Congestion, Nasal
Conditions
Brief summary
This randomized, double-blind, parallel group, placebo-controlled study assessed subjective measures of nasal airway breathing immediately after application in the morning upon awakening after use of breathe right nasal strips (BRNS). Participants who met the entrance criteria, were currently suffering from nasal congestion, reported trouble with their sleep and had baseline nasal openness scores at bedtime during the qualification phase of ≤ 70 on a 100-point Visual Analogue Scale (VAS) on at least four of seven qualification nights were randomized to one of two treatments for use at home. Participants returned to the study site after 7 and 14 days of nightly nasal strip use, respectively. At the two return visits, a validated subjective questionnaire, the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), measured response.
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.
Interventions
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
OTHERPlacebo nasal strip
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
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At baseline and Day 7 | 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. |
| 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 | At Baseline and Day 14 | 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. |
| 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 | 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 night time drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms |
| 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 | 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 night time drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms |
| 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 | 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 Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14 | 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. |
Countries
United States
Participant flow
Recruitment details
All participants were recruited at two centers in USA.
Pre-assignment details
A total of 235 participates were screened, out of which 130 participants were enrolled and randomized in the study. 105 participants were not randomized as 104 of which did not meet study criteria, 1 had adverse event.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 64 |
| 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. | 64 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo Nasal Strip Group | Total | Active Nasal Strip Group |
|---|---|---|---|
| Age, Customized | 48.4 Years STANDARD_DEVIATION 13.74 | 47.8 Years STANDARD_DEVIATION 12.53 | 47.1 Years STANDARD_DEVIATION 11.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 107 Participants | 55 Participants |
| Sex: Female, Male Female | 44 Participants | 92 Participants | 48 Participants |
| Sex: Female, Male Male | 20 Participants | 36 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 |
| other Total, other adverse events | 6 / 64 | 2 / 64 |
| serious Total, serious adverse events | 0 / 64 | 0 / 64 |
Outcome results
Primary
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
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
Time frame: At Baseline and Day 14
Population: The ITT (N= 128) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Active Nasal Strip Group | 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 | Feel Tired and Unrefreshed | -1.65 Score on Scale |
| Active Nasal Strip Group | 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 | Congestion in sinuses | -1.71 Score on Scale |
| Active Nasal Strip Group | 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 | Takes time to clear nighttime | -1.93 Score on Scale |
| Active Nasal Strip Group | 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 | Nasal congestion or stuffy nose | -1.96 Score on Scale |
| Placebo Nasal Strip Group | 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 | Congestion in sinuses | -1.70 Score on Scale |
| Placebo Nasal Strip Group | 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 | Feel Tired and Unrefreshed | -1.46 Score on Scale |
| Placebo Nasal Strip Group | 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 | Nasal congestion or stuffy nose | -1.82 Score on Scale |
| Placebo Nasal Strip Group | 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 | Takes time to clear nighttime | -1.56 Score on Scale |
Comparison: Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.p-value: 0.303495% CI: [-0.57, 0.18]ANCOVA
Comparison: Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.p-value: 0.489195% CI: [-0.57, 0.27]ANCOVA
Comparison: Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.p-value: 0.949895% CI: [-0.43, 0.4]ANCOVA
Comparison: 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.p-value: 0.123595% CI: [-0.83, 0.1]ANCOVA
Primary
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
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
Time frame: At Baseline and Day 7
Population: The ITT (N= 128) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Active Nasal Strip Group | 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 | Feel Tired and Unrefreshed | -1.40 Score on Scale |
| Active Nasal Strip Group | 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 | Nasal congestion or stuffy nose | -1.71 Score on Scale |
| Active Nasal Strip Group | 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 | Congestion in sinuses | -1.59 Score on Scale |
| Active Nasal Strip Group | 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 | Takes time to clear nighttime drainage | -1.80 Score on Scale |
| Placebo Nasal Strip Group | 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 | Takes time to clear nighttime drainage | -1.33 Score on Scale |
| Placebo Nasal Strip Group | 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 | Congestion in sinuses | -1.04 Score on Scale |
| Placebo Nasal Strip Group | 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 | Nasal congestion or stuffy nose | -1.34 Score on Scale |
| Placebo Nasal Strip Group | 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 | Feel Tired and Unrefreshed | -1.15 Score on Scale |
Comparison: Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.p-value: 0.251395% CI: [-0.68, 0.18]ANCOVA
Comparison: Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.p-value: 0.074395% CI: [-0.78, 0.04]ANCOVA
Comparison: Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.p-value: 0.015895% CI: [-0.99, -0.1]ANCOVA
Comparison: 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.p-value: 0.048995% CI: [-0.94, 0]ANCOVA
Primary
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
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.
Time frame: At Baseline and Day 14
Population: The ITT (N= 128) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Active Nasal Strip Group | 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 | Sleep Problems | -6.34 Score On scale |
| Active Nasal Strip Group | 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 | Symptoms on Walking in the Morning | -7.25 Score On scale |
| Active Nasal Strip Group | 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 | Practical Problems | -3.47 Score On scale |
| Active Nasal Strip Group | 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 | Sleep Time Problems | -7.30 Score On scale |
| Placebo Nasal Strip Group | 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 | Practical Problems | -2.66 Score On scale |
| Placebo Nasal Strip Group | 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 | Symptoms on Walking in the Morning | -6.54 Score On scale |
| Placebo Nasal Strip Group | 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 | Sleep Problems | -5.87 Score On scale |
| Placebo Nasal Strip Group | 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 | Sleep Time Problems | -6.32 Score On scale |
Comparison: Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.p-value: 0.506395% CI: [-1.85, 0.92]ANCOVA
Comparison: Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.p-value: 0.249695% CI: [-2.64, 0.69]ANCOVA
Comparison: Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.p-value: 0.332595% CI: [-2.16, 0.74]ANCOVA
Comparison: Treatment comparison of NRQLQ between active and placebo strip group for practical problems.p-value: 0.108895% CI: [-1.81, 0.18]ANCOVA
Primary
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
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.
Time frame: At baseline and Day 7
Population: The ITT (N= 128) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Active Nasal Strip Group | 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 | Symptoms on waking in the morning | -6.49 Score on Scale |
| Active Nasal Strip Group | 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 | Sleep Time Problems | -6.30 Score on Scale |
| Active Nasal Strip Group | 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 | Practical problems | -2.98 Score on Scale |
| Active Nasal Strip Group | 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 | Sleep Problems | -4.94 Score on Scale |
| Placebo Nasal Strip Group | 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 | Practical problems | -2.28 Score on Scale |
| Placebo Nasal Strip Group | 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 | Sleep Problems | -4.17 Score on Scale |
| Placebo Nasal Strip Group | 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 | Symptoms on waking in the morning | -4.87 Score on Scale |
| Placebo Nasal Strip Group | 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 | Sleep Time Problems | -4.51 Score on Scale |
Comparison: Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.p-value: 0.244695% CI: [-2.06, 0.53]ANCOVA
Comparison: Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.p-value: 0.033395% CI: [-3.45, -0.14]ANCOVA
Comparison: Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.p-value: 0.034595% CI: [-3.13, -0.12]ANCOVA
Comparison: Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.p-value: 0.171195% CI: [-1.72, 0.31]ANCOVA
Primary
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
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.
Time frame: At Day 14
Population: The ITT (N= 128) population included all participants who were randomized into the study and had had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Nasal Strip Group | 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 | Improvement:any of items in sleep time problems | 60 Participants |
| Active Nasal Strip Group | 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 | Improvement:any of the items in practical problems | 55 Participants |
| Active Nasal Strip Group | 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 | Improvement:all of the items in sleep problems | 31 Participants |
| Active Nasal Strip Group | 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 | Improvement:any of the items in sleep problems | 59 Participants |
| Active Nasal Strip Group | 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 | Improvement:all of items in sleep time problems | 24 Participants |
| Active Nasal Strip Group | 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 | Improvement:all of items in symptom on walking(AM) | 35 Participants |
| Active Nasal Strip Group | 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 | Improvement:any of items in symptom on walking(AM) | 62 Participants |
| Active Nasal Strip Group | 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 | Improvement:all of the items in practical problems | 14 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:all of the items in practical problems | 13 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:all of items in symptom on walking(AM) | 39 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:all of items in sleep time problems | 26 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:any of the items in practical problems | 51 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:any of items in sleep time problems | 62 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:all of the items in sleep problems | 34 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:any of items in symptom on walking(AM) | 63 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:any of the items in sleep problems | 60 Participants |
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.p-value: 0.5958Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.p-value: 0.7296Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.p-value: 0.7171Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.p-value: 0.403Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.p-value: 0.4741Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.p-value: 0.5591Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.p-value: 0.8285Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.p-value: 0.3487Chi-squared
Primary
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
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.
Time frame: At Day 7
Population: The ITT (N= 128) population included all participants who were randomized into the study and had had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Nasal Strip Group | 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 | Improvement:all of the items in sleep problems | 20 Participants |
| Active Nasal Strip Group | 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 | Improvement:all of items in symptom on walking(AM) | 37 Participants |
| Active Nasal Strip Group | 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 | Improvement:any of items in symptom on walking(AM) | 60 Participants |
| Active Nasal Strip Group | 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 | Improvement:all of items in sleep time problems | 21 Participants |
| Active Nasal Strip Group | 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 | Improvement:all of the items in practical problems | 9 Participants |
| Active Nasal Strip Group | 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 | Improvement:any of the items in sleep problems | 59 Participants |
| Active Nasal Strip Group | 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 | Improvement:any of the items in practical problems | 53 Participants |
| Active Nasal Strip Group | 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 | Improvement:any of items in sleep time problems | 58 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:any of the items in practical problems | 48 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:all of items in symptom on walking(AM) | 28 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:any of the items in sleep problems | 61 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:all of items in sleep time problems | 17 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:any of items in sleep time problems | 61 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:any of items in symptom on walking(AM) | 58 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:all of the items in practical problems | 12 Participants |
| Placebo Nasal Strip Group | 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 | Improvement:all of the items in sleep problems | 21 Participants |
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.p-value: 0.8498Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.p-value: 0.4652Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.p-value: 0.439Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.p-value: 0.2997Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.p-value: 0.1116Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.p-value: 0.5101Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.p-value: 0.474Chi-squared
Comparison: Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.p-value: 0.2787Chi-squared