A Pivotal Subjective Sleep Study of a Nasal Dilator (Breathe Right Tan)

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, parallel group, placebo-controlled study assessed the effects of a novel nasal dilator strip in consumers with chronic nocturnal nasal congestion who have trouble with their sleep. Participants who met the entrance criteria were suffering from nasal congestion every night or almost every night, 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 where they self-administered the validated subjective questionnaire the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ).

Detailed Description
-----------------
The study had a screening phase, a one-week baseline qualification and a two-week treatment phase. Participants who met the entrance criteria, who were currently suffering from nasal congestion every night or almost every night, reported trouble with their sleep and had baseline nasal openness scores at bedtime during the qualification phase of ≤ 70 on a 100-point VAS on at least four of seven qualification nights were randomized to one of two treatments for use at home. During the two-week in-home treatment phase, daily diaries measuring the perception of nasal breathing and nasal congestion using a VAS were completed. 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 NRQLQ, measured response.

Official Title
-----------------
Pivotal Subjective Sleep Study of a Nasal Dilator

Conditions
-----------------
Congestion, Nasal

Intervention / Treatment
-----------------
* Device: Breathe Right Tan (small/medium) nasal strips
* Other: Placebo nasal strip


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active nasal strip group<br>Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions | Device: Breathe Right Tan (small/medium) nasal strips<br>* 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<br>|
| Placebo Comparator: Placebo nasal strip group<br>Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions | Other: Placebo nasal strip<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7 | Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms. | At Baseline and Day 7 | 
| Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14 | Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms. | At Baseline and Day 14 | 
| Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7 | Participants scored for domain Symptoms on waking in the morning of NRQLQ using 7 points scale: 0=not troubled, 1=hardly troubled at all, 2=somewhat troubled, 3=moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Questionnaire for this domain included: Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms | At Baseline and Day 7 | 
| Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14 | Participants scored for domain Symptoms on waking in the morning of NRQLQ using 7 points scale: 0=not troubled, 1=hardly troubled at all, 2=somewhat troubled, 3= moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Questionnaire for this domain included: Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms | At Baseline and Day 14 | 
| Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7 | Participants scored all the domains of NRQLQ using 7 points scale,0=Not troubled,1=hardly troubled at all,2=somewhat troubled,3=moderately troubled, 4=quite a bit troubled,5=very troubled,6=extremely troubled.Sleep problems (difficulty getting sleep,unable to get good night sleep/wake up during night, restless [tossing and turning],having to get up because stuffy nose or blow nose using score,scores range:Min-Max[0-24]),Sleep time problems(Nasal congestion or stuffy nose,sinus pressure or pain,runny nose,post-nasal drip[drainage down back of nose/throat],headache,scores range:0-30);Symptoms on waking in morning(Feel tired and unrefreshed,nasal congestion/stuffy nose,congestion in sinuses,takes time to clear nighttime drainage after waking up,scores range:0-24);practical problems(have to avoid symptom triggers[such as dust,cigarette smoke,strong smells,perfumes],rub nose/eyes,take medication,score range:0-18).Lower scores relative to baseline indicate improvement in rhinitis symptoms. | At Day 7 | 
| Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14 | Participants scored all the domains of NRQLQ using 7 points scale,0=Not troubled,1=hardly troubled at all,2=somewhat troubled,3=moderately troubled, 4=quite a bit troubled,5=very troubled,6=extremely troubled.Sleep problems (difficulty getting sleep,unable to get good night sleep/wake up during night, restless [tossing and turning],having to get up because stuffy nose or blow nose using score,scores range:Min-Max[0-24]),Sleep time problems(Nasal congestion or stuffy nose,sinus pressure or pain,runny nose,post-nasal drip[drainage down back of nose/throat],headache,scores range:0-30);Symptoms on waking in morning(Feel tired and unrefreshed,nasal congestion/stuffy nose,congestion in sinuses,takes time to clear nighttime drainage after waking up,scores range:0-24);practical problems(have to avoid symptom triggers[such as dust,cigarette smoke,strong smells,perfumes],rub nose/eyes,take medication,score range:0-18).Lower scores relative to baseline indicate improvement in rhinitis symptoms. | At Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night | Participants were asked how easy it was to breathe through their nose [Q1], how open your nose feels at this time [Q3] after strip application at night. The participants scored their responses on a 100 mm VAS scale where For Q1: 0 = extremely difficult to breathe and 100 = extremely easy to breathe. For Q3: 0=extremely blocked, 100=extremely open. | At Baseline, Day 1, 3, 7 and 14 | 
| Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning | Participants were asked how easy it was to breathe through their nose [Q1], how open your nose feels at this time [Q3] after strip application at night. The participants scored their responses on a 100 mm VAS scale where For Q1: 0 = extremely difficult to breathe and 100 = extremely easy to breathe. For Q3: 0=extremely blocked, 100=extremely open. | At Baseline, Day 1, 3, 7 and 14 | 
| Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Night | Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2). The participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. | At Baseline, Day 1, 3, 7 and 14 | 
| Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Morning | Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2). The participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. | At Baseline, Day 1, 3, 7 and 14 | 
| Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night | Participants were asked following daily diary VAS scale questions Q1 How easy it was to breathe through your nose, Q2 how stuffed their nose felt and Q3 How open their nose feels at this time. Q1 was scored using 100 mm VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. Q3 was scored using 100 mm VAS scale where 0=extremely blocked, 100=extremely open. Q2 was scored using a scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. | At Baseline, Day 1, 3, 7 and 14 |