Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Sleep Disorders; Congestion, Nasal

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01122849

B3570674

Details and patient eligibility

About

The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects with leptorrhine noses
• Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 3 patient groups, including a placebo group

Prototype Nasal Dilator

Experimental group

Description:

Prototype Nasal Dilator

Treatment:

Device: Prototype Nasal Dilator

Marketed Nasal Strip

Active Comparator group

Description:

Marketed Nasal Strip

Treatment:

Device: Marketed Nasal Strip

Placebo Nasal Strip

Placebo Comparator group

Description:

Placebo

Treatment:

Device: Placebo Nasal Strip