This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number of subjects is approximately 84 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 1:1 ratio (OPN-375 186 µg:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.
Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening)
be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], or male partner sterilization) before entry and throughout the study, or
be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
be abstinent.
Females who are pregnant or lactating.
Inability to have each nasal cavity examined for any reason, including nasal septum deviation.
Inability to achieve bilateral nasal airflow.
Is currently taking XHANCE®.