Congestion, NasalPhase 2NCT03549117

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

A Phase 2 study testing Breathe Right Tan (small/medium) nasal strips in people with Congestion, Nasal, run by GlaxoSmithKline at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Congestion, Nasal
What is being tested?: Breathe Right Tan (small/medium) nasal strips
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 2 sitesUnited States
Study dates: 25 Oct 2010to 14 Jan 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

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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:
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.
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.
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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Radiant Research - Cincinnati
Cincinnati, Ohio, 45249
Essex Testing Clinic, Inc
Verona, New Jersey, 07044

Other trials in United States

About this study

Official title: Pivotal Subjective Sleep Study of a Nasal Dilator

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)".

Read the 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.

Conditions: Congestion, Nasal
Being tested: Breathe Right Tan (small/medium) nasal strips, Placebo nasal strip
Medical subject headings: Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Breathe Right Tan (small/medium) nasal stripsDevice
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
Placebo nasal stripOther
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

Study groups in NCT03549117
Study group	Role	What they receive
Active nasal strip group	Experimental	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 Receives: Device: Breathe Right Tan (small/medium) nasal strips
Placebo nasal strip group	Placebo comparator	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 Receives: Other: Placebo nasal strip

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At Day 14

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Baseline, Day 1, 3, 7 and 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 201014 Jan 2011

First posted7 Jun 2018
Study start25 Oct 2010
Primary completion14 Jan 2011
Study completion14 Jan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Congestion, NasalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03549117
Sponsor's protocol ID: 202245
Other IDs: B3570876
Status last verified: Sep 2018
First submitted: 25 May 2018
Last updated: 25 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Noss MJ, Ciesla R, Shanga G. Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials. Adv Ther. 2019 Aug;36(8):1975-1985. doi: 10.1007/s12325-019-01005-5. Epub 2019 Jun 17.
PubMed 31209698

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal Subjective Sleep Study of a Nasal Dilator
ClinicalTrials.gov ID: NCT03549117
Acronym / sponsor ID: 202245
Conditions: Congestion, Nasal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 25 Oct 2010 (actual)
Primary completion: 14 Jan 2011 (actual)
Study completion: 14 Jan 2011 (actual)
First posted: 7 Jun 2018 (actual)
Results: Posted 25 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Active nasal strip group	Experimental	Device: Breathe Right Tan (small/medium) nasal stripsParticipants 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
Placebo nasal strip group	Placebo comparator	Other: Placebo nasal stripParticipants 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (22 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Breathe Right Tan (small/medium) nasal stripsParticipants 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	Device	Active nasal strip group
Placebo nasal stripParticipants 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	Other	Placebo nasal strip group

Primary outcome

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
Time frame: At Baseline and 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.
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
Time frame: At Baseline and 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.
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
Time frame: At Baseline and 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
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
Time frame: At Baseline and 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
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
Time frame: 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.
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
Time frame: 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.

5 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Baseline, Day 1, 3, 7 and 14

Results and safety

Results posted to the registry on 25 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Nasal Strip Group	70	69
Placebo Nasal Strip Group	70	70

Primary outcome: 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

Time frame: At Baseline and Day 7. Least squares mean (95% Confidence Interval). Unit: Score on Scale

Measure	Active Nasal Strip Group n = 70	Placebo Nasal Strip Group n = 70
Sleep Problems	-6.20 (-7.12 to -5.27)	-6.35 (-7.27 to -5.44)
Sleep Time Problems	-7.30 (-8.39 to -6.21)	-6.60 (-7.68 to -5.52)
Symptoms on Walking in the Morning	-7.18 (-8.20 to -6.17)	-7.00 (-8.01 to -5.99)
Practical Problems	-2.86 (-3.45 to -2.27)	-3.01 (-3.59 to -2.42)

Active Nasal Strip Group vs Placebo Nasal Strip Group: Least square (LS) mean difference: 0.15 (95% CI -1.14 to 1.45), p = 0.8142, ANCOVA
Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: -0.70 (95% CI -2.23 to 0.84), p = 0.3690, ANCOVA
Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: -0.18 (95% CI -1.61 to 1.25), p = 0.7995, ANCOVA

Population analysed: The Intent to treat (ITT) (n=140) population included all the participants who were randomized into the study and had at least one post-baseline efficacy assessment.

Primary outcome: 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

Time frame: At Baseline and Day 14. Least squares mean (95% Confidence Interval). Unit: Score on Scale

Measure	Active Nasal Strip Group n = 70	Placebo Nasal Strip Group n = 70
Sleep Problems	-7.14 (-8.10 to -6.18)	-6.96 (-7.91 to -6.02)
Sleep Time Problems	-8.31 (-9.41 to -7.21)	-7.44 (-8.53 to -6.36)
Symptoms on waking in the morning	-7.65 (-8.74 to -6.56)	-7.57 (-8.64 to -6.50)
Practical Problems	-3.48 (-4.06 to -2.90)	-3.42 (-3.98 to -2.85)

Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: -0.18 (95% CI -1.52 to 1.17), p = 0.7961, ANCOVA
Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: -0.86 (95% CI -2.41 to 0.68), p = 0.2710, ANCOVA
Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: -0.07 (95% CI -1.60 to 1.45), p = 0.9236, ANCOVA

Population analysed: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.

Primary outcome: 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

Time frame: At Baseline and Day 7. Least squares mean (95% Confidence Interval). Unit: Score on Scale

Measure	Active Nasal Strip Group n = 70	Placebo Nasal Strip Group n = 70
Feel Tired and Unrefreshed	-1.73 (-2.01 to -1.44)	-1.75 (-2.03 to -1.46)
Nasal congestion or stuffy nose	-1.96 (-2.24 to -1.68)	-1.91 (-2.19 to -1.63)
Congestion in sinuses	-1.72 (-2.00 to -1.45)	-1.73 (-2.01 to -1.46)
Takes time to clear nighttime drainage	-1.76 (-2.04 to -1.47)	-1.62 (-1.90 to -1.34)

Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: 0.02 (95% CI -0.38 to 0.42), p = 0.9314, ANCOVA
Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: -0.05 (95% CI -0.45 to 0.35), p = 0.8005, ANCOVA
Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: 0.01 (95% CI -0.38 to 0.40), p = 0.9613, ANCOVA

Population analysed: The ITT (N=140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.

Primary outcome: 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

Time frame: At Baseline and Day 14. Least squares mean (95% Confidence Interval). Unit: Score on Scale

Measure	Active Nasal Strip Group n = 70	Placebo Nasal Strip Group n = 70
Feel Tired and Unrefreshed	-1.79 (-2.09 to -1.49)	-1.82 (-2.12 to -1.53)
Nasal congestion or stuffy nose	-2.05 (-2.35 to -1.76)	-1.99 (-2.28 to -1.70)
Congestion in sinuses	-1.81 (-2.12 to -1.51)	-1.85 (-2.15 to -1.56)
Takes time to clear nighttime	-1.98 (-2.27 to -1.69)	-1.92 (-2.20 to -1.63)

Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: 0.03 (95% CI -0.39 to 0.45), p = 0.8775, ANCOVA
Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: -0.06 (95% CI -0.47 to 0.35), p = 0.7747, ANCOVA
Active Nasal Strip Group vs Placebo Nasal Strip Group: LS mean difference: 0.04 (95% CI -0.39 to 0.47), p = 0.8535, ANCOVA

Population analysed: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 21 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Nasal Strip Group	0 of 70 (0%)	6 of 70 (8.6%)	0 of 70
Placebo Nasal Strip Group	0 of 70 (0%)	7 of 70 (10%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31209698Noss MJ, Ciesla R, Shanga G. Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials. Adv Ther. 2019 Aug;36(8):1975-1985. doi: 10.1007/s12325-019-01005-5. Epub 2019 Jun 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Breathe Right Tan (small/medium) nasal strips in people with Congestion, Nasal, run by GlaxoSmithKline at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: At Baseline and Day 7). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03549117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.