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Triamcinolone acetonide aqueous nasal spray improves nocturnal rhinitis-related quality of life in patients treated in a primary care setting: the Quality of Sleep in Allergic Rhinitis study

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Triamcinolone acetonide aqueous nasal spray improves nocturnal rhinitis-related quality of life in patients treated in a primary care setting: the Quality of Sleep in Allergic Rhinitis study
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  Triamcinolone acetonide aqueous nasal sprayimproves nocturnal rhinitis-related quality of lifein patients treated in a primary care setting:the Quality of Sleep in Allergic Rhinitis study Milton Mintz, DO*; Jorge Garcia, PhD†; Phyllis Diener, BS, MT†; Yuning Liao, PhD†;Leon Dupclay, PharmD, PhD†; and George Georges, MD† Background:  Sleep disturbances due to allergic rhinitis can contribute to daytime fatigue, impair mood, and decrease daytimefunctioning. Objective: To measure allergic rhinitis patients’ nocturnal rhinitis-related quality of life using a new, validated disease-specificinstrument, the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ). Methods:  This open-label study was conducted in a primary care setting. Adult patients with seasonal or perennial allergicrhinitis rated nocturnal rhinitis-related quality of life using the NRQLQ and sleep disturbances using the Pittsburgh Sleep QualityIndex (PSQI) at baseline and after 3 weeks of treatment with triamcinolone acetonide aqueous nasal spray (TAA AQ), 220   g/d.Changes from baseline in overall and individual domain scores for both the NRQLQ and PSQI were evaluated using  t   tests for  paired differences. Results:  The majority of the patients (N  651) were female (58%), were white (85%), and shared a bed with a partner (63%).Mean    SD patient age was 45.7    15.5 years. TAA AQ treatment was associated with significant improvements in overall NRQLQ score (mean    SD change,   1.5    1.3;  P     .001) and in individual domain scores (  P     .001 for sleep problems,symptoms during sleep, symptoms upon waking in morning, and practical problems). Similarly, overall and individual PSQIdomain scores were statistically significantly improved (  P   .001). There were strong correlations between NRQLQ and PSQIscores (all comparisons  P   .001). Conclusions:  Treatment with TAA AQ for 3 weeks resulted in statistically significant improvements in nocturnal rhinitis-related quality of life and sleep quality in allergic rhinitis patients treated in a primary care setting.  Ann Allergy Asthma Immunol.  2004;92:255–261. INTRODUCTION Allergic rhinitis is one of the top 10 reasons patients visit a primary care clinic. 1 Allergic rhinitis symptoms are associ-ated with decrements in physical, social, psychologic, andcognitive functions. 2 The burden of disease motivates patientsto seek medical help, and the goal of treatment is to improvethe patient’s health-related quality of life (HRQL). HRQL has been defined as the functional effects of an illness and itsconsequent therapy as perceived by the patient. 3,4 The in-creasing relevance of HRQL outcomes in allergic rhinitis isapparent in the recently published  Allergic Rhinitis and Its Impact on Asthma  guidelines. 1 In the past, allergic rhinitiswas classified based on the extent of nasal or ocular symp-toms; Allergic Rhinitis and Its Impact on Asthma guidelines propose that classification be based on the extent to whichsymptoms affect daily life. 1,4  Notably, sleep disturbance is acriterion for classification of allergic rhinitis; “mild” allergicrhinitis is not associated with sleep abnormalities, whereassleep disturbance is a feature of “moderate/severe” disease. 5 The exact mechanisms by which allergic rhinitis interfereswith sleep are not fully understood. Nasal congestion, whichtends to peak during the night and in the early morning, isthought to be the chief cause of rhinitis-related sleep prob-lems. 6 People with frequent nighttime rhinitis symptoms aremore likely to report habitual snoring, chronic excessivedaytime sleepiness, or chronic nonrestorative sleep than thosewho rarely or never experienced symptoms. 7 Experimentally produced nasal congestion is associated with sleep-disordered breathing events that included apnea, hypopnea, and snoring. 7 Craig et al 8 showed that nasal obstruction can lead to markedinterruption of the sleep cycle with increased microarousals.Sequelae of fragmented sleep, including fatigue, daytimesomnolence,andimpairedmood,candetractfromqualityoflife.A single night of fragmented sleep can compromise daytimewakefulness, mood, and alertness. 9,10 Serious consequences in-clude increased risk of accidents and poor performance. 8 With increased interest in HRQL, the number of validatedinstruments to evaluate the effects of disease or interventionon functional status has also increased. Instruments may begeneric or disease-specific. Generic instruments measure * Eastern Vascular Associates, Denville, New Jersey.† Aventis Pharmaceuticals Inc, Bridgewater, New Jersey.This study was supported by a research grant from Aventis Pharmaceuticals.Received for publication June 14, 2003.Accepted for publication in revised form September 29, 2003.VOLUME 92, FEBRUARY, 2004 255  general health status and allow comparison of the burden of illness among different diseases. They are broad-based andcomprehensive; however, generic instruments may not beresponsive enough to detect small but clinically meaningfulchanges in HRQL in a given disease state. 2 In contrast,disease-specific instruments target a specific disorder andmay be tailored to a particular patient population or to spe-cific problems associated with the condition under study. 11 For example, the Rhinoconjunctivitis Quality of Life Ques-tionnaire 12 (RQLQ) has been adapted for use in adolescents(Adol-RQLQ 13 ) and children (PRQLQ 14 ), shortened (theMini-RQLQ 15 ), and modified to measure only rhinitis effects(eye symptoms evaluation was removed). 16 Because the severity of allergic rhinitis symptoms is more pronounced at night and during early morning for some patients, there was concern that nocturnal rhinitis-relatedimpairments to HRQL might differ from problems associatedwith daytime allergy symptoms. Therefore, Juniper et al 6 developed the adult Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ). In the process, these investi-gators found that the functional problems most troublesometo patients with nocturnal allergic rhinitis were indeed distinctand could not fully or accurately be evaluated using existingdisease-specific instruments, including the RQLQ. 6 Triamcinolone acetonide aqueous nasal spray (TAA AQ; Nasacort AQ, Aventis Pharmaceuticals, Bridgewater, NJ) has been shown to improve symptom scores and HRQL (usingthe RQLQ) in patients with seasonal allergic rhinitis. 17–19 Theobjective of this Quality of Sleep in Allergic Rhinitis studywas to evaluate patient-reported nocturnal rhinitis-relatedquality of life using the NRQLQ in patients presenting withallergic (seasonal or perennial) rhinitis symptoms and treatedfor 3 weeks with TAA AQ, 220   g/d, in a primary caresetting. Effects of TAA AQ treatment on sleep disturbancewere also evaluated using the generic Pittsburgh Sleep Qual-ity Index (PSQI). 20 METHODS  Patients Male and female patients 18 years of age and older, with a2-year or longer history of allergic rhinitis (seasonal or pe-rennial), whose allergic rhinitis symptoms were sufficientlytroublesome to require intranasal corticosteroid treatment atstudy entry (visit 1) were eligible to participate. Patientscould not be using an intranasal corticosteroid within 1 monthof visit 1. Other exclusion criteria included pregnancy or lactation; hypersensitivity to glucocorticosteroids use of sys-temic steroids within 8 weeks of visit 1; unstable or severeasthma (patients with mild-to-moderate asthma well con-trolled by   2 - agonists, with or without low- to medium-doseinhaled corticosteroids, were eligible to participate providedthe inhaled corticosteroid dose was constant for at least 2months before study entry and was constant throughout thestudy period); clinically relevant cardiovascular, hepatic, neu-rologic, endocrine, or other major systemic disease; and his-tory of drug or alcohol abuse.Informed consent was signed by each patient before par-ticipating in the study. All investigators agreed to complywith the appropriate institutional review board and code of federal regulations (CFR.21). Study Design Patient-reported outcomes . This multicenter, open-labelstudy was conducted between March and October 2002 in primary care clinical practices across the United States. Eli-gible patients completed the NRQLQ (Table 1) and PSQI(described below) at visit 1 (baseline) and visit 2 (after 21  3 days of treatment with TAA AQ, 220   g/d, 2 sprays per nostril, 55   g per spray). A population sample size of ap- proximately 600 patients was estimated to provide a 95%confidence interval of 0.17 in mean change from baselineoverall NRQLQ score, when the SD was estimated to be 1.06.This sample size also provided high precision of change from baseline PSQI score (95% confidence interval, length of 0.6,assuming an SD of 3.75).  Nocturnal RQLQ (NRQLQ) . The NRQLQ 6 is a disease-specific quality-of-life questionnaire created to measure thefunctional problems most troublesome to patients with noc-turnal allergic rhinoconjunctivitis. The NRQLQ comprises 16items in 4 domains (Table 1). Patients are asked to recall their  Table 1. Nocturnal Rhinoconjunctivitis Related Quality-of-LifeQuestionnaire* Domain Questions Problems with sleep Difficulty getting to sleepUnable to get a good night’s sleep orwake up during the nightRestless (tossing and turning)Having to get up because of stuffynose or to blow noseSymptoms during Nasal congestion or stuffy nosesleep Sinus pressure or painRunny nosePostnasal drip (drainage down back ofnose or throat)HeadacheSymptoms on waking Feel tired and unrefreshedin the morning Nasal congestion or stuffy noseCongestion in sinusesTakes time to clear nighttime drainageafter waking upPractical problems(during wakinghours)Having to avoid symptom triggers (suchas dust, cigarette smoke, strongsmells, and perfumes)Need to rub nose or eyesHave to take medicationOverall All* Answers reflect experiences during the previous week; scored on a7-point 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. 256 ANNALS OF ALLERGY, ASTHMA, & IMMUNOLOGY  experiences during the previous week and to respond to eachitem on a 7-point scale (0, not troubled; 1, hardly troubled atall; 2, somewhat troubled; 3, moderately troubled; 4, quite a bit troubled; 5, very troubled; and 6, extremely troubled).  PSQI  . The PSQI 20 is an instrument designed to measuresleep disturbance over the previous month. This instrumentconsists of 19 items over 7 domains: subjective sleep quality,sleep latency, sleep duration, habitual sleep efficiency, sleepdisturbances, use of sleep medications, and daytime dysfunc-tion. An additional (nonscored) question asks whether the patient has a bed partner or roommate. Domains are scored ona 0 to 3 scale; a score of 3 indicates the negative extreme (0,not during the past month; 1,   1 time per week; 2, 1 to 2times per week; and 3, 3 or more times per week). Habitualsleep efficiency domain scores, which represent the percent-age of time spent asleep in bed, were derived from answers toquestions 1 (usual bed time), 3 (usual getting-up time), and 4(actual hours of sleep). An overall PSQI score was calculated by adding the 7 domain scores together (range: 0    nodifficulty to 21  severe difficulties in all areas). Safety Safety was assessed by adverse event reporting. Overall in-cidence, maximum severity, and relationship to treatmentwere evaluated. Statistical Analyses Means and SDs in individual domain scores and in overallscores of the NRQLQ and PSQI were measured at baseline(visit 1) and at the end of treatment (visit 2). Differences from baseline were analyzed using a paired  t   test. A priori signif-icance levels set at .05 (2-tailed) were considered significant. NRQLQ and PSQI individual domain and overall scores wereanalyzed according to sex and by sleeping arrangements(“partner in same bed/room” vs “no partner or partner in other room”).Additionally, we measured the frequency distribution of  proportions of patients with mean NRQLQ responses be-tween 0 and 2 (“not troubled” to “somewhat troubled”) andthose with mean responses between 3 and 6 (“moderatelytroubled” to “extremely troubled”) at baseline and at the endof the study. Correlations between mean changes in NRQLQand PSQI scores were compared using Pearson correlationcoefficient analysis. RESULTS  Patient Demographics A total of 651 patients from 144 sites were enrolled. Of them,590 (91%) completed the study. Thirteen patients (2%) discon-tinued the study due to an adverse event (5 for headache; 2 for nausea;and1eachfornasalburning,eyeburning,nasaldryness,insomnia, sinusitis and congestion, nose bleed). Three patients(0.5%) discontinued due to major protocol violations, 34 (5.2%)were lost to follow-up, and 11 (1.7%) discontinued for other reasons. Table 2 shows patient characteristics at baseline. Inves-tigators questioned patients about compliance at study end;however, compliance data were not recorded.  Patient-Reported Outcomes NRQLQ . Statistically significant improvements from baselinein overall NRQLQ and PSQI scores are illustrated in Figure1. Individual NRQLQ domain scores are presented in Figure2; all NRQLQ domain scores were statistically improved atstudy end vs baseline (  P     .001 for all comparisons). Themean change in overall NRQLQ score,   1.5 (   1.3), wasstatistically significant and clinically meaningful. In eachdomain, the percentage of patients reporting either “not trou- bled” or “hardly troubled at all” increased for each includeditem between the baseline visit and the end of the 3-week treatment period. Of the 16 items in the NRQLQ, 7 items in3 domains are specifically related to nasal or sinus symptomseverity (Table 1). Proportions of patients reporting milder impairment related to nasal symptoms markedly increasedfrom baseline to end of treatment, and conversely, propor-tions of those with more severe impairment due to nasalsymptoms markedly decreased between baseline and end of treatment (Figs 3 and 4).Greater improvements were observed in all domains for female vs male subjects; however, mean changes from base-line at the end of the study in male and female responsesshowed similar statistically significant improvements (  P    .001) overall and in each individual domain. When data were Table 2. Patient Characteristics at Baseline Characteristic* No. (%) of patients(N  651)† SexMale 271 (41.6)Female 379 (58.2)Not reported 1 (0.2) Age, yMean (   SD) 45.7 (15.5)Range 4–89Not reported or reported as “0” 4 (0.6)RaceWhite 553 (84.9)Black 43 (6.6)Hispanic 28 (4.3) Asian 19 (2.9)Other 6 (0.9)Not reported 2 (0.3)Years with allergic rhinitisMean (   SD) 10.6 (10.7)Range 1–63Bed partner/roommate statusPartner in same bed 406 (62.7)No bed partner or roommate 171 (26.4)Partner/roommate in other room 51 (7.9)Partner in same room, but not in same bed 20 (3.1)* May not have been reported for 1 or more patients.† Data are number (%) of patients with each response of the 651patients with valid data unless otherwise indicated. VOLUME 92, FEBRUARY, 2004 257  stratified by bed partner status, changes in overall scores didnot vary by sleeping arrangements. Furthermore, all individ-ual NRQLQ domain scores and the overall score in bothstrata were significantly improved after TAA AQ treatmentcompared with baseline (  P   .001).  PSQI  . Overall and individual PSQI domain scores weresignificantly improved after 3 weeks of TAA AQ treatment(  P     .001 for all comparisons; Figs 1 and 5, respectively).Habitual sleep efficiency scores showed the percentage of time asleep in bed improved by end of study relative to Figure 1. Overall Nocturnal Rhinoconjunctivitis Qual-ity of Life Questionnaire (NRQLQ) and Pittsburgh SleepQuality Index (PSQI) scores at baseline and after 3 weeksof triamcinolone acetonide aqueous nasal spray treat-ment.Figure 2. Individual Nocturnal RhinoconjunctivitisQuality of Life Questionnaire (NRQLQ) domainscores at baseline and after 3 weeks of triamcinoloneacetonide aqueous nasal spray treatment.Figure 3. Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire responses to items directly related tonasal or sinus symptoms.258 ANNALS OF ALLERGY, ASTHMA, & IMMUNOLOGY   baseline; the proportion of patients who reported they slept85% or greater of time spent in bed rose from approximatelyhalf (49.2%) to three quarters (72.9%) after treatment.Slightly greater improvements in individual domains werereported by female patients (except subjective sleep qualityand sleep disturbances); however, similar statistically signif-icant improvements (  P     .001) were noted overall and inevery PSQI domain. Patients with no partner in the bedroomshowed greater improvement in all 7 domains compared with patients who shared a bedroom with another person, but allimprovements in both strata were statistically significantcompared with baseline (  P   .001).Correlations between mean changes in NRQLQ and PSQIscores were in the expected direction; indicated a strong,linear, positive relationship; and were statistically significant(  P   .001). Safety Of 88 patients (14%) who reported 1 or more adverse eventsduring the study (total events, N  146), 31 experienced anadverse event considered possibly related to study medica-tion. Headache was the most frequently reported adverseevent (Table 3) and was the most frequent event considered possibly related to treatment (7 of 13 events). Two patientsexperienced a serious adverse event during the study (bron- Figure 4. Nocturnal Rhinoconjunctivitis Qualityof Life Questionnaire responses to items directlyrelated to nasal or sinus symptoms (continued).Figure 5. Individual Pittsburgh Sleep QualityIndex (PSQI) domain scores at baseline and after 3weeks of triamcinolone acetonide aqueous nasalspray treatment. Table 3. Most Frequently Reported Adverse Events (   0.5% ofPatients, Any Causality) Event No. (%) of patients(N  651) Total adverse events 88 (14.0)Headache 13 (2.0)Sinusitis 7 (1.1)Upper respiratory tract infection 3 (0.5)Nausea 3 (0.5)Insomnia 3 (0.5)Bronchitis 3 (0.5)Nose bleed 5 (0.8) VOLUME 92, FEBRUARY, 2004 259
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