TABLE 4.
CHANGES FROM BASELINE IN THE SECONDARY OUTCOME VARIABLES WITH EACH TREATMENT OVER 14 WEEKS AND DIFFERENCES BETWEEN TREATMENTS
| LTRA/LABA
|
ICS/LABA
|
LTRA/LABA vs. ICS/LABA
|
||
|---|---|---|---|---|
| Variable | Change (95% CL) | Change (95% CL) | Difference (95% CL) | p Value |
| FEV1, L | −0.04 (−0.09, 0.01) | 0.05 (0.01, 0.09) | −0.09 (−0.15, −0.02) | 0.007 |
| FEV1, % predicted | −1.27 (−2.78, 0.25) | 1.54 (0.35, 2.74) | −2.81 (−4.69, −0.93) | 0.003 |
| Postsalmeterol FEV1, L | −0.12 (−0.17, −0.07) | −0.03 (−0.07, 0.01) | −0.09 (−0.15, −0.02) | 0.007 |
| a.m. peak flow, L/min | −5.69 (−25.46, 14.08) | 20.18 (14.80, 25.55) | −25.87 (−46.26, −5.48) | 0.011 |
| p.m. peak flow, L/min | −11.06 (−19.10, −3.02) | 9.96 (4.83, 15.09) | −21.02 (−30.32, −11.72) | < 0.001 |
| Peak flow variability, % | −1.11 (−2.34, 0.13) | −2.22 (−3.13, −1.31) | 1.11 (−0.44, 2.66) | 0.152 |
| Rescue use, no. daily puffs | 0.12 (−0.09, 0.33) | −0.25 (−0.41, −0.08) | 0.36 (0.10, 0.62) | 0.006 |
| Daily a.m. symptoms (0–3) | 0.02 (−0.03, 0.06) | −0.05 (−0.08, −0.01) | 0.06 (0.01, 0.12) | 0.025 |
| ACQ* | 0.01 (−0.16, 0.17) | −0.21 (−0.35, −0.08) | 0.22 (0.01, 0.43) | 0.038 |
| AQLQ† | 0.05 (−0.11, 0.21) | 0.14 (0.01, 0.26) | −0.09 (−0.29, 0.11) | 0.370 |
| ASUI‡ | −0.01 (−0.04, 0.02) | 0.03 (0.01, 0.055) | −0.04 (−0.08, 0.00) | 0.057 |
| Exhaled nitric oxide difference from baseline, ppb§ | 3.23 (0.05, 6.40) | −2.69 (−5.44, 0.06) | 5.91 (1.59, 10.24) | 0.006 |
| Salmeterol-protected methacholine PC20 (n = 88)‖¶ | −1.46 (−1.85, −1.08) | −0.47 (−0.80, −0.14) | −0.99 (−1.45, −0.54) | < 0.0001 |
| Sputum eosinophils, % (n = 60)¶ | 0.80 (0.30, 1.60) | 0.15 (0.0, 0.25) | 0.70 (0.20, 1.40) | 0.0019 |
| Sputum ECP, μg/L (n = 53)¶ | 133 (79, 191) | 10 (−4, 42) | 90 (17, 166) | 0.0147 |
| Sputum tryptase, μg/L (n = 53)¶ | 5.5 (3.3, 9.4) | 0.2 (0.0, 0.5) | 5.0 (3.0, 8.1) | < 0.0001 |
Definition of abbreviations: ACQ = Asthma Control Questionnaire; AQLQ = asthma quality of life questionnaire; ASUI = asthma symptoms utility index; CL = confidence limits; ECP = eosinophil cationic protein; ICS = inhaled corticosteroids; LABA = long-acting β-agonist; LTRA = leukotriene receptor antagonist.
Unless otherwise noted, values represent the results of a modeled, intent-to-treat analysis; n = 190.
Scale: 0–6; higher scores indicate poorer control.
Scale: 1–7; higher scores indicate improved asthma-related quality of life.
Scale 0–1: higher scores indicate fewer symptoms.
Measured at 350-ml/s expiratory flow rate.
Values represent doubling dilution changes; negative values indicate increased responsiveness.
Aligned analysis of the individuals with complete data.