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| ID | Type | Description | Link |
|---|---|---|---|
| B3570876 | Other Identifier | GSK other Identifier |
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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)".
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathe Right Tan (small/medium) nasal strips | Device | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essex Testing Clinic, Inc | Verona | New Jersey | 07044 | United States | ||
| Radiant Research - Cincinnati |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31209698 | Derived | 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. |
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A total of 200 participants were screened. Out of which 140 participant were randomized in the study. 60 participants were not randomized as 52 of which did not meet study criteria, 2 had adverse event, 3 were lost to follow up, 2 withdrew consent and 1 because of other (unspecified) reason.
All participants were recruited from two centers in USA
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo Nasal Strip Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo Nasal Strip Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Score on Scale | At Baseline and Day 7 |
Approximately 21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| ID | Term |
|---|---|
| D003470 | Culture Media |
| ID | Term |
|---|---|
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D004864 | Equipment and Supplies |
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| Placebo nasal strip | Other | 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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| 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 |
| 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 |
| Cincinnati |
| Ohio |
| 45249 |
| United States |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | 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. | The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on Scale | At Baseline and Day 14 |
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| Primary | 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 | The ITT (N=140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on Scale | At Baseline and Day 7 |
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| Primary | 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 | The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on Scale | At Baseline and Day 14 |
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| Primary | 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. | The ITT (N= 140) population included all participants who were randomized into the study and had had at least one post-baseline efficacy assessment. | Posted | Count of Participants | Participants | At Day 7 |
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| Primary | 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. | The ITT (N= 140) population included all participants who were randomized into the study and hadat least one post-baseline efficacy assessment. | Posted | Count of Participants | Participants | At Day 14 |
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| Secondary | 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. | The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on Scale | At Baseline, Day 1, 3, 7 and 14 |
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| Secondary | 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. | The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on Scale | At Baseline, Day 1, 3, 7 and 14 |
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| Secondary | 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. | The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on Scale | At Baseline, Day 1, 3, 7 and 14 |
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| Secondary | 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. | The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on Scale | At Baseline, Day 1, 3, 7 and 14 |
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| Secondary | 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. | The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment. | Posted | Count of Participants | Participants | At Baseline, Day 1, 3, 7 and 14 |
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| 0 |
| 70 |
| 0 |
| 70 |
| 6 |
| 70 |
| EG001 | Placebo Nasal Strip Group | 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. | 0 | 70 | 0 | 70 | 7 | 70 |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| UPPER-AIRWAY COUGH SYNDROME | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| SINUSITIS | Infections and infestations | Systematic Assessment |
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| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
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| TONGUE ULCERATION | Gastrointestinal disorders | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | Systematic Assessment |
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| HEADACHE | Nervous system disorders | Systematic Assessment |
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| SINUS OPERATION | Surgical and medical procedures | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| Sleep Time Problems |
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| Symptoms on waking in the morning |
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| Practical Problems |
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| Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model | 0.2710 | Between treatment p-values. | LS mean difference | -0.86 | 2-Sided | 95 | -2.41 | 0.68 | Difference between treatments of LS mean change from baseline. | Superiority |
| Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model | 0.9236 | Between treatment p-values. | LS mean difference | -0.07 | 2-Sided | 95 | -1.60 | 1.45 | Difference between treatments of LS mean change from baseline. | Superiority |
| Treatment comparison of NRQLQ between active and placebo strip group for practical problems. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model | 0.8756 | Between treatment p-values. | LS mean difference | -0.05 | 2-Sided | 95 | -0.87 | 0.75 | Difference between treatments of LS mean change from baseline. | Superiority |
| Nasal congestion or stuffy nose |
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| Congestion in sinuses |
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| Takes time to clear nighttime drainage |
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| Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model. | 0.8005 | Between treatment p-values. | LS mean difference | -0.05 | 2-Sided | 95 | -0.45 | 0.35 | Difference between treatments of LS mean change from baseline. | Superiority |
| Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model. | 0.9613 | Between treatment p-values. | LS mean difference | 0.01 | 2-Sided | 95 | -0.38 | 0.40 | Difference between treatments of LS mean change from baseline. | Superiority |
| Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model | 0.4966 | Between treatment p-values. | LS mean difference | -0.14 | 2-Sided | 95 | -0.54 | 0.26 | Difference between treatments of LS mean change from baseline. | Superiority |
| Nasal congestion or stuffy nose |
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| Congestion in sinuses |
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| Takes time to clear nighttime |
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| Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model | 0.7747 | Between treatment p-values. | LS mean difference | -0.06 | 2-Sided | 95 | -0.47 | 0.35 | Difference between treatments of LS mean change from baseline. | Superiority |
| Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model. | 0.8535 | Between treatment p-values. | LS mean difference | 0.04 | 2-Sided | 95 | -0.39 | 0.47 | Difference between treatments of LS mean change from baseline. | Superiority |
| Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up. | ANCOVA | From ANCOVA model, baseline used as a covariate and site as a factor in the model. | 0.7720 | Between treatment p-values. | LS mean difference | -0.06 | 2-Sided | 95 | -0.47 | 0.35 | Difference between treatments of LS mean change from baseline. | Superiority |
| Improvement:all of items in sleep time problems |
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| Improvement:any of items in sleep time problems |
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| Improvement:all of items in symptom on walking(AM) |
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| Improvement:any of items in symptom on walking(AM) |
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| Improvement:all of the items in practical problems |
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| Improvement:any of the items in practical problems |
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| Chi-squared |
P-value are based on chi-square test. |
| 0.2368 |
| Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems. | Chi-squared | P-value are based on chi-square test | 0.4432 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems. | Chi-squared | P-value are based on chi-square test | 0.9856 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM. | Chi-squared | P-value are based on chi-square test. | 0.7854 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM. | Chi-squared | P-value are based on chi-square test | 0.4141 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems. | Chi-squared | P-value are based on chi-square test | 0.3028 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems. | Chi-squared | P-value are based on chi-square test | 0.3955 | Superiority |
| Improvement:all of items in sleep time problems |
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| Improvement:any of items in sleep time problems |
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| Improvement:all of items in symptom on walking(AM) |
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| Improvement:any of items in symptom on walking(AM) |
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| Improvement:all of the items in practical problems |
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| Improvement:any of the items in practical problems |
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| Chi-squared |
P-value are based on chi-square test |
| 0.6251 |
| Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems. | Chi-squared | P-value are based on chi-square test | 0.2381 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems. | Chi-squared | P-value are based on chi-square test | 0.4245 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM. | Chi-squared | P-value are based on chi-square test | 0.8213 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM. | Chi-squared | P-value are based on chi-square test | 0.1823 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems. | Chi-squared | P-value are based on chi-square test | 0.7744 | Superiority |
| Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems. | Chi-squared | P-value are based on chi-square test | 0.5811 | Superiority |
| Day 3 (Q1) |
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| Day 7 (Q1) |
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| Day 14 (Q1) |
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| Day 1 (Q3) |
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| Day 3 (Q3) |
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| Day 7 (Q3) |
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| Day 14 (Q3) |
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| Day 3 (Q1) |
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| Day 7 (Q1) |
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| Day 14 (Q1) |
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| Day 1 (Q3) |
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| Day 3 (Q3) |
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| Day 7 (Q3) |
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| Day 14 (Q3) |
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| Day 3 |
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| Day 7 |
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| Day 14 |
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| Day 3 |
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| Day 7 |
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| Day 14 |
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| Improvement from diary for openness (Day 1) |
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| Improvement from diary for easy to breath (Day 3) |
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| Improvement from diary for stuffed nose (Day 3) |
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| Improvement from diary for openness (Day 3) |
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| Improvement from diary for easy to breath (Day 7) |
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| Improvement from diary for stuffed nose (Day 7) |
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| Improvement from diary for openness (Day 7) |
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| Improvement from diary for easy to breath (Day 14) |
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| Improvement from diary for stuffed nose (Day 14) |
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| Improvement from diary for openness (Day 14) |
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