Table 3.
Effects of Combination Therapy Vs Single-Agent Comparators Delivered Through the Same Device
| Study ID | Study Population* | Treatment Arms | ||||
|---|---|---|---|---|---|---|
| MP400223 | (N=832) ≥18 years | Arms | MP-AzeFlu (N=207) | AZE (N=208) | FP (N=207) | Placebo (N=209) |
| rTNSS Mean CFB (SD) | −5.5 (5.2) | −4.1 (4.6) | −5.0 (4.7) | −2.6 (3.9) | ||
| MP4004 (Meltzer et al, 2012, Carr et al, 2012)12,23 | (N=779) ≥12 years | Arms | MP-AzeFlu (N=193) | AZE (N=194) | FP (N=189) | Placebo (N=200) |
| rTNSS Mean CFB (SD) | −5.6 (5.2) | −4.4 (4.6) | −5.0 (5.2) | −2.8 (3.9) | ||
| MP4006 (Carr et al, 2012)23 | (N=1791) ≥12 years | Arms | MP-AzeFlu (N=448) | AZE (N=445) | FP (N=450) | Placebo (N=448) |
| rTNSS Mean CFB (SD) | −5.6 (5.2) | −4.5 (4.8) | −5.1 (4.7) | −3.2 (4.3) | ||
| Meta-analysis (MP4002, MP4004, and MP4006)23 | (N=3398) | Arms | MP-AzeFlu (N=848) | AZE (N=847) | FP (N=846) | Placebo (N=857) |
| rTNSS Mean CFB (SD) | −5.7 (5.3) | −4.4 (4.8) | −5.1 (4.9) | −3.0 (4.2) | ||
Notes: Improvement in TNSS with MP-AzeFlu: Study MP4002: MP-AzeFlu > Placebo (p<0.001); MP-AzeFlu > FP (p<0.034); MP-AzeFlu > AZE (p<0.002). Study MP4004: MP-AzeFlu > Placebo (p<0.001); MP-AzeFlu > AZE (p<0.032); MP-AzeFlu > FP (p<0.038). Study MP4006: MP-AzeFlu > Placebo (p<0.001); MP-AzeFlu > AZE (p<0.016); MP-AzeFlu > FP (p<0.029). Meta-analysis of the 3 studies: MP-AzeFlu > Placebo (p<0.001); MP-AzeFlu > AZE (p<0.001); MP-AzeFlu > FP (p<0.001).
Abbreviations: *ITT, Intent to treat population; CFB, Change from baseline; RQLQ, Rhinoconjunctivitis quality of life questionnaire; SD, Standard deviation; rTNSS, Reflective total nasal symptom score.