Evidence Table 3Perennial allergic rhinitis trials in adults

Author
Year
Country
Study
Design
Setting
Population
Eligibility criteria
Exclusion criteriaAge
Gender
Ethnicity
InterventionsAllowed other medications/interventionsMethod of outcome assessment and timing of assessmentNumber withdrawn/lost to follow up/analyzedResults
Bachert 2004
Persistant Allergic Rhinitis
Trial name
XPERT Multinational -Belgium, France, Germany, Italy, and Spain Canonica 2006 Klimek 2007
DB RCT MulticenterPER symptoms (i.e. rhinitis 4 days a week for 4 or more consecutive weeks) and sensitized to both house mites and pollenPregnant patients, nursing mothers, and women of childbearing age not using a medically accepted method of contraception; ear, nose, or throat or eye infection during the 2 weeks preceding the initial visit, and patients with asthma requiring daily treatment with other than an inhaled β-agonist as needed; atopic dermatitis or urticaria requiring antihistamine or corticosteroid treatment; an associated ear, nose, or throat disease such as vasomotor rhinitis or nasal polyps; other clinically significant diseases such as glaucoma or cardiovascular or hepatic diseases; or any condition likely to disturb absorption, distribution, metabolism, or excretion of the investigational drug.Mean age 30.3
43.7% male
Ethnicity NR
Levocetirizine 5mg or placebo onceNasal or ocular cromolyn and prednisoloneSymptoms, HRQOL and health status via electronic patient diary131/1/551Most data in graphs.
Levocetirizine vs. placebo in HRQOL (P < 0.001 for all RQLQ domains and overall scores) and health status (P < or = 0.004 for SF-36 physical and mental summary scores; P < 0.05 for all SF-36 scales)
Improvement of Levocetirizine over placebo
Overall RQLQ 36.4%, activities 38.5%, emotions 37.4%, eye symptoms 40.2%, nasal symptoms 40.3% and sleep 40.8%
Mean changes in SF-36 (placebo minus Levocetirizine)
Role-physical −9.92
Role-emotional −7.16
at 4 weeks mean T5SS levocetirizine versus placebo (−3.54 vs −2.40), which equates to an adjusted mean difference of 1.14 (P < .001)
effect of treatment on 5 RQLQ activities
Doing your house work:
change from baseline for placebo at 6 months mean, SE: −1.87(0.18)
change from baseline for levoceterizine at 6 months: −2.57 (0.18), difference vs placebo 95% CI 0.70 [0.23; 1.16), p=0.003
Playing sport:
placebo change from baseline at 6 months: −1.73 (0.20)
levoceterizine change from baseline at 6 months: −2.23(0.23), difference vs placebo 95% CI 0.50(−0.07; 1.06), p=NS
Driving
placebo change from baseline at 6 months −2.49 (0.24)
levoceterizine change from baseline at 6 months -−2.82 (0.21), difference vs placebo 95% CI 0.34[−0.25; 0.93), p=NS
Outdoor activities
placebo change from baseline at 6 months −2.20(0.22)
levoceterizine change from baseline at 6 months −2.96(0.22), difference vs placebo 0.76 (0.17; 1.35), p=0.011
Carrying out activities at work
placebo change from baseline at 6 months −2.14 (0.17)
levoceterizine change from baseline: −2.93 (0.17), difference vs placebo 95% CI 0.79 (0.32; 1.26), p<0.001
Difficulty getting sleep
placebo change from baseline at 6 months −1.36 (0.09)
levoceterizine change from baseline at 6 months −1.70, difference vs placebo 95% CI 0.35(0.10; 0.59), p=0.006
Waking up during the night
placebo change from baseline at 6 months: −1.09(0.09), levoceterizine change from baseline at 6 months −1.40 (0.09), difference versus placebo 95% CI 0.31 (0.07; 0.56), p=0.013
Lack of good night’s sleep
placebo change from baseline at 6 months −1.00(0.09)
levoceterizine change from baseline at 6 months −1.50 (0.09), difference vs placebo 95% CI 0.50(0.25; 0.65), p<0.001
Berlin
2000
USA
Double-blind, placebo- controlled, crossover at single centerPAR
Age 18 to 55 years, daytime fatigue, daytime somnolence, nasal congestion, perennial allergic rhinitis with a positive skin test response for perennial allergen (wheal diameter at least 3 mm), and a negative skin test response for seasonal allergens.
Seasonal allergies, known sleep apnea, nasal polyps, obesity, recent upper respiratory tract infection, deviated septum, and asthma or other respiratory diseasesMean age 35 yrs
42% male
Ethnicity NR
Azelastine hydrochloride vs. placeboNoQuestionnaires at baseline and every 2 weeks and a daily diary, which focused on nasal symptoms, sleep, and daytime sleepiness.

Completers analysis
5/NR/19Active treatment vs. Placebo (SE)/Difference estimate (SE)
Congestion 2.223 (0.317) vs. 1.417 (0.372)/0.806 (0.413)
P = 0.09
Daytime sleepiness 2.086 (0.311) vs. 1.263 (0.342)/0.823 (0.377)
P = 0.06
Sleep 2.215 (0.302) vs. 1.303 (0.333)/0.912 (0.375)
P = 0.04
Rhinorrhea 0.408 (0.185) vs. 0.992 (0.158)/0.583 (0.222)
P = 0.03
Congestion 1.271 (0.329) vs. 1.746 (0.198)/0.475 (0.338)
P = 0.20
Sneezing 0.871 (0.256) vs. 0.796 (0.143)/0.075 (0.243)
P = 0.77
Ocular pruritus 0.963 (0.299) vs. 1.004 (0.260)/0.042 (0.345)
P = 0.91
Nasal pruritus 0.933 (0.301) vs. 0.933 (0.290)/0.000 (0.356)
P = 1.00
Bruttman
1989
DB cross over studySuffered from perennial rhinitis for at least one yearPregnant or child bearing potential under 16 or more than 45 yrs oldchronic non-allergic rhinitis, aspirin induced rhinitis, corticosteroid dependency, hepatic or renal deficiency29.4 yrs
66% male
Ethnicity NR
Cetirizine vs. terfenadine or placebo
6 weeks total, 2 weeks in each treatment arm
No but patients were allowed to crossover to next treatment if current treatment was ineffectivePatient diaries, daily record cards, overall patient evaluations at the beginning and at the end of each treatment allocation4/2 LTF/29Most results in graphs
For both active treatments
Conjuctival pruritus baseline 0.5 (0.7) endpoint 0.3
erythema baseline 0.4 (0.8) endpoint 0.2
Cetirizine vs. terfenadine or placebo
Treatment preferences #
Investigator 16* vs. 17* vs. 5
Patient 18* vs. 16* vs. 6 * vs placebo P < 0.05
Ciprandi 2005
Italy
DB RCT, single centerPAR - males and females aged > 18 years, history of PAR due to perennial allergen exposure for the previous 2 years, rhinitic symptoms in the 2 previous weeks with total symptom score (TSS) ≥ 6 at baseline, particularly with moderate to severe nasal obstructionPollen allergy, acute and chronic upper respiratory infections within the previous 30 days, anatomic nasal disorders (i.e., septum deviation), nasal polyps, use of antibiotics, intranasal or oral corticosteroids within the previous 4 weeks, and use of antihistamines during the previous week. Women who were breastfeeding, pregnant, or at risk of becoming soMean 26 yrs
87% male
Ethnicity NR
Desloratadine (5 mg/daily in the morning) or levocetirizine (5 mg/daily in the morning) or placebo (one tablet/daily in the morning) for 4 weeksNo other pharmacological interventions allowedThrough questions made by the investigator: nasal obstruction, sneezing, rhinorrhea, and itchy nose. Each symptom was evaluated on the following scale: 0 = absent, 1 = mild (symptom was present but was not annoying or troublesome), 2 = moderate (symptom was frequently troublesome but did not interfere with either normal daily activity or sleep), and 3 = severe (symptom was sufficiently troublesome to have interfered with normal daily activity or sleep). Total symptom score (TSS) being the sum of each individual symptom was also considered.5/NR/30Data reported in graphs.
TSS decreased significantly both in the desloratadine group (p < 0.05) and the levocetirizine (p < 0.01), whereas placebo-treated patients showed slight increase of TSS.

The intergroup analysis revealed significant differences between levocetirizine and placebo group (p < 0.001), and between desloratadine and placebo group (P < 0.05).

The analysis of single symptoms showed that levocetirizine and desloratadine were more effective than placebo in relieving all symptoms (P < 0.001 and P < 0.05, respectively).
Demoly, 2009
[pollen-induced AR]
France
DB RCT
Multicenter (34)
18 years or older, 2-year history or longer of AR during the natural French cypress pollen season (from January to March), clinically symptomatic with cypress pollen AR at baseline, and had a positive skin prick test result (allergen papule diameter 3 mm) to cypress pollen and/or a positive cypress pollen specific IgE radioallergosorbent test result obtained within 24 months.Pregnancy, lactation, rhinitis medicamentosa, an upper respiratory tract or sinus infection requiring antibiotic therapy within 14 days, a viral upper respiratory tract infection within 7 days, nasal structural abnormalities significantly interfering with nasal airflow, or current evidence of any clinically significant disease or disorder that might interfere with study evaluations or affect patient safety.Mean 40 yrs
44% male
Ethnicity NR
Desloratadine, 5 mg, or placebo for 15 daysProhibited medications (eg, corticosteroids, cromolyn, antihistamines, or leukotriene inhibitors)Patients evaluated symptoms every morning and evening and recorded the results in diaries, along with twice-daily PNIF values. The validated French-language version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was completed by each patient at baseline and on day 14. On day 14, the investigator evaluated the global response to therapy using a 5-point scale (from 1 [complete relief] to 5 [no relief]).100/NR/224Desloratadine vs. placebo
Decrease in total nasal symptom score 40% vs 30%; P = 0.04
Mean individual symptom score 1.2 (47% decrease) vs. 1.6 (37% decrease) P = 0.01
Sneezing 0.59 vs. 0.44 P = 0.02
Itching 0.48 vs 0.29 P = 0.04
Rhinorrhea 0.40 vs 0.35 P = 0.58
Nasal congestion 0.33 vs 0.27 P = 0.35),

RQLQ −1.4 vs. −0.09 P = 0.004
investigator evaluation of global response to therapy mean score 3.4 vs. 3.9; P = 0.004).
Dorow 1987DB RCTPresence of rhinorrhea, sneening, itching nose and eyes and lacrimationNRMean age 42.4 yrs
63% male
Ethnicity NR
Azelastine vs. placebo 1 weekNRPatient records of symptoms, physiciansd overall assessment at endpointNR/NR/16Azelastine vs. placebo
Physician rated good or very good 7/8 vs. 0/8 P = 0.001
Symptoms moderate or severe day 1/day 8
Sneezing 8/1 vs. 7/6 P = 0.009
Itchy nose 8/1 vs. 7/6 P = 0.009
Swelling nasal mucosa 5/1 vs. 6/5 P =0.067
Rhinorrhea 4/1 vs. 6/4 P = 0.262
Frolund
1990
Norway
RCT, DB, placebo-and active- controlled, parallel group, multi-centerPAR
Pts participating were between the ages of 18–65 years, of either sex with an unequivocal history of perennial allergic rhinitis, and with intermittent or continuous nasal symptoms of at least 1 year. The combined symptom score had to be at least 4.
Excluded from the trial were pts with a history of idiosyncratic reactions to antihistamines or multiple drug allergies or if they had any concurrent disease that would interfere with study results or require treatment, if pregnant, or lactating. Further, pts should not have nasal polyps, deviated septa or any structural defect which might cause nasal obstruction or interfere with clinical evaluation. Pts should not have any ongoing SAR during the study period. Further exclusion criteria: pre-seasonal or co-seasonal immunotherapy with antigen extracts started within 12 m prior to the study, or any maintenance dose of these preparations during the last 12 m before entering the study. Similarly, enrollment was not allowed for pts who had received the following specified type of medication prior to the study start: therapy with loratadine within 3m, systemic or topical corticosteroids, sodium cromoglycate (cromolyn sodium) within 2 wks prior to study, decongestants within 24 h, astemizole within 4 wks, and antihistamines other than astemizole 3 d prior to study.
Pts with clinically significant, abnormal laboratory test results were excluded.
Age range: 18–65

Sex: NR

Ethnicity: NR
L: loratadine 10 mg qd
C: clemastine 1 mg bid
P: placebo
NRPts recorded daily nasal (discharge, stuffiness, itching and sneezing) symptom scores 0 (no symptoms) to 3 (severe symptoms), and were to monitor onset of relief in a separate form delivered at visit 1. A new diary card for symptom score recoding during the forthcoming treatment period was distributed to the pts at each visit.

Rhinoscopy was made at each visit to assess nasal membranes, secretion and patency (0=normal, 3=abnormal).
25/NR/130TSS 1 weeks:
L significantly better than C (p<0.05, *estimated from figure)
L vs C vs P: −49% vs −31% vs −10%
TSS 2 weeks/3 weeks:
NSD between active treatments, significant vs. P (p<0.05 *estimated from figure at 2/3 weeks)
L vs C vs P: − 61%/53% vs −40%/44% vs −8%/10%
Nasal symptom scores:
L significantly better than C at 1 week for nasal itching, stuffiness, p <0.05 (concurred w/patient diaries);
NSD at 2 or 3 weeks.
Active treatment significant vs P, p<0.01.
Eye symptoms scores:
NSD between active treatments. Active treatments significantly better than P for itching/redness p<0.05, NS for tearing.
Rhinoscopy: Active treatments significantly better vs. P, p<0.05
Onset: L significant vs. C at day, p<0.05.
* Diary responses not individually reported
Golden 2000
USA
Double-blinded, crossover fashion Single centerAged 18 to 55, year round symptoms, poor sleep quality, daytime somnolence, daytime fatigue, nasal congestion, perennial allergic rhinitis with skin test positive for perennial allergens (wheal greater than 3 mm), and otherwise healthy individuals.Seasonal allergies by skin test or history, obesity, sleep apnea, nasal polyps, asthma, deviated nasal septum, tobacco abuse, and recent upper respiratory tract infection.NRAzelastine nasal spray or placebo (saline nasal spray) at two sprays per nostril BID

8 weeks, crossover at 4 weeks
None allowedDaily diary, sleep diary, questionnaires, and the Epworth Sleepiness Scale.5/0/19Azelastine vs. placebo (SE)
Rhinitis severity score
Runny nose 0.408 (0.185) vs. 0.992 (0.158) P = 0.03
Nasal congestion 1.271 (0.329) vs. 1.746 (0.198) P = 0.197
Sneezing 0.871 (0.256) vs. 0.796 (0.143) P = 0.766
Itching eyes 0.963 (0.229) vs. 1.004 (0.260) P = 0.907
Itching nose/throat 0.933 (0.301) vs. 0.933 (0.290) P = 1
Symptom Severity Questions from Daily Diary
Nasal congestion 1.587 (0.368) vs. 1.555 (0.207) P = 0.932
Daytime sleepiness 1.515 ((0.281) vs. 1.578 (0.219) P = 0.837
Daytime fatigue 1.669 (0.249) vs. 1.676 (0.214) P = 0.98
Sleep problems 1.228 (0.232) vs. 1.073 (0.165) P = 0.526
Symptom Improvement With Medication Questions from Daily Diary
Night time sleep quality 2.215 (0.302) vs. 1.303 (0.333) P = 0.041
Daytime sleepiness 2.086 (0.311) vs. 1.263 (0.342) P = 0.060
Nasal congestion 2.223 (0.317) vs. 1.417 (0.372) P = 0.87
Hampel 2006
USA
DB RCT, three-armed study, multicenter12 years of age or older and had at least a 2-year history of nonrecalcitrant SAR defined by case history and positive allergen skin test.Concurrent upper airway disease, used prohibited medications that would confound the evaluation of the study drug, or were known to be unresponsive to antihistamine therapyMean age 39 yrs
33.6% male
64.6% white
29.2% Hispanic
4.4% black
1.3% Asian
0.4% other races.
Olopatadine 0.6%
Olopatadine 0.4%
Placebo
For 2 weeks
NR except as noted in exclusionRQLQ administered to all patients at the randomization and the end of treatment visits and patient recorded diaries for symptomsNR/NR/675Olopatadine 0.6% vs. Olopatadine 0.4% vs. Placebo (SD)
RQLQ
Overall mean change 1,1* vs. 1.1* vs 0.8
Activities 1.3 (1.6)* vs. 1.2 (1.6) vs. 0.9(1.5)
Sleep 1.3 (1.7)* vs. 1.1 (1.6) vs. 0.8 (1.6)
Non–nose/eye symptoms 0.9 (1.5) vs.0.9 (1.4)* vs. 0.6 (1.3)
Practical problems 1.3 (1.8)* vs. 1.4 (1.6)* vs. 0.8(1.6)
Nasal symptoms 1.3 (1.6)* vs. 1.3 (1.5)* vs. 0.9 (1.4)
Eye symptoms 1.3 (1.6)* vs. 1.2 (1.6)* vs. 0.8 (1.4)
Emotional function 1.1 (1.6)* vs. 1.0 (1.6)* vs. 0.7 (1.4)

TNSS mean % change 30.1* vs. 27.6* vs. 18.7 * vs. placebo P < 0.05
Ho 2007
Taiwan
Allergic rhinitis
Randomized trial, Center NRAllergic rhinitis
Healthy adult men and women who had a clinical history of allergic rhinitis for at least 2 years and who tested positive only for mite allergy in the multiple allergen simultaneous test.
Any chronic nasal diseases or if they had received corticosteroid nasal spray, oral antihistamine, oral decongestant, or oral corticosteroids in the past 3 months.Age range 18 to 68 years
62% male
Ethnicity NR
No treatment (P group), 10 mg of cetirizine once per day (C group), 20 mg of zafirlukast once per day (Z20 group), 20 mg of zafirlukast twice per day (Z40 group), a combination of 20 mg of zafirlukast and 10 mg of cetirizine once per day (Z20 C group), or a combination of 20 mg of zafirlukast twice per day and 10 mg of cetirizine once per day (Z40 C group).
1 month
NRPatients assessed their subjective sensations of sneezing, rhinorrhea, and nasal obstruction. Symptoms were graded on a scale of 0–10, with 0 representing no perceived symptoms and 10 representing the greatest severity of symptoms imaginable, at baseline and after treatment.NR/NR/120Data reported in graphs

Total symptom score improved after treatment in the treated group (p = 0.05; ). High-dose anti-LT alone (Z40) and the combination of anti-LT, including low- and high-dose, and antihistamine (Z20 C and Z40 C) caused better results than the low-dose anti-LT (Z20) or antihistamine (C) alone. In the C group, the symptoms of sneezing and rhinorrhea improved significantly, but nasal obstruction did not improve. In the Z20 group, rhinorrhea improved, but sneezing and nasal obstruction did not. All allergic symptoms, including sneezing, rhinorrhea, and nasal obstruction, were significantly reduced after Z40, Z20 C or Z40 C treatment; however, the treatment effect was similar in Z40, Z20 C, and Z40 C groups
Holmberg 2009 France and Sweden Persistent allergic rhinitisDB RCT 115 hospital units and private centersPAR
Aged 18–65 years, had a positive skin prick test or radioallergosorbent test of class 2 or more to house dust mite or cat dander within 24 months prior to screening, and had at least a 2-year history of moderate-to-severe nasal symptoms associated with allergen exposure.
History of allergic reactions to H1-receptor antagonists or multiple drug allergies; any clinically relevant disease or structural defect that might interfere with study evaluations; or asthma, with the exception of mild intermittent asthma; intranasal or systemic corticosteroid or an investigational drug within 30 days.Mean age 34.4 yrs
48% male
Ethnicity NR
Desloratadine 5 mg/day (n = 293) or placebo/day (n = 291) for 28 days.Concomitant medications that would interfere with the evaluations were not permitted; could not have received specific immunotherapy within 4 months.Mean change from baseline to the end of the study in the nasal congestion score recorded twice daily, the 28-item RQLQ (14) at baseline, on days 7 and 28.Per article more than 80% completed/LTF NR/584Desloratadine vs. placebo
RQLQ scores (SD) at day 28
Activity limitation 2.8 (1.5) vs. 3.2 (1.6) P = 0.005
Sleep problems 1.7 (1.4) vs.1.9 1.5) P = 0.018
General problems 1.7 (1.3) vs. 1.9 (1.3) P = 0.012
Practical problems 2.5 (1.6) vs. 2.9 (1.6) P = 0.004
Nasal symptoms 2.4 (1.3) vs. 2.7 (1.4) P = 0.0002
Ocular symptoms 1.4 (1.4) vs. 1.5 (1.5) P = 0.35 (ns)
Emotional function 1.5 (1.2) vs.1.8 (1.4) P = 0.007
Total score 1.9 (1.1) vs. 2.2 (1.2) P = 0.008

Desloratadine vs. placebo mean change from baseline in a.m./p.m. total nasal symptom score and rhinorrhea score (both P ≤ 0.01).
Most data reported in graphs.
Kim 2006
Multinational
Randomized, double-blind, placebo- controlled trial, multicenter (67)12 years or older with a history of PAR for at least 2 years. Patients were required to have a TSS of 9 or greater, a TNSS of 5 or greater, and a TNNSS of 4 or greater at the initial screening visit and a positive skin prick response to an appropriate perennial allergen (eg, dust mites or animal dander) within 12 months of the studyStructural abnormalities that interfered with nasal airflow, a current diagnosis or a history of acute or chronic sinusitis, chronic purulent postnasal drip, rhinitis medicamentosa, asthma that required regular use of systemic or inhaled corticosteroids, or a skin test that demonstrated mold as the only qualifying perennial allergen. Additional exclusion criteria included the use of any investigational drugs within 30 days of screening and dependence on nasal topical antihistamines, nasal corticosteroids, or nasal, oral, or ocular decongestants. Patients receiving immunotherapy were excluded unless they had been taking medication on a regular maintenance schedule before screening and could maintain this schedule for the duration of the study.Mean age 35 yrs
44% male
83% white
Desloratadine, 5 mg, vs. Placebo

4 weeks
See exclusion criteria and nasal or ophthalmic cromolyn or nedocromil, corticosteroids (other than low- or moderate- potency dermatologic preparations), H1- antihistamines other than desloratadine, leukotriene modifiers, intranasal atropine or ipratropium bromide, ocular or intranasal saline, systemic antibiotics, and nasal, oral, or ocular decongestants were prohibitedThe severity of PAR symptoms, during the preceding 12 hours (reflective) and at the present time (instantaneous), was graded according to a 4-point scale (0 none present; to 3 - signs or symptoms difficult to tolerate and may interfere with daily activities or sleeping [severe]). Scores for individual symptoms combined to obtain the TSS (rhinorrhea, nasal congestion/itching, sneezing, itching/burning eyes, tearing/watering eyes, and itching of the ears/palate), the TNSS (rhinorrhea, nasal congestion/itching, sneezing), and the TNNSS (itching/burning eyes, tearing/watering eyes, and itching of the ears/palate). Patients and investigators jointly evaluated the overall severity of PAR using the same 4-point scale at visits107/NR/1179Desloratadine, 5 mg, vs. Placebo
mean reductions from baseline
TSS
3.9 (mean change, 26.6%) vs. 3.2 (mean change, 22.3%), P = 0.001
TNSS
2.1 (mean change, 23.7%) vs. 1.8 (mean change, 19.8%) P = 0.004
TNNSS
 1.8 (mean change, 30.6%) vs.1.5 (mean change, 25.9%) P < 0.001)
Overall condition of PAR
0.65 [mean change, 24.2%]) vs. 0.53 [mean change, 19.5%]; P = 0.01.
NCT00521131
2007
Double-blind, placebo- controlled, randomized, multicenetr≥ 12 years of age with perennial allergic rhinitis to house dust mites for > 2 years, a positive skin test or positive Radio-Allergo-Sorbent- Test for house dust mites, and having a mean Total 4 Symptoms Score ≥ 5 (T4SS; sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritis and ocular prurtis) over the selection period and a T4SS ≥ 5 on the day before randomization.Pregnant, potentially pregnant or breast feedingMean age 35 yrs
37% male
94% white
2% Asian/Pacific Islander
4% black
Levocetirizine dihdrochloride vs. placebo for 30 daysNRNumber of comfortable days over a 30-day treatment period94/NR/443Levocetirizine dihdrochloride vs. placebo f
Total treatment period mean (SD) 9.36 (9.86) vs. 12.81 (11.08)
Adjusted mean (SE) 9.38 (0.69) vs. 12.78 (0.70)
Difference in adjusted mean (95% Cl), LCTZ 5 mg minus PBO 3.40 (1.48, 5.32)
P = 0.002
Pasquali 2006
Italy
Persistent allergic rhinitis and asthma
RCT, single centerPAR
Adult outpatients (>18 years) of both genders; persistent allergic rhinoconjunctivitis with a history of mild intermittent asthma from at least 2 years or actual asthma (last month). The diagnosis of persistent rhinitis was made on a clinical basis, according to the Allergic Rhinitis and its Impact on Asthma (ARIA) criteria [2], whereas asthma was diagnosed and graded according to GINA guidelines [16]. A positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) for at least house dust mites and/or parietaria.
Anatomical abnormalities of the nose (turbinate hyperthrophy, septal deviation, polyps), pregnancy, persistent asthma, chronic treatment with systemic steroids, malignancies, systemic immunological disorders and ongoing specific immunptherapy.Mean age 35.1 yrs
40% male
Ethnicity NR
Levocetirizine 5mg versus placebo for 8 weeksCromolyn and salbutamol were permitted on demandPatient diary card for symptoms. All symptoms were graded using a score from 0 (absent at all) to 3 (very troublesome).
Five symptoms were considered for rhinoconjunctivitis (so- called T5SS): rhinorrhoea, itching, sneezing, nasal congestion and ocular itching. Also, five lower airways symptoms (cough, wheezing, dyspnoea,
chest tightness, night awakenings); how many times he/she used nasal and ocular cromones and/or salbutamol. A weekly symptom score (possible maximum value 105) was calculated for statistical analysis were recorded throughout the 9 weeks. QoL (generic and specific) and nasal inflammatory cells and mediators were assessed at the end of run-in (visit 2), after 2 (visit 3), 4 (visit 4) and 8 weeks (visit 5) of treatment.
10/0/NR

They start with 50, 10 drop out and they do not report the # analyzed.
Data reported primarily in graphs

T5SS - difference between groups was achieved at week 3 (P = 0.035) and maintained to the end

In the asthmatic patients, the average number of doses of salbutamol was: in the active group 4.75/week at baseline and 2.35/week in the 2 months of treatment; placebo 5.2/week at baseline and 5.0/week at baseline, with a significant difference between groups.
Simons
2003
US and Canada
RCT, DB, placebo- controlled, parallel group, multi- centerAge 12 years or older, history of moderate PAR symptoms of at least 2 years' duration, and had a positive skin test response to 1 or more allergens (house dust mite, cockroach, mold, an animal dander) within the previous 12 months. At the screening visit, they were required to have PAR symptoms with a 12-hour reflecive TSS, including nasal stuffiness-congestion, of at least 10 (maximum score 24) and no greater than moderate nasal stuffiness/congestion.
Summed reflective score for congestion during 3 days before baseline was required to be at least 60; overall rhinitis score at baseline was required to be greater than 2 (on a 4-point scale), indicating moderate-to-severe disease. Good general health as confirmed by history, physical exam, hematology, and blood chemistry test, and urinalysis. Women of childbearing potential required to have a negative serum pregnancy test at screening and to use a medically accepted method of contraception before screening and during the study.
SAR triggered by an allergen pollinating during the time of the study, structural abnormalities interfering with nasal airflow, upper respiratory tract or sinus infection requiring antibiotic treatment withn 14 days before screening, a viral upper respiratory tract infection during the 7 days before screening, and current or past history of recurrent or chronic sinusitis, chronic purulent postnasal drip, rhinitis medicamentosa, or asthma that necessitated the regular use of inhaled corticosteroids or use of systemic corticosteroids. Also excluded were patients with a history of adverse reactions to more than 2 classes of medications or those with a history of adverse effects to antihistamines. Patients who had used any investigational drug in the 30 days before screening, as well as those judged to be dependent on decongestants (nasal, oral, or ocular), intranasal H-1 antihistamines, or intranasal corticosteroids, were also excluded. Patients receiving allergen immunotherapy excluded unless they were on a regular maintenance schedule before screening and could maintain this schedule for the duration of the study;
desensitization treatment within 24 hours before a study visit was prohibited. Pregnant or nursing women also excluded.
34.8 (range 11–79)
70.6% women
82.0% white, 6.4% black, 1.6% Asian, 9.2%
Hispanic, <1%
other
D: desloratadine 5 mg qd

P: placebo

4 weeks
Pseudoephedrine permitted as needed for treatment of severe nasal congestionSymptom scores recorded on daily diary cards. Symptoms (I.e., rhinorrhea, nasal itching, sneezing, postnasal drip/drainage, itchy/burning eyes, tearing/watering eyes, and itching of ears or palate) were individually assessed on a 4- point scale (0=none, 3=severe). TSS was the sum of the 4 nasal symptoms and 3 non nasal symptoms. Congestion not included in TSS because patients could use pseudoephedrine as needed.
Participants scored severity of PAR twice daily on basis of previous 12 hours (reflective) and at the time of assessment (instantaneous).
Overall severity assessed jointly by investigators and participants at baseline at subsequent visits using a 4-point scale (0=none, 3=severe). Overall response also assessed jointly by investigators and participants at each post baseline visit on a 5-point scale (1=complete relief, 5=treatment failure)
42/NR/NR (676 enrolled)Change from baseline in mean instantaneous TSS (excluding nasal symptoms)
D: −35.0%
P: −27.4%
(p=0.005)
Change from baseline in mean instantaneous TSS (including nasal symptoms)
D: −30.8%
P: −23.8%
(p=0.006)
Change from baseline in mean reflective TSS (excluding nasal symptoms)
D: −37.9%
P: −32.3%
(p=0.007)
UCB
2008
A study evaluating the efficacy and safety of 5 mg levocetirizine oral tablets, once daily versus 10 mg loratadine oral tablets, once daily for the treatment of perennial allergic rhinitis
Randomised, investigator blinded, active-control, parallel-group study Multicenter (2)Male and female, aged 18 to 60 years and were clinically diagnosed with PAR.NRMean age 37 yrs
39% male
100% Asian/Mongolian
5 mg levocetirizine oral tablets, once daily versus 10 mg loratadineNRChange of investigator assessed T5SS from baseline to end of treatment at 14 days5/NR/71Least Square mean changes from baseline of T5SS was −4.54 for LCTZ group and −3.83 for LRTD group, P = 0.3552

From: Evidence Tables

Cover of Drug Class Review: Newer Antihistamines
Drug Class Review: Newer Antihistamines: Final Report Update 2 [Internet].
Carson S, Lee N, Thakurta S.
Portland (OR): Oregon Health & Science University; 2010 May.
Copyright © 2010 by Oregon Health & Science University, Portland, Oregon 97239. All rights reserved.

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