- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03549130
A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips)
Pivotal Subjective Sleep Study of a Nasal Dilator
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46240
- Concentrics Research
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New Jersey
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Paramus, New Jersey, United States, 07652
- TKL Research Inc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active nasal strip group
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
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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
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Placebo Comparator: Placebo nasal strip group
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Time Frame: At baseline and Day 7
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Participants scored all the domains of NRQLQ using same 7 points scales where 0=Not troubled and 6=extremely troubled.
Domains: 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.
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At baseline and Day 7
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Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Time Frame: At Baseline and Day 14
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Participants scored all the domains of NRQLQ using same 7 points scales where 0=Not troubled and 6=extremely troubled.
Domains: 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.
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At Baseline and Day 14
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Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Time Frame: At Baseline and Day 7
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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 night time drainage after waking up.
Lower scores indicate improvement in the rhinitis symptoms
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At Baseline and Day 7
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Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Time Frame: At Baseline and Day 14
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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 night time drainage after waking up.
Lower scores indicate improvement in the rhinitis symptoms
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At Baseline and Day 14
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Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Time Frame: At Day 7
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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.
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At Day 7
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Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Time Frame: At Day 14
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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.
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At Day 14
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202246
- B3570877 (Other Identifier: GSK other Identifier)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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