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. 2017 Dec 14;314(4):L529–L543. doi: 10.1152/ajplung.00465.2017

Table 3.

Summary of clinical trials: combination therapies

Measure, Test, and Assay
Study Name Treatment Trial Phase No. Mutations Age Group, yr Sample Size ppFEV1 BMI CFQ-R SwCl Conclusion (Failed or Approved) References
TRAFFIC/TRANSPORT (pooled results) LUM 600 mg qd + IVA 250 mg q12 h 3 Homozygous F508de1 ≥12 368 +3.3% (P < 0.001) [24] +0.28 kg/m2 (P < 0.001) [24] +3.1 points (P = 0.007) [24] Approved **
TRAFFIC/TRANSPORT (pooled results) LUM 400 mg qd + IVA 250 mg q12 h 3 Homozygous F508de1 ≥12 369 +2.8% (P < 0.001) [24] +0.24 kg/m2 (P < 0.001) [24] +2.2 points (P = 0.05) [24]
EVOLVE TEZ 100 mg qd + IVA 150 mg q12 h 3 Homozygous F508de1 ≥12 248 +4.0% (P < 0.0001) [24] +0.06 kg/m2 (P = 0.4127) [24] +5.1 points (P < 0.001) [24] (57, 58)
EXPAND TEZ 100 mg qd + IVA 150 mg q12 h 3 Homozygous F508de1 ≥12 161 +6.8% (P < 0.0001) [8] +11.1 points (P < 0.0001) [8]
**

http://www.glpg.com/docs/view/586fdcb9edc8a-en. Numbers within brackets indicate n.