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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01495494

Enrollment

Registered

2011-12-20

Start date

2009-11-30

Completion date

2009-11-30

Last updated

2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Nasal Strip

Brief summary

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

Interventions

DEVICEMarketed Nasal Strip

Breathe Right Nasal Strips - Clear small/medium strip

DEVICEPrototype Nasal Dilator

Prototype Nasal Dilator AB2R11

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects

Design outcomes

Primary

Measure	Time frame
Dermal response score of the application site of the nasal strip	Baseline through 7 days

Secondary

Measure	Time frame
Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip	7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026