A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Device: Marketed Nasal Strip; Device: Prototype Nasal Dilator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01495494

B3560692

Details and patient eligibility

About

This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Marketed nasal strip

Active Comparator group

Description:

Marketed nasal strip

Treatment:

Device: Marketed Nasal Strip

Prototype nasal dilator

Experimental group

Description:

Prototype nasal dilator

Treatment:

Device: Prototype Nasal Dilator