EXCEL: Regular maintenance therapy with salmeterolFluticasone propionate combination SFC reduces exa

1
EXCEL Regular maintenance therapy with
salmeterol/Fluticasone propionate combination
(SFC) reduces exaserbations more effectively
than with formoterol/budesonide combination
(FBC).

• R Dahl
• EXacerbation Control Evaluated in a 6-month Long
  study

Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
2
Endpoints

• Primary
• Number of all asthma exacerbations experienced
• by the patient expressed as a rate over 24 weeks
• of treatment
• Other
• Comparison of treatments on other exacerbation
  parameters (severity, number, time to first),
  lung function (FEV1 and daily PEF), day and
  night-time asthma symptoms and rescue medication
  usage.

Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
3
Patients and Study Design

• This was a randomised, double-blind,
  double-dummy, parallel group study conducted in
  178 centres in
• 18 European countries.
• To be eligible patients had to be receiving
  1000-2000 ?g /day BDP or equivalent for at least
  4 weeks prior to Visit 1 and demonstrate a
  reversible increase in FEV1 of at least 12 (and
  ?200mls) 15 minutes after inhaling 200-400?g
  salbutamol. In addition, a day plus night-time
  asthma symptom score of at least 2 on at least 4
  of the last 7 evaluable days of the run-in period
  was required.

Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
4
SFC 50/250µ
g
(
1
inhalation
bd
)
placebo
to
match FBC

Run
-
in
Period

FBC 4.5/160µg
(
2
inhalations
bd)
placebo to
match SFC

16 24
Weeks

-
2


0
4
8

Salbutamol prn
permitt
ed throughout the study

Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
5
Definition of Exacerbations Mild Morning PEF
gt20 below baseline (mean of last 7 days of
run-in) for ? 2 consecutive days, or gt 3
additional reliever occasions/24-hour period with
respect to baseline for ? 2 consecutive days, or
awakening at night due to asthma for ? 2
consecutive nights Moderate Deterioration in
asthma that qualified for treatment with oral
prednisolone 40-60mg per day for 10 days. This
was either morning PEF gt30 below baseline (mean
of last 7 days of run-in) for ? 2 consecutive
days, or a clinical deterioration assessed by the
investigating physician as requiring oral steroid
treatment. Severe Deterioration in asthma
that required hospital admission
Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
6
Table 1 Demography and Baseline Characteristics
Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
7
Figure 1Cumulative Plot of All Exacerbations
Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
8
Figure 2 Cumulative Plot of Moderate/Severe
Exacerbations
Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
9
Figure 3 Adjusted Moderate/Severe
Protocol-Defined Exacerbation Rates by Study
Interval
Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977
10
Conclusions

• Regular twice daily treatment with
  salmeterol/fluticasone or
• formoterol/budesonide over six months
  significantly
• improved asthma symptoms and lung function in
  adults with
• moderate asthma.
• The rate of exacerbations was reduced over time
  on both
• treatments.
• Post hoc analysis showed that
  salmeterol/fluticasone was
• significantly superior to formoterol/budesonid
  e in reducing
• moderate/severe exacerbations over time.

Dahl R. et al. Eur Respir J 2004 24 (Suppl. 48)
309s-P1977