Desloratadine in the Treatment of Seasonal Allergic Rhinitis

Desloratadine in the Treatment ofSeasonal Allergic RhinitisResults of a Large Observational Study

Claus Bachert,1 Christian J. Virchow Jr2 and Astrid Plenker3

1 Department of ENT, University of Ghent, Ghent, Belgium2 Department of Pneumology, University Medical Clinic, Rostock, Germany3 Essex Pharma, Munich, Germany

Abstract Objective: To assess the efficacy and safety of desloratadine in the treatment ofseasonal allergic rhinitis (SAR) in the clinical setting.

Design and Setting: The postmarketing surveillance study was performed in Ger-many in 47 953 outpatients requiring treatment of SAR between February andOctober 2001.

Results: The mean duration of desloratadine treatment was 38.4 days and com-pliance was rated as good/excellent in 98% of cases. Mean nasal, ocular, asthma,dermal and total symptom sum scores were reduced significantly duringdesloratadine treatment compared with baseline (p = 0.0001). Interference withdaily activity and sleep disturbance decreased markedly during desloratadinetherapy. Of patients with SAR and asthma symptoms at baseline, 50.7% alsoreduced their asthma medication during desloratadine treatment. The global ef-ficacy of desloratadine was rated as good/excellent by 91.2% of patients and92.6% of physicians. Global safety/tolerability was rated as good/excellent by98.9% of physicians and 98.5% of patients and the adverse event rate was verylow (0.44%). Onset of symptom relief following desloratadine was rated as fasterthan previous treatment by 64.1% of physicians and 65.7% of patients.

Conclusions: This study supports the evidence from placebo-controlled trials thatdesloratadine is an effective and well tolerated treatment for SAR symptoms,including nasal congestion. Desloratadine provided significant relief of otherassociated problems, including related asthma and dermal symptoms.

ORIGINAL RESEARCH ARTICLE Clin Drug Invest 2002; 22 Suppl. 2: 43-521173-2563/02/0002-0043/$25.00/0

© Adis International Limited. All rights reserved.

Introduction

Seasonal allergic rhinitis (SAR) is a commoncondition with bothersome symptoms, which havebeen shown to interfere with daytime functioningand sleep.[1,2] SAR can also significantly affectlearning in school-aged children.[3] Nasal conges-tion, which is often poorly treated by antihistaminetherapy,[4] is associated with disordered breathing

during sleep,[5] which can impair general healthmeasures.[6] Apart from these effects, SAR is asso-ciated with other allergic comorbidities,[7] the mostimportant of which is asthma.[8] These diseases,which are linked by common genetic, environmen-tal and pathophysiological factors, are mediated atthe tissue level by similar effector cells and medi-ators.[9] Cells, such as mast cells, basophils andeosinophils, along with the cytokines interleukin

(IL)-4, IL-13 and IL-5 and chemokines, combineto orchestrate systemic allergic inflammatory re-sponses.[10] Although the end-organ responses inthe nose, lung and skin that occur as a result ofsystemic allergic inflammation differ in theirsymptomatology, they share the early- and late(chronic)-phase allergic response patterns. Hence,in contrast to topical local treatment of SAR,pharmacological inhibition of systemically avail-able allergic mediators may affect manifestationsof allergic comorbidities, such as allergic inflam-mation of the lower airways and skin.

Desloratadine is a new nonsedating H1 receptorantagonist[11] that provides rapid and enduringcontrol of symptoms of SAR[12] and chronic idio-pathic urticaria (CIU).[13] Clinical studies in pa-tients with SAR have shown that desloratadine ishighly effective at decreasing nasal and non-nasalsymptoms.[14] In particular, desloratadine is effec-tive in reducing the obstructed nasal airflow asso-ciated with nasal congestion,[15,16] which has beenreproduced in the setting of controlled grass pollenexposure.[17] Pharmacokinetic studies of deslorata-dine have determined a half-life of 27 hours,[18]

which translates into a 24-hour duration of actionas has been observed in clinical studies, in whichsignificant reductions in SAR symptoms weremaintained at trough plasma levels during once-daily dose administration.

Postmarketing studies of newly approved med-ications are growing in importance, particularly interms of identifying adverse events that were notapparent during controlled clinical trials. Phase IIIstudies are mandated by regulatory authorities as anecessary step before drug approval, but becauseof their rigorous design usually involve only hun-dreds of patients with well defined physical anddisease characteristics. As such, these studies can-not account for effects on drug efficacy and safetydue to inaccurate dosing and the consumption ofconcomitant medications encountered duringtreatment of millions of patients once the drug ison the market. Serious adverse events may not benoted until the drug is used by a broad group ofpatients in the normal clinical setting. There have

been a number of high-profile drug withdrawals inthe last 5 years, including cerivastatin,[19] troglita-zone,[20] cisapride,[20] mibefradil[21] and terfena-dine.[22] As these drugs were withdrawn for safetyreasons that became apparent only after they wereon the market, greater emphasis is now beingplaced on identifying potentially hazardous eventsby increased use of postmarketing surveillanceand reporting techniques.[23] In parallel with safetyissues, postmarketing surveillance studies are anopportunity to assess whether a drug’s efficacy asreported in tightly controlled phase III studiestranslates into meaningful improvements in dis-ease severity as reported by physicians and pa-tients. Under German drug law, postmarketingsurveillance of new medicinal products is per-formed as recommended by the Federal Institutefor Drugs and Medical Devices (Bundesinstitut fürArzneimittel und Medizinprodukte). Deslorata-dine has been available in Germany for the treat-ment of SAR since January 2001. We conductedan open-label observational study to examine theefficacy and safety of desloratadine in a largepatient population in the regular clinical setting.

Methods

This was an observational, postmarketing sur-veillance study conducted in Germany betweenFebruary and October 2001. The study was per-formed in the clinical practice of general practi-tioners and allergists. Patients attending their phy-sician with symptoms of SAR that were expectedto last for the treatment period were eligible forenrolment. Exclusion criteria were sensitivity, al-lergy or previous adverse reaction to desloratadineor its excipients. Pregnant or lactating women werealso excluded from enrolment and any subsequentpregnancy in a patient or the partner of a patientwas recorded separately. Eligible patients under-took two study visits: visit 1 at enrolment and visit2 at the end of desloratadine treatment. At eachvisit both patients and physicians completed studyquestionnaire forms.

44 Bachert et al.

© Adis International Limited. All rights reserved. Clin Drug Invest 2002; 22 Suppl. 2

Visit 1 Assessments

At visit 1 the patient’s medical history and thecharacteristics of any clinically significant non-allergic diseases were recorded together withdemographic data (age, sex, weight and height) onthe study questionnaire form. Furthermore, thediagnosis and duration of seasonal allergic rhinitisas well as other antihistamine treatment duringthis allergy season were recorded. Patients ratedthe efficacy of other antihistamine therapy on a4-point scale as either excellent (1), good (2), mod-erate (3) or poor (4).

Symptom Assessment

At the start (visit 1) and the end of therapy (visit2), patients rated the severity of their nasal, ocular,asthma and dermal symptoms:• nasal symptoms: nasal congestion, runny nose,

sneezing/itching• ocular symptoms: watery eyes, burning/itching,

redness• asthma symptoms: wheeze, breathlessness,

chest tightness, cough• dermal symptoms: itching, hives/pustules, dry-

ness.The severities of individual symptoms were

scored on a 4-point scale as none (0), mild (1),moderate (2) and severe (3). The scores wereadded together under each heading. A total sumscore was calculated as the sum of all four organ-specific scores (nasal, ocular, asthma and dermal).

At visit 1 and visit 2, patients scored the degreeof sleep disturbance [after 12am (midnight)] andinterference with daily activity [after 12pm(noon)] caused by their illness. The severities ofsleep disturbance and interference with dailyactivities were scored on a 4-point scale as none(0), mild (1), moderate (2) and severe (3).

Visit 2 Assessments

Both physicians and patients gave separateglobal assessments of desloratadine treatment atvisit 2. Both also assessed the onset of symptomrelief compared with previous antihistamine ther-

apy as quicker, equivalent or slower. In addition,physicians rated the global efficacy, tolerabilityand compliance with the prescribed desloratadinemedication separately on a 4-point scale: excellent(1), good (2), moderate (3) or poor (4); patientswere asked to rate only the global efficacy andtolerability of desloratadine. Patients and physi-cians noted whether other medications were re-quired for the treatment of the allergic symptomsduring desloratadine treatment. Patients withasthma were questioned whether their dose of anti-asthmatic medication was reduced during deslora-tadine treatment (‘yes’ or ‘no’).

Adverse Events

The prescribing doctor recorded all adverseevents that were reported during desloratadinetreatment. Any adverse event that was classified asserious and was reported during or up to 30 daysafter the study was documented on a specific reportform. Pregnancy occurring in a patient or partnerof a patient was documented similarly to that of aserious adverse event.

Patients provided informed written consent tothe study, which was performed according to theDeclaration of Helsinki and the legal obligationsunder German national legal statutes.

Statistical Analysis

Data entered on case report forms were codedinto a database and assessed for inconsistencies byuse of an electronic plausibility checking system.Coding and data analyses were performed inde-pendently by DABIO, Höhenkirchen, Germany.The number of patients with valid data for eachstudy parameter was calculated from the case re-port forms. For continuous data, such as symptomscores, the number of valid entries, the mean, thestandard deviation and minimum and maximumvalues were calculated. With respect to categoricaldata, frequencies and percentages were calculated.

The primary efficacy parameter was the changeat visit 2 from visit 1 in the total sum score. Sec-ondary efficacy parameters were the changes in theseverity of the nasal, ocular, asthma and dermal

Desloratadine in the Treatment of SAR 45


sum scores and the individual symptom scores atthe end of treatment. Other secondary parametersincluded the global assessments of efficacy andtolerability and the degree of disease-related dis-turbance of sleep and daytime functioning. Sumscores were evaluated descriptively at visit 1 andvisit 2 and were analysed using the Wilcoxonsigned-rank test for interindividual differences.

Results

Demographics

A total of 47 953 patients took part in this ob-servational study. All results displayed are basedon numbers of patients with valid data recorded ontheir case report form for each study parameter.Demographic data are displayed in table I. In sum-mary, 42% of patients were male, 58% were femaleand the mean age was 38.8 years. The mean dura-tion of desloratadine treatment during the studywas 38.4 (range 1 to 232) days.

Efficacy

Total SymptomsThe main efficacy parameter of this observa-

tional study was the change in mean total sum scoreduring treatment with desloratadine. Valid datawere available for 47 872 patients for this param-eter. Mean total sum score fell significantly duringdesloratadine treatment from 12.43 points (95% CI12.38 to 12.48) to 2.99 points (95% CI 2.96 to 3.02)at the end of treatment (p = 0.0001) [figure 1].

Nasal SymptomsThe mean nasal sum score fell significantly dur-

ing treatment from 5.45 (95% CI 5.43 to 5.47) to1.41 (95% CI 1.40 to 1.43) [n = 47 576; p =0.0001]. Prior to treatment with desloratadine67.2% of patients rated nasal congestion as mod-erate or severe. This improved markedly by the endof treatment, when only 6.2% of patients had mod-erate or severe nasal congestion, while the percent-age of patients who reported no nasal congestionrose from 13.6% before desloratadine treatmentto 55.1% at the end of the treatment phase (p =0.0001) [figure 2]. A total of 71.6% of patients re-ported moderate/severe rhinorrhoea before treat-ment, which fell to 5.2% after desloratadine. Sim-ilarly, the rate of moderate or severe sneezing/itching before desloratadine (74.7%) decreased toonly 5.2% by the end of treatment (figure 2).

Ocular SymptomsDesloratadine treatment reduced the mean ocu-

lar sum score significantly from 4.34 (95% CI 4.32to 4.36) to 0.84 (95% CI 0.83 to 0.86) [n = 47 451;p = 0.0001] (figure 3). The individual componentsof the ocular sum score also decreased duringdesloratadine treatment. At baseline 52.6, 58.1 and43.6% of patients reported moderate/severe wateryeyes, burning/itching eyes and redness, respec-tively. These percentages fell to 3.6, 4.1 and 2.7%by the end of desloratadine treatment.

0

3

6

9

12

15

18

*

Tota

l sym

ptom

sco

re

PretreatmentPost-treatment

Fig. 1. Total symptom sum score (mean ± standard deviation)for patients before and after treatment with desloratadine. Totalsymptom sum score was calculated by summing the nasal, oc-ular, asthma and dermal sum scores; the total sum score couldrange from 1 to 39 points. * p = 0.0001.

Table I. Demographic data for study population based on visit 1case report form responses

Mean (SD) No. of valid patients

Age (y) 38.8 (15.3) 44 255

Weight (kg) 71.2 (13.4) 46 966

Height (cm) 171 (9.0) 46 966

Body mass index 24.2 (3.7) 46 966

Duration of seasonalallergic rhinitis (mo)

88.5 (80.1) 40 997

Sexmale 20 030 (42.2%)

female 27 452 (57.8%)

SD = standard deviation.

46 Bachert et al.


Asthma SymptomsA total of 46 962 patients recorded viable data

on asthma symptom severity. The mean asthmasum score for the group overall at baseline was lowat 1.53 (95% CI 1.51 to 1.55), but fell significantlyfollowing desloratadine treatment to 0.43 (95% CI0.42 to 0.44) [p = 0.0001].

Since 27 443 patients recorded no asthmasymptom at baseline, a subgroup analysis was per-formed on the 19 519 patients who recorded atleast one asthma symptom at baseline (wheeze,breathlessness, chest tightness or cough). Themean asthma sum score in this subgroup fell from3.68 (95% CI 3.64 to 3.71) to 1.01 (95% CI 0.99to 1.03) [p = 0.0001] following desloratadinetreatment.

Individual asthma symptoms for the overall pa-tient population are shown in table II; the majorityhad no asthma symptom at baseline and low per-centages had moderate/severe symptoms. Thiscontrasts with the findings for the subgroup thatreported asthma symptoms at baseline (table II).Wheezing, breathlessness, chest tightness andcough were rated as moderate/severe at baseline in23.9, 25, 18.2 and 35.4% of these patients, respec-tively. After desloratadine treatment the percent-ages of patients experiencing moderate/severewheeze, breathlessness, chest tightness and coughhad fallen to 2.9, 3.1, 2.2 and 3.8%.

As expected, the mean total symptom sum scorefor this asthma symptom subgroup was higher thanfor the population overall (15.36 vs 12.43). How-ever, the effect of desloratadine treatment on thetotal symptom score was higher in the asthmasubgroup, which recorded a mean 11.41-pointdecrease during treatment, compared with a dropof 9.45 points for the general study population(p = 0.0001).

Asthma Medication RequirementsOf the 47 953 patients enrolled, 8743 recorded

data on changes in asthma medication irrespectiveof reported symptoms of asthma. A total of 46%

0

10

20

30

40

50

60

70

Pat

ient

s (%

)

Nasalcongestion

Rhinorrhoea Itching/sneezing

Nasalcongestion

Rhinorrhoea Itching/sneezing

NoneMildModerateSevere

Baseline Post-treatment

Fig. 2. Individual nasal symptom severities as rated by patients at baseline and after treatment with desloratadine.

0

3

6

9

*Ocu

lar

sum

sco

re


Fig. 3. Ocular sum score (mean ± standard deviation) for pa-tients before and after treatment with desloratadine. * p =0.0001.



reported a reduction in asthma medication duringthe study, while 54% reported no reduction.

Of the subgroup of 19 519 patients who had re-ported at least one asthma symptom at baseline,information was available on 7021 regarding anyreductions in asthma medication. Of these, 3557(50.7%) reported a reduction in asthma medicationrequirements, while 3464 (49.3%) reported none.

Dermal SymptomsThe mean dermal sum score at baseline for the

overall patient population was low, at 1.24 points(95% CI 1.22 to 1.26), and fell significantly withdesloratadine treatment to 0.34 (95% CI 0.33 to0.35) [n = 47005; p = 0.0001]. A subgroup analy-sis was performed on patients who reported at leastone dermal symptom at baseline [18 468 of 47 005(39.3%) evaluable patients]. In this dermal sub-group, the mean dermal sum score was 3.16 (95%CI 3.13 to 3.19), which decreased significantly to0.84 (95% CI 0.82 to 0.86) with desloratadinetreatment (p = 0.0001) [figure 4].

Global Assessments

Both patients and physicians rated the globalefficacy of desloratadine treatment on a 4-pointscale (1 = poor to 4 = excellent). Patients’ globalassessment rated the efficacy of desloratadine asexcellent, good and moderate in 56.2, 35.0 and

5.7% of cases, respectively. Physicians’ rating of theefficacy of desloratadine was similar: 54.1% (ex-cellent), 38.5% (good) and 5.4% (moderate). Only2.1% of patients and 3.1% of physicians rated theglobal efficacy of desloratadine as poor (figure 5).

Desloratadine was well tolerated during thestudy. The global assessment of tolerability/safetydemonstrated that patients rated desloratadine asexcellent, good and moderate in 76.4, 22.1 and0.9% of cases, respectively. Physicians rated thetolerability of desloratadine as excellent in 79.2%of cases, good in 19.7% and moderate in 0.6%.Fewer than 1% of patients (0.6%) and physicians

Table II. Patient-rated asthma symptom severities at the start and end of treatment with desloratadine in a subgroup of patients with at leastone asthma symptom at baseline

None Mild Moderate Severe

no. % no. % no. % no. %

WheezingStart 7737 41.2 6554 34.9 3797 20.2 697 3.7

End 14 684 78.2 3565 19.0 487 2.6 49 0.3

BreathlessnessStart 7143 37.9 7009 37.2 3983 21.1 731 3.9

End 14 773 78.3 3512 18.6 503 2.7 78 0.4

Chest tightnessStart 9203 49.0 6167 32.8 2939 15.7 468 2.5

End 16 127 85.9 2245 12.0 353 1.9 52 0.3

CoughStart 2701 14.3 9490 50.3 5575 29.5 1114 5.9

End 12 775 67.7 5398 28.6 621 3.3 86 0.5

0

3

6

9

*

Der

mal

sum

sco

re


Fig. 4. Dermal sum score (mean ± standard deviation) beforeand after treatment with desloratadine in a subgroup of patientswith at least one dermal symptom at baseline (n = 18145). * p= 0.0001.

48 Bachert et al.


(0.4%) rated the tolerability of desloratadine aspoor.

Physicians scored the compliance of their pa-tients with desloratadine treatment separately.Compliance was excellent, good, moderate andpoor in 74.1, 23.9, 1.6 and 0.4% of cases, respec-tively.

Efficacy of Desloratadine versusPrevious Treatment

A total of 17 517 patients reported previoustreatment of their allergy symptoms with anothermedication. Of these, 35.8% received loratadine,20.3% cetirizine and 12.5% fexofenadine; 27.4%were treated with an unspecified drug and 4.1%received multiple previous medications. Whenasked to score the efficacy of previous therapy,only 4.6% rated it as excellent, 36.1% rated effi-cacy as good, 50.7% as moderate and 8.6% as poor.

A total of 28 398 patients and physicians re-corded data that compared the onset of efficacy ofdesloratadine with that of previous antiallergictreatment. Physicians reported the onset of effi-cacy of desloratadine as faster than or equal to thatof previous treatment in 64.1 and 32.8% of cases,respectively. For patients, the onset of efficacy ofdesloratadine was faster than previous therapy in65.7% and equal in 29.9% of cases. Physicians andpatients rated the onset of efficacy of desloratadine

as slower than that of previous treatment in only3.1 and 4.5% of cases, respectively.

Effect on Sleep and Daily Activities

The questionnaire included assessments by pa-tients about how their allergic symptoms interferedwith sleep (after 12am) and their daily activities(after 12pm). A total of 46 535 patients provideddata for this question. At baseline the proportionof patients reporting sleep disturbance was as fol-lows: none 35.5%, mild 30.2%, moderate 27.9%and severe 6.4%. By the end of desloratadine treat-ment the proportion of patients with no sleep dis-turbance rose to 83.1%, while mild, moderate andsevere sleep disturbance was reported by 14.4, 2.2and 0.4%, respectively.

The findings for effect of allergic symptoms ondaily activities were similar to that of effect onsleep. Data were available for 46 712 patients. Atbaseline the percentages of patients experiencingimpairment of daily activities were as follows:none 26.1%, mild 33.8%, moderate 33.4% andsevere 6.6%. Desloratadine treatment was associ-ated with a large increase in the percentage ofpatients reporting no disturbance of daily activities(79.4%), while the percentages with mild, moder-ate and severe impairment fell to 17.6, 2.6 and0.4%, respectively.

Adverse Events

A total of 287 adverse events were reported in212 patients (adverse event rate: 0.44%); 242 ad-verse events were rated as probably or possiblyrelated to desloratadine treatment. No single ad-verse event was reported at a rate greater than 0.1%in the population. The most common probable/possible treatment-related adverse events were fa-tigue (47 patients), headache (41), nausea (22), drymouth (19) and diarrhoea (6). The majority of ad-verse events were mild/moderate in nature andimproved during continued treatment with des-loratadine. One serious adverse event was reportedin a 15-year-old female patient with pre-existingGilbert’s syndrome (chronic unconjugated hyper-bilirubinaemia). The patient developed abdominal

0

20

40

60

80

100

Physician Patient

Effi

cacy

(%

)

PoorModerateGoodExcellent

Fig. 5. Global assessment of efficacy of desloratadine treatmentby physicians and patients.



pain, tachycardia, sweating and bilious vomitingwhile on desloratadine and required supportivecare in hospital but recovered completely. The ad-verse event was rated by the physician as probablydesloratadine related, but her hepatic disease mayhave had a significant effect on her symptomatol-ogy. One 36-year-old patient took desloratadinefor 20 days during her second trimester of preg-nancy. No hazardous events related to deslorata-dine treatment were noted.

Discussion

Well designed, placebo-controlled clinicalstudies have shown desloratadine to be a welltolerated and effective therapy for SAR andCIU,[12,13] with a rapid onset of action and clinicalefficacy 24 hours after administration.[14] Thisstudy was conducted to determine whether this ef-ficacy and safety profile was maintained in the set-ting of daily clinical practice. Postmarketing stud-ies are performed primarily to identify safetyissues that arise in the general population but werenot identified in regulatory placebo-controlled tri-als. Patients who do not meet the strict entry cri-teria for regulatory approval studies may be sus-ceptible to new and potentially serious adverseevents once the drug is on the market. Despite therigour and good design of phase III studies, a num-ber of high-profile market withdrawals have comeabout in recent years because of potential adverseevents in small numbers of patients.[19-22] In thecase of terfenadine, however, effects on cardiacelectrophysiology were not noted until hazardousadverse events had occurred in susceptible pa-tients.[24] Postmarketing studies can help to iden-tify such problems in the early period after a drugis launched, particularly if they include a largenumber of patients. The current study recruited 47953 patients, and the efficacy and safety profile ofdesloratadine was assessed for an average treat-ment period of 38.4 days. The design of the studyprovided for two assessments, before and at the endof treatment, and no interim assessments were per-formed. Therefore the results describe the overalleffects of desloratadine, rather than the evolution

of efficacy and safety parameters during treatment.The results are limited by their observational na-ture and the lack of placebo control, but do provideuseful information regarding patients’ and physi-cians’ experiences with desloratadine. Further-more, these data provide an insight into the spec-trum of symptoms experienced by patients withSAR.

Overall, patients treated with desloratadine ex-perienced significant reductions in nasal, ocular,asthma and dermal and total symptom sum scores.The magnitudes of these reductions were similar,with percentage decreases in symptom severity inthe range of 71.9 to 80.6%. The majority of patients(approximately 93%) rated symptoms of conges-tion, rhinorrhoea or itching/sneezing as none ormild; of these, approximately 54% had no symp-toms by the end of treatment. Desloratadine re-duced the percentage of patients reporting severenasal congestion from 21.2 to 0.9%, which sup-ports the consistent effect of desloratadine on nasalcongestion seen in placebo-controlled clinicaltrials and allergen challenge studies.[15-17] Thetreatment duration in this study was determinedindividually and desloratadine may have beenstopped when clinically relevant improvementshad occurred or when seasonal allergen exposurehad subsided. Thus, the reported clinical effects ofthis observational study are likely to exceed thosefrom controlled studies because of these differ-ences in their design.

A sizeable proportion of patients with SAR inthis study also reported symptoms that are consid-ered classically ‘asthma-like’, namely, cough,wheezing, breathlessness and chest tightness. Ap-proximately 19 000 patients had at least one asthmasymptom at baseline, indicating that asthma-typesymptoms were common in this population. Sincea formal diagnosis of asthma was not establishedwith objective spirometry and reversibility, con-clusions regarding the effect of desloratadine onclassically defined asthma are limited. However,8743 patients answered the question ‘For asthmapatients: Could the dosage of asthma medicationsbe reduced?’ These patients, 46% of whom an-

50 Bachert et al.


swered ‘yes’, considered themselves to haveasthma by simply answering the question. If oneexamines a subgroup of these patients who had atleast one asthma symptom at baseline (n = 7021),50.7% answered ‘yes’ to this question. It should benoted that the design of the trial did not includecollection of information on the precise type ofasthma medications taken by patients. These find-ings are interesting for a number of reasons.Firstly, a sizeable number of SAR patients had atleast one asthma-type symptom at baseline, whichindicates that asthma-type symptoms may be com-mon in patients with SAR. Also, patients withasthma symptoms at baseline had much greatertotal SAR symptom sum scores (>3 points) thanpatients without. It may be that a subset of SARpatients experience coexisting chest/asthma symp-toms as a major part of their seasonal allergy symp-tom complex. Placebo-controlled studies of des-loratadine[25] and other antihistamines[26,27] inpatients with SAR and coexisting mild asthmahave shown significant reductions in asthmasymptoms. Whether this efficacy is due to a directeffect on the lower airways, an improvement inupper airway (nasal) function or other mechanismsremains to be determined.

The results of observational studies need to beinterpreted with caution and in context. Therandomised, placebo-controlled trial is the goldstandard of research both for physicians and forregulatory authorities. Observational studies lacka placebo control arm and must be viewed in thecontext of how the results obtained compare withthose of placebo-controlled trials. In the currentstudy, the findings relating to nasal congestionsymptoms and asthma symptoms are of particularinterest. Analysis of placebo-controlled trials ofSAR patients treated with desloratadine has shownconsistent reduction of nasal congestion symp-toms.[4,15] Confirmatory evidence of its effect onnasal congestion has also been provided from aplacebo-controlled objective study in which nasalairflow in response to allergen exposure was main-tained by desloratadine.[17] The high frequencyof reported asthma symptoms and the reduction

in the severity of these asthma symptoms duringdesloratadine treatment in this study provide sup-portive evidence for the efficacy of desloratadinein patients with SAR and seasonal asthma.[25] Inthe light of the recommendations of the WorldHealth Organization’s Allergic Rhinitis and itsImpact on Asthma (ARIA) document,[28] the re-sults of this study indicate that closer questioningof rhinitis patients about asthma symptoms mayreveal asthma-type symptoms (e.g. cough, wheeze)in a sizeable proportion of patients. Whether thesepatients actually have classical asthma, as definedby objective spirometry, is not answered by thisobservational study because of methodologicallimitations.

In conclusion, desloratadine was effective andwell tolerated when used in the treatment of SARsymptoms in everyday clinical practice in a largepopulation of patients in Germany. Desloratadinewas associated with improvement in nasal conges-tion and SAR symptoms, and the effect of allergicsymptoms on sleep and daily activity was reduced.Desloratadine also reduced reported asthma-typesymptoms and asthma medication use in a sub-group of patients. The findings of this largepostmarketing study, while limited by method-ological constraints, provide confirmation of theefficacy and tolerability of desloratadine reportedin placebo-controlled trials.

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Correspondence and offprints: Dr Claus Bachert, Dep. NKO,University of Ghent, De Pintelaan 185, Ghent, Belgium.E-mail: [email protected]

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Desloratadine in the Treatment of Seasonal Allergic Rhinitis