An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Device: Marketed nasal strip; Device: NexGen JB Organic PET/PE; Device: NexGen AB 2R11

Study type: Interventional

Funder types: Industry

Identifiers

NCT01105949

B3560645

Details and patient eligibility

About

The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history

Exclusion criteria

• Currently experiencing cold or flu
• History of perennial or allergic rhinitis or rhinitis medicamentosa
• Evidence of nasal polyps as documented by anterior rhinoscopy
• Evidence of significant nasal tract structural malformations including a severe deviated septum (where subjects are indicated for surgery) or a concha bullosa as documented by anterior rhinoscopy
• Visible open sores, sunburn, irritation, eczema or chronic skin condition on the face to nose
• Bacterial sinusitis infection during 2 weeks prior to entry in the baseline phase of the study
• Any other condition that in the opinion of the investigator would have an affect on nasal breathing
• Use of any product containing menthol within two hours prior to any subjective measures involved in the study
• Had an allergic contact dermatitis on the face within 30 days prior to entry
• History of chronic or active skin or other immunologic (rheumatoid, psoriasis) disease
• History of skin cancer
• Use of antibiotics or alpha adrenergic drugs (all forms) within 1 week prior to entry in the baseine phase of the study
• Use of glucocorticosteroids (all forms) within 1 month prior to entry in the baseline phase of the study
• Any current treatment which in the opinion of the investigator will affect nasal congestion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Marketed nasal strip

Other group

Description:

Marketed nasal strip

Treatment:

Device: Marketed nasal strip

NexGen JB Organic PET/PE

Experimental group

Description:

NexGen JB Organic PET/PE, prototype nasal dilator strip

Treatment:

Device: NexGen JB Organic PET/PE

NexGen AB 2R11

Experimental group

Description:

NexGen AB 2R11

Treatment:

Device: NexGen AB 2R11