A 12-Week Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 mcg of OPN-375 Twice a Day (BID) in Adolescent Subjects With Chronic Rhinosinusitis Without Nasal Polyps
Optinose US Inc.
Summary
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.
Description
The primary objective of this study is to compare the efficacy of intranasal administration of OPN-375 (fluticasone propionate)186 µg twice a day (BID) versus placebo in adolescents with chronic rhinosinusitis (CRS) without nasal polyps (sNP) using the endpoint of change from baseline in CRS symptoms as measured by a 7-day average instantaneous composite score of nasal symptoms (CSS) at the end of Week 4. The CSS is the sum of scores assigned to the symptoms congestion, facial pain or pressure sensation, and nasal discharge (anterior and/or posterior), on a scale of 0 (non-symptomatic) to 3 (s…
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening) 2. Female subjects, if sexually active, must: 1. 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 2. be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation,…
Interventions
- DrugOPN-375
OPN-375 (fluticasone propionate) delivered via exhalation delivery system (EDS) BID
- DrugPlacebo
Placebo solution administered via exhalation delivery system (EDS).
Locations (21)
- San Tan Allergy & AsthmaGilbert, Arizona
- Children's Hospital of Orange CountyOrange, California
- DaVinci Research, LLCSacramento, California
- Breathe Clear InstituteTorrance, California
- Children's Hospital ColoradoAurora, Colorado
- Colorado ENT & AllergyColorado Springs, Colorado