A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips)

PHASE2CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

November 4, 2010

Primary Completion Date

February 17, 2011

Study Completion Date

February 17, 2011

Conditions
Congestion, Nasal
Interventions
DEVICE

Breathe Right Tan (small/medium) nasal strips

Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (Breathe Right Tan), small/medium sized outside of the nose, from alar crease to alar crease, as per dispensing instructions, prior to sleeping. Participants used their assigned strip every night, for approximately 8 hours, but no more than 12 hours per night, for two weeks

OTHER

Placebo nasal strip

Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips, small/medium sized outside of the nose, from alar crease to alar crease, as per dispensing instructions, prior to sleeping. Participants used their assigned strip every night, for approximately 8 hours, but no more than 12 hours per night, for two weeks

Trial Locations (2)

46240

Concentrics Research, Indianapolis

07652

TKL Research Inc, Paramus

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY