Early Airway Response to Allergen in Asthmatics (MK-0000-176)
Summary
This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.
Timeline
- Start
- 2010-06
- Primary completion
- 2011-02
- Completion
- 2011-03
Outcome
Mixed primary results
registry Placebo vs Nedocromil; p <0.0001; Difference in LS mean 16.22 (90% CI 10.74 to 21.69) NCT01061333 ↗
registry Placebo vs Mometasone; p = 0.0432; Difference in LS Mean 8.49 (90% CI 1.78 to 15.20) NCT01061333 ↗
registry Placebo vs Mometasone; p = 0.0860; Geom. Mean Ratio of fold over baseline 1.30 (90% CI 1.01 to 1.67) NCT01061333 ↗
registry Placebo vs Mometasone; p = 0.2679; Geom. Mean Ratio of fold over baseline 0.87 (90% CI 0.69 to 1.08) NCT01061333 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mometasone | Other / unclassified | 400 ug | Inhaled |
| Subject | Montelukast | Other / unclassified | 10 mg | Oral |
| Subject | Nedocromil | Small molecule | 4 mg | Inhaled |