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Table 3 Peak FEV1 [L] treatment comparisons by subgroups − FAS

From: Efficacy and safety of ipratropium bromide/albuterol compared with albuterol in patients with moderate-to-severe asthma: a randomized controlled trial

Subgroup

Subgroup level

Number of patients ALB-HFA 108/CVT-MDI 18/103

Subgroup by treatment interaction

Difference (CVT-MDI 18/103 – ALB-HFA 108)

 

p value*

Mean (SE)

95 % CI

P value

Onset of asthma

  

0.7890

   
 

Early

98/98

 

0.076 (0.024)

(0.028, 0.124)

0.0023

 

Late

117/114

 

0.078 (0.021)

(0.037, 0.118)

0.0003

Type of asthma (based on patient history)

  

0.3838

   
 

Allergic

182/181

 

0.082 (0.017)

(0.049, 0.116)

<.0001

 

Non−allergic

33/31

 

0.067 (0.035)

(−0.005, 0.138)

0.0679

% Predicted FEV1 categories

  

0.1378

   
 

≤45 %

17/19

 

0.004 (0.046)

(−0.094, 0.102)

0.9317

 

>45 % and ≤ 55 %

33/32

 

0.142 (0.040)

(0.060, 0.225)

0.0013

 

>55 % and ≤ 65 %

55/54

 

0.081 (0.029)

(0.022, 0.140)

0.0081

 

>65 % and ≤ 75 %

76/75

 

0.059 (0.020)

(0.018, 0.100)

0.0052

 

> 75 %

34/32

 

0.090 (0.053)

(−0.016, 0.196)

0.0949

Concomitant asthma medication usage

  

0.5364

   
 

ICS, with LABA

153/149

 

0.082 (0.018)

(0.047, 0.117)

<.0001

 

ICS, without LABA

62/63

 

0.071 (0.031)

(0.009, 0.132)

0.0251

Puff usage of medication (at baseline, daily average in week prior to visit 3)a

  

0.8736

   
 

≤4 puffs per 24 h day

143/141

 

0.074 (0.016)

(0.042, 0.107)

<.0001

 

>4 and <8 puffs per 24 h

71/70

 

0.094 (0.035)

(0.025, 0.164)

0.0083

 

≥8 puffs per 24 h day

1/1

    

Gender

  

0.1187

   
 

Female

125/127

 

0.090 (0.019)

(0.052, 0.127)

<.0001

 

Male

90/85

 

0.067 (0.024)

(0.018, 0.115)

0.0076

Raceb

  

0.0980

   
 

Amer.Ind./Alaska Nat

1/1

    
 

Asian

2/2

    
 

Black/African Amer.

42/40

 

0.188 (0.050)

(0.089, 0.288)

0.0004

 

Hawaiian/Pacif. Isle

4/5

    
 

White

166/164

 

0.063 (0.015)

(0.034, 0.092)

<.0001

Age category

  

0.7860

   
 

<35

44/41

 

0.077 (0.050)

(−0.023, 0.177)

0.1280

 

≥35,< 50

68/69

 

0.083 (0.031)

(0.022, 0.144)

0.0079

 

≥50,< 60

62/60

 

0.097 (0.022)

(0.053, 0.142)

<.0001

 

≥ 60

41/42

 

0.061 (0.030)

(0.001, 0.121)

0.0459

Smoking status

  

0.9106

   
 

Ex−smoker

59/59

 

0.075 (0.037)

(0.002, 0.149)

0.0436

 

Never smoked

156/153

 

0.076 (0.016)

(0.045, 0.107)

<.0001

FEV1/FVC [%] pre−BD at Rand

  

0.1852

   
 

<60

59/60

 

0.145 (0.036)

(0.074, 0.217)

0.0001

 

≥60,< 65

46/45

 

0.100 (0.029)

(0.041, 0.159)

0.0013

 

≥65,< 70

43/44

 

0.056 (0.031)

(−0.007, 0.119)

0.0785

 

≥ 70

67/63

 

0.013 (0.021)

(−0.028, 0.054)

0.5431

  1. ALB-HFA albuterol hydrofluoroalkaline, CVT-MDI ipratropium bromide/albuterol sulfate metered-dose inhaler, FAS full analysis set, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, ICS inhaled corticosteroids, LABA long-acting β2-agonist, pre-BD at Rand pre-bronchodilator at randomization
  2. aLast category not included in modelling due to insufficient number of patients
  3. bAsian, Hawaiian/Pacific Islander and American Indian/Alaska National not included in modelling due to insufficient number of patients
  4. *Unadjusted p values