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. 2017 Mar 15;195(6):814–823. doi: 10.1164/rccm.201604-0700OC

Table 1.

Baseline Demographics and Characteristics (Modified Intention-to-Treat Population)*

  LAI (n = 44) Placebo (n = 45) Overall (n = 89) P Value
Race/ethnicity, n (%)       0.386
 White (not of Hispanic origin) 42 (95.5) 40 (88.9) 82 (92.1)  
 Hispanic 0 2 (4.4) 2 (2.2)  
 African 0 1 (2.2) 1 (1.1)  
 Asian 2 (4.5) 2 (4.4) 4 (4.5)  
Sex, n (%)       0.717
 Male 6 (13.6) 5 (11.1) 11 (12.4)  
 Female 38 (86.4) 40 (88.9) 78 (87.6)  
Height, cm, mean (SD) 165.4 (7.63) 164.2 (9.12) 164.8 (8.39) 0.503
Weight, kg, mean (SD) 59.71 (10.132) 60.15 (15.373) 59.93 (12.976) 0.874
BMI, kg/m2, mean (SD) 21.76 (2.705) 22.10 (3.941) 21.93 (3.372) 0.637
Age, yr, mean (SD) 58.0 (16.61) 59.1 (15.20) 58.5 (15.83) 0.745
FEV1 % predicted, mean (SD) 63.56 (21.339) 62.56 (17.168) 63.06 (19.239) 0.808
Stratification at screening, n (%)        
 Predominantly Mycobacterium avium complex 29 (65.9) 28 (62.2) 57 (64.0) 0.717
 Predominantly Mycobacterium abscessus 15 (34.1) 17 (37.8) 32 (36.0) 0.717
 CF 8 (18.2) 9 (20.0) 17 (19.1) 0.827
 M. avium complex and CF 2 (4.5) 1 (2.2) 3 (3.4) 0.544
 M. abscessus and CF 6 (13.6) 8 (17.8) 14 (15.7) 0.592
Mycobacterial load, n (%)       0.761
 Culture negative 3 (6.8) 3 (6.7) 6 (6.7)  
 Growth in liquid medium only 3 (6.8) 3 (6.7) 6 (6.7)  
 1–49 colonies 17 (38.6) 10 (22.2) 27 (30.3)  
 1+ (50–100 colonies) 2 (4.5) 4 (8.9) 6 (6.7)  
 2+ (>100–200 colonies) 2 (4.5) 2 (4.4) 4 (4.5)  
 3+ (>200–500 colonies) 3 (6.8) 4 (8.9) 7 (7.9)  
 4+ (>500 colonies) 14 (31.8) 19 (42.2) 33 (37.1)  
Cavitary disease 33 (75.0) 35 (77.8) 68 (76.4) 0.807
Macrolide resistant 8 (18.0) 15 (33.3) 23 (25.8) 0.146
Amikacin mutation positive 2 (4.5) 6 (13.3) 8 (8.9) 0.266
Macrolide resistant or amikacin mutation positive 9 (20.5) 16 (35.6) 25 (28.1)  

Definition of abbreviations: BMI = body mass index; CF = cystic fibrosis; LAI = liposomal amikacin for inhalation.

*

Baseline is defined as the measurement prior and closest to the administration of study drug.

At least two sputum samples (preferably three sputum samples) were obtained.

This designation included patients with primarily nodular bronchiectasis.