16 years) Mild asthma	Max fall in FEV₁ after exercise: all BUD groups > Pl	Withdrawals: 33 patients, 19 because of disease deterioration (2 in BUD 100 µg bid, 3 in 100 µg qd, 6 in 200 µg qd, 8 in placebo group)

Comparative studies without placebo

Herjavecz et al 1999 (n=181)	DB, R, PG (6 weeks) + O (16 weeks)	BUD as follows: Week 1-6: 400 µg evening qd or 200 µg b.i.d; Week 7-14: 200 µg evening q.d; Week 15-22: 100 µg evening qd	Adults Mild asthma	Morning and evening PEF: BUD qd = BUD bid Asthma symptoms, use of ß2-agonists: BUD qd = BUD bid	SAE: 1 in each group AE week 1-6: qd 50, bid 86 Discontinuations week 1-6: qd 16, bid 11, one in each group because of asthma deterioration, and one in each group because of AE. Discontinuations weeks 1-22: qd 9, (one because of AE and 2 because of asthma deterioration), bid 14 (6 because of asthma deterioration)

van der Molen et al 1998 (n=84)	DB, R, PG (4 weeks) + O (8 weeks)	Week 1-4: BUD 100 µg bid or 400 µg b.i.d; Week 5-12: BUD 200 µg morning qd	Adults Newly diagnosed mild asthma	Morning and evening PEF: unchanged when patients changed from 100 µg bid (4 weeks) to BUD 200 µg qd (8 weeks) .	No SAEs Predictable AEs were infrequent Two cases of mild hoarseness - one in each group

Herrera-Gatmaytan et al 2000 (n=60)	O, R, PG 8 weeks	BUD: 400 µg qd (15:00) or 200 µg bid	Children (6-17 yrs) Mild/moderate asthma	Change in morning and evening PEF: BUD qd = BUD bid FEV₁, asthma symptoms, use of ß₂-agonists: BUD qd = BUD bid	No AEs attributable to treatment. Nobody discontinued the study because of side-effects

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