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Table 2 FEV1 AUC0−6 [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

  

0.0463

   
 

Early

98/98

 

0.114 (0.024)

(0.067, 0.161)

<.0001

 

Late

117/114

 

0.063 (0.016)

(0.031, 0.095)

0.0002

Type of asthma (based on patient history)

  

0.6444

   
 

Allergic

182/181

 

0.089 (0.015)

(0.060, 0.119)

<.0001

 

Non−allergic

33/31

 

0.079 (0.036)

(0.005, 0.154)

0.0364

% Predicted FEV1 categories

  

0.3127

   
 

≤45 %

17/19

 

0.044 (0.046)

(−0.056, 0.144)

0.3562

 

>45 % and ≤55 %

33/32

 

0.138 (0.037)

(0.062, 0.214)

0.0011

 

>55 % and ≤65 %

55/54

 

0.094 (0.030)

(0.034, 0.154)

0.0026

 

>65 % and ≤75 %

76/75

 

0.073 (0.020)

(0.032, 0.113)

0.0006

 

>75 %

34/32

 

0.061 (0.033)

(−0.005, 0.127)

0.0683

Concomitant asthma medication usage

  

0.7610

   
 

ICS, with LABA

153/149

 

0.090 (0.018)

(0.055, 0.125)

<.0001

 

ICS, without LABA

62/63

 

0.074 (0.018)

(0.037, 0.110)

0.0001

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

  

0.9938

   
 

≤4 puffs per 24 h day

143/141

 

0.080 (0.016)

(0.048, 0.111)

<.0001

 

>4 and <8 puffs per 24 h

71/70

 

0.094 (0.027)

(0.040, 0.148)

0.0010

 

≥8 puffs per 24 h day

1/1

    

Gender

  

0.2585

   
 

Female

125/127

0.2585

0.091 (0.015)

(0.060, 0.121)

<.0001

 

Male

90/85

 

0.082 (0.023)

(0.036, 0.128)

0.0007

Raceb

  

0.1311

   
 

Amer.Ind./Alaska Nat

1/1

    
 

Asian

2/2

    
 

Black/African Amer.

42/40

 

0.164 (0.041)

(0.082, 0.247)

0.0002

 

Hawaiian/Pacif. Isle

4/5

    
 

White

166/164

 

0.074 (0.014)

(0.046, 0.102)

<.0001

Age category

  

0.7044

   
 

<35

44/41

 

0.076 (0.051)

(−0.028, 0.180)

0.1464

 

≥35, <50

68/69

 

0.082 (0.020)

(0.042, 0.123)

0.0001

 

≥50, <60

62/60

 

0.115 (0.022)

(0.071, 0.159)

<.0001

 

≥60

41/42

 

0.074 (0.027)

(0.019, 0.129)

0.0094

Smoking status

  

0.9982

   
 

Ex-smoker

59/59

 

0.077 (0.026)

(0.026, 0.128)

0.0038

 

Never smoked

156/153

 

0.088 (0.016)

(0.057, 0.119)

<.0001

FEV1/FVC [%] pre−BD at Rand

  

0.1453

   
 

<60

59/60

 

0.132 (0.027)

(0.079, 0.186)

<.0001

 

≥60, <65

46/45

 

0.117 (0.026)

(0.063, 0.170)

<.0001

 

≥65, <70

43/44

 

0.074 (0.029)

(0.015, 0.132)

0.0148

 

≥70

67/63

 

0.022 (0.024)

(−0.025, 0.070)

0.3506

  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
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BMC Pulmonary Medicine

ISSN: 1471-2466

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