Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

GlaxoSmithKline (GSK) logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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