A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips)
Condition: Congestion, Nasal
Intervention: Breathe Right Tan (small/medium) nasal strips; Placebo nasal strip
Intervention description: 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; 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind, parallel group, placebo-controlled study assessed subjective
      measures of nasal airway breathing immediately after application in the morning upon
      awakening after use of breathe right nasal strips (BRNS). Participants who met the entrance
      criteria, were currently suffering from nasal congestion, reported trouble with their sleep
      and had baseline nasal openness scores at bedtime during the qualification phase of ≤ 70 on a
      100-point Visual Analogue Scale (VAS) on at least four of seven qualification nights were
      randomized to one of two treatments for use at home. Participants returned to the study site
      after 7 and 14 days of nightly nasal strip use, respectively. At the two return visits, a
      validated subjective questionnaire, the Nocturnal Rhinoconjunctivitis Quality of Life
      Questionnaire (NRQLQ), measured response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consent: Demonstrated understanding of the study and willingness to participate as
             evidenced by voluntary written informed consent and has received a signed and dated
             copy of the informed consent form.

          -  Compliance: Understands and is willing, able and likely to comply with all study
             procedures and restrictions.

          -  General Health: Good general health with (in the opinion of the investigator) no
             clinically significant and relevant abnormalities of medical history or physical
             examination.

          -  Contraception: Females of childbearing potential who are, in the opinion of the
             investigator, practicing a reliable method of contraception.

          -  Leptorrhine Nose: Has a leptorrhine nose as defined in Appendix I to this protocol
             (nasal tip protrusion index of 45 or greater)

          -  Chronic Nasal Congestion: Complains of chronic nocturnal nasal congestion for at least
             the last year. When experiencing nasal congestion, complains always or almost always
             every night.

          -  Sleep: Reports trouble with sleep.

          -  VAS Nasal Openness Qualifying Question: Has baseline nasal openness scores at bedtime
             during the one-week baseline qualification phase of ≤ 70 on a 100-point VAS where
             0=extremely blocked and 100=extremely open on at least four of seven nights.

        Exclusion Criteria:

          -  Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds), allergy or atopic reaction to adhesive
             bandages or latex.

          -  Participant has current or a history of skin cancer, chronic skin condition, or eczema
             on the face or nose.

          -  Participant has visible open sores, sunburn, irritation on the face or nose
             immediately prior to randomization.

          -  Participant has been diagnosed with sleep apnea in a sleep laboratory.

          -  Participant has had a diagnosis of another major sleep disorder (i.e. primary
             insomnia, i.e. regularly sleeping less than six hours per night, sleep insufficiency,
             i.e. sleeping >two hours more on non-work days as compared to work days, narcolepsy,
             restless leg syndrome, or periodic limb movement disorder).

          -  Participant has a non-typical sleep schedule (e.g. shift-work).

          -  Participant plans travel involving time-zone changes during the study period.

          -  Regular/habitual consumption of more than five cups or glasses per day of
             xanthine-containing beverages (i.e. tea, coffee, cola).

          -  Participant currently uses any product or medication that has an effect on nasal
             congestion or sleep. Participant must have discontinued use of the following products
             according to the timings specified below:

             a) Prior to initiation of the baseline qualification phase: i. Use of any substance
             with psychotropic effects or properties known to affect sleep/wake, including but not
             limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines,
             stimulants, antidepressants, clonidine, barbiturates, anxiolytics, thalidomide,
             hypnotics and sedatives. Use of over-the-counter (OTC) sleep promoting agents
             including diphenhydramine, doxylamine, tryptophan, valerian root, kava kava,
             melatonin, St John's Wort and Alluna. Use of OTC alertness aids including caffeine and
             guarana.

        ii. Lubricating sprays/rinses/throat strips iii. Devices prescribed or used for sleep
        disordered breathing including Continuous Positive Airway Pressure (CPAP), mandibular
        advancement devices, tongue displacement devices iv. Use of any intranasally administered
        medications (e.g. Miacalcin) b) Within 3 days prior to the initiation of the baseline
        qualification phase: i. Oral decongestants ii. Short-acting prescription and
        non-prescription antihistamines, including ocular preparations and antihistamines contained
        in OTC sleep medications or 'night time' pain formulations (e.g. Benadryl, Chlortrimeton,
        Dimetane, Tavist) iii. Intranasal, oral or inhaled anticholinergics (e.g. Atrovent) iv.
        Long-acting beta agonists (e.g. Serevent) v. Oral antileukotrienes c) Within 7 days prior
        to the initiation of the baseline qualification phase: i. Any topical nasal decongestants
        (nasal sprays, drops, etc). ii. OTC products such as chin straps, pillows,
        internal/external nasal dilators.

        d) Within 10 days prior to initiation of the baseline qualification phase: i. Long-acting
        antihistamines (e.g. Allegra, Claritin, Clarinex, Zyrtec). e) Within 14 days prior to
        initiation of the baseline qualification phase: i. Intranasal cromolyn ii. Intranasal
        antihistamines (e.g. Astelin, Astepro) f) Within 4 weeks prior to the initiation of the
        baseline qualification phase: i. Intranasal corticosteroids g) Within 8 weeks prior to the
        initiation of the baseline qualification phase: i. Inhaled oral, intramuscular,
        intravenous, ocular and/or dermatological corticosteroid (with the exception of 1% or less
        topical hydrocortisone products) h) Within 3 months prior to the baseline qualification
        phase: i. Intranasal vaccines.

          -  Participant has experienced an acute upper respiratory tract infection during the
             qualification phase and/or at the Baseline visit.

          -  Participant abuses alcohol (regularly drinks more than 3 drinks per day) or has a
             recent history (within last 2 years) of substance or alcohol abuse

          -  Participant has a positive urine drug screening result (dipstick) for drugs of abuse
             (cannabinoids, opiates, amphetamines, methamphetamine, cocaine, barbiturates,
             methadone and/or its metabolites, ecstasy).

          -  Participant has self-reported severe, unstable disease states (e.g. myocardial
             infarction, congestive heart failure, diabetes, cirrhosis, cancer, epilepsy, or
             stroke), pain syndromes, (e.g. fibromyalgia) or any medical or surgical condition that
             places the Participant at unacceptable risk if he/she were to participate in the study
             or confounds the ability to interpret data from the study or who in the judgement of
             the principal investigator would not be suitable for entry into this study.

          -  Severe nasal obstruction caused by structural abnormality that renders the Participant
             unsuitable for the study in the opinion of the investigator, i.e. significant nasal
             polyps, severe deviated septum.

          -  Participant who is pregnant or nursing, by self-report.

          -  Participation in another clinical study.

          -  Receipt of an investigational drug within 30 days of the start of the baseline
             qualification phase.

          -  Previous participation in this study.

          -  Personnel: An employee of the sponsor or the study site or members or their immediate
             family.