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. Author manuscript; available in PMC: 2010 Nov 5.
Published in final edited form as: N Engl J Med. 2009 Apr 9;360(15):1487–1499. doi: 10.1056/NEJMoa0806290

Table 2.

Episodes of Poor Asthma Control

N Treatment Group
IRR* (Eso:Plb) 95% CI P-value*
Placebo
193
Esomeprazole
200
Eso vs Plb GER Interaction


Asthma episodes - type 1
 #Events 201 224
  Rate (events/person-year) 2.3 2.5 1.1
0.8, 1.5
0.66 0.93
  Patients with ≥1 event, N(%) 42 42


Exacerbation Components Peak flow, 30% drop
  #Events 141 180
  Rate (events/person-year) 1.7 2.1 1.2
0.8, 2.0
0.35 0.99
  Patients with ≥1 event, N (%) 26 28


Urgent Care
  #Events 53 51
  Rate (events/person-year) 0.7 0.6 0.9
0.6, 1.5
0.79 0.44
  Patients with ≥1 event, N (%) 17 18


New use of oral steroids
  #Events 50 48
  Rate (events/person-year) 0.6 0.5 0.9
0.6, 1.3
0.62 0.84
  Patients with ≥1 event, N (%) 24 21

Asthma episodes - type 2
 #Events 367 383
  Rate (events/person-year) 4.4 4.3 1.0
0.8, 1.3
0.87 0.19
  Patients with ≥1 event, N (%) 63 60


Rescue medications
 #Events 248 241
  Rate (events/person-year) 3.0 2.8 0.9
0.7, 1.3
0.62 0.05
  Patients with ≥1 event, N (%) 46 45

Night awakening
 #Events 2,518 2,241
  Rate (events/person-year) 30 28 0.9
0.6, 1.4
0.71 0.38
  Patients with ≥1 event, N (%) 55 52
*

Incidence rate ratio and P-value estimated from negative binomial regression with robust variance estimates.

P-value for treatment effect (Esomeprazole - Placebo)

P-value for modification of treatment effect by pH probe results estimated by linear regression;