Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis

BACKGROUND: Allergic rhinitis (AR), an inflammatory disease of the nasal mucosa, affects approximately 25% of adults and 40% of children in the United States. Ciclesonide nasal spray is a corticosteroid being developed as a hypotonic formulation for AR. OBJECTIVE: We sought to evaluate the efficacy, safety, and tolerability of ciclesonide nasal spray in adult and adolescent patients with seasonal AR (SAR). METHODS: In this double-blind study patients (age, >or=12 years) were randomized to receive 200 microg of intranasal ciclesonide (n = 164) or placebo (n = 163) once daily for 28 days. The primary measure was morning and evening patient-assessed reflective total nasal symptom score (TNSS). Additionally, instantaneous TNSSs, physician-assessed overall nasal signs and symptoms severity, and the results of the Rhinoconjunctivitis Quality of Life Questionnaire were evaluated. Adverse events were monitored throughout the study. RESULTS: Ciclesonide significantly improved average morning and evening reflective and instantaneous TNSSs compared with placebo over days 1 to 14 (P < .001). Improvements were also noted over days 1 to 28 (P < .001) and over days 15 to 28 (P = .011). Ciclesonide was well tolerated. CONCLUSION: Intranasal ciclesonide was superior to placebo in relieving nasal symptoms in adult and adolescent patients with SAR. These results confirm the dose range-finding study in patients with SAR and support the efficacy of ciclesonide in AR. CLINICAL IMPLICATIONS: In a clinical setting ciclesonide was shown to be safe and effective in the treatment of SAR in adolescent and adult patients.     

Efficacy and safety of desloratadine in the treatment of perennial allergic rhinitis

BACKGROUND: The evidence base for the use of H1-antihistamines in the treatment of perennial allergic rhinitis is considerably smaller than it is in the treatment of seasonal allergic rhinitis. OBJECTIVE: We hypothesized that desloratadine, a new, nonsedating selective H1-antihistamine, would be efficacious and safe in the treatment of perennial allergic rhinitis. METHODS: In a multicenter, randomized, placebo-controlled, double-blind, parallel-group study, 676 patients with symptomatic perennial allergic rhinitis were randomly assigned to 4 weeks of treatment with either 5 mg of desloratadine once daily or placebo. Efficacy was assessed by using a morning-evening instantaneous total symptom score (TSS), which was composed of scores for 4 individual nasal symptoms (rhinorrhea, itching, sneezing, and postnasal drip) and 3 individual nonnasal symptoms (itching eyes, watering eyes, and itching of the ears or palate). Secondary outcome measures included a morning-evening reflective TSS, total nasal and nonnasal symptoms scores, and individual symptom scores. Safety evaluations, including 12-lead electrocardiograms, were performed. RESULTS: Six hundred thirty-four patients completed the study. Desloratadine consistently diminished perennial allergic rhinitis symptoms, reducing the morning-evening instantaneous TSS (P =.005), the morning-evening reflective TSS (P =.007), the morning-evening reflective total nonnasal score (P =.023), and the individual nasal symptom scores for rhinorrhea, nasal itching, sneezing, and postnasal drip/drainage (P =.05 to P =.013) during weeks 1 through 4. Improvement in symptoms was observed after the first dose. Dropouts, and the type and frequency of adverse events (headache, viral infection, pharyngitis, and upper respiratory tract infection), were similar in both treatment groups. No clinically significant changes in QTc intervals were observed. CONCLUSIONS: Desloratadine rapidly and safely reduced the symptoms of perennial allergic rhinitis, and its efficacy did not diminish during 4 weeks of treatment.     

Efficacy and safety of cetirizine therapy in perennial allergic rhinitis.

A double-blind, placebo-controlled trial was undertaken to assess the safety and efficacy of once daily cetirizine in alleviating the symptoms of perennial allergic rhinitis. Subjects were adults with perennial allergic rhinitis, characterized by nasal congestion, postnasal discharge, sneezing, rhinorrhea, nasal itching, lacrimation, ocular itching, and itching of the roof of the mouth, and a total pretreatment symptom severity score of greater than or equal to 8. Patients were randomized to treatment with 10 mg cetirizine, 20 mg cetirizine, or placebo for 4 weeks. Efficacy was assessed in 215 patients and safety in 216. Cetirizine in once daily dosages of 10 or 20 mg proved to be effective in relieving the overall symptoms of perennial allergic rhinitis and particularly postnasal discharge and sneezing. The 10-mg dose afforded optimal symptomatic relief, and the 20-mg dose provided little or no additional benefit. Cetirizine was well tolerated, and the frequency of somnolence was not significantly greater in patients receiving this drug than in those given placebo.     

Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis.

BACKGROUND: Ciclesonide is a corticosteroid in development for allergic rhinitis that has been shown to be safe and effective in seasonal allergic rhinitis and perennial allergic rhinitis (PAR) trials of up to 6 weeks in duration. However, the long-term safety and efficacy of ciclesonide are unknown. OBJECTIVE: To demonstrate the long-term safety of intranasal ciclesonide, 200 microg once daily, in patients with PAR. METHODS: Patients (> or = 12 years old) with a 2-year or longer history of PAR were randomized in a double-blind fashion to receive ciclesonide, 200 microg, or placebo once daily in the morning for up to 52 weeks. Spontaneous and elicited adverse events were monitored throughout the study. Ear, nose, and throat examinations were performed to evaluate local tolerability. Additionally, 24-hour urinary free cortisol level, morning plasma cortisol level, intraocular pressure, and lens opacification were monitored to evaluate the systemic safety of intranasal ciclesonide. Ciclesonide efficacy was determined by measuring 24-hour reflective total nasal symptom scores. RESULTS: No clinically relevant differences were observed between the ciclesonide and placebo groups in adverse events, ear, nose, and throat examinations, or 24-hour urinary free or morning plasma cortisol levels. Similarly, no clinically relevant differences were found between treatment groups in intraocular pressure, visual acuity, or lens opacification. With regard to efficacy, ciclesonide achieved a significantly greater reduction in 24-hour reflective total nasal symptom score compared with placebo over more than 52 weeks (P < .001). CONCLUSION: In this study, intranasal ciclesonide, 200 microg once daily, was safe and effective for the long-term treatment of PAR, with no evidence of tachyphylaxis.     

Comparison of the efficacy of budesonide and fluticasone propionate aqueous nasal spray for once daily treatment of perennial allergic rhinitis

Background: Intranasal corticosteroids, such as budesonide and fluticasone propionate, are widely prescribed in the treatment of perennial allergic rhinitis. Once daily budesonide dry powder and fluticasone propionate aqueous suspension have been found to provide similar efficacy in controlling symptoms of perennial allergic rhinitis. Objective: The purpose of this study was to assess the efficacy and safety of treatment with once daily budesonide aqueous nasal spray. Methods: This study involved a multicenter, blinded, randomized, parallel-group, placebo-controlled trial of adults with perrenial allergic rhinitis. Patients (n = 273) recorded daily nasal symptoms for 8 to 14 days (baseline) and 6 weeks (treatment). Results: Budesonide decreased combined symptoms to a significantly greater extent than did fluticasone (P = .03); both treatments significantly decreased mean combined nasal symptoms scores compared with placebo. Of the 3 nasal symptoms assessed (ie, nasal blockage, runny nose, and sneezing), nasal blockage was significantly (P = .009) more decreased with budesonide compared with fluticasone. Both treatments also significantly improved runny nose and sneezing compared with placebo. Improvement in combined nasal symptom scores of the budesonide-treated group reached statistical significance within 36 hours compared with placebo (P = .01); in those patients treated with fluticasone, significant improvement compared with placebo was first observed within 60 hours. Adverse events were mild and transient. Conclusions: Once daily budesonide aqueous nasal spray, 256 μg, was significantly better in controlling the symptoms of perrenial allergic rhinitis than once daily fluticasone propionate, 200 μg, especially nasal blockage. Both treatments were superior to placebo. Budesonide may have a faster onset of action than fluticasone. (J Allergy Clin Immunol 1998;102:902-8.)     

Assessment of the efficacy and safety of three dose levels of cetirizine given once daily in children with perennial allergic rhinitis

The present study compared the efficacy and safety of three dose levels of cetirizine (2.5. 5, and 10 mg) once a day with placebo over 14 days in 6–12-year-old children with perennial allergic rhinitis. The design was a double-blind, randomized, multicenter, parallel-group study. Five symptoms (sneezing, nasal discharge, nasal obstruction, nasal pruritus, and ocular pruritus) were rated according to severity by investigators at the visits and daily by patients. Eighty-three patients were randomized to placebo, 84 to 2.5 mg cetirizine, 85 to 5 mg cetirizine, and 76 to 10 mg cetirizine. Groups were comparable at inclusion. The primary efficacy variable was the percentage of days with no or only mild symptoms: at all doses, cetirizine appeared to be more effective than placebo, but a significant difference was reached only in the 10-mg group (difference in medians of 22%; P = 0.016). The test of linearity was significant ( P = 0.026) for the percentage of asymptomatic days. The investigators' assessments at each visit scored the symptoms in the placebo group higher, i.e., more severe, than in the active groups, the 10-mg dose causing the greatest reduction in symptoms. Adverse events were infrequent and generally mild or moderate in severity. It was concluded that cetirizine at a 10-mg, once daily dose could be used to treat effectively 6–12-year-old children with perennial allergic rhinitis.     

Once daily triamcinolone acetonide nasal spray is effective for the treatment of perennial allergic rhinitis

A randomized, double-blind, placebo-controlled, parallel group study was conducted in 11 centers to evaluate the safety and efficacy of a once-a-day regimen of 110 micrograms, 220 micrograms; and 440 micrograms of triamcinolone acetonide intranasal aerosol versus placebo in relieving the symptoms of rhinitis in 305 adult and older pediatric patients with perennial allergic rhinitis. Nasal stuffiness, nasal discharge, sneezing, nasal itching and the nasal index (the sum of the mean scores of the first three symptoms) averaged over the first 6 weeks and second 6 weeks of the study were significantly reduced in patients who received the 220 micrograms/day and the 440 micrograms/day dosages. The 110 micrograms/day group had a reduction in these nasal symptoms, but only the sneezing and nasal index were significantly (P less than .05) better than placebo. During the last 6 weeks of the study, patients were allowed to take oral back-up medication for their nasal symptoms; all three groups receiving triamcinolone nasal aerosol took less back-up medication than did the placebo group. There were no significant adverse effects or laboratory abnormalities noted during this study. Intranasal triamcinolone acetonide 220 micrograms and 440 micrograms, used once-a-day for 12 weeks is clinically and statistically superior to placebo for the treatment of perennial allergic rhinitis.     

Efficacy and safety of ebastine 20 mg compared to loratadine 10 mg once daily in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled study

BACKGROUND: Few randomized studies have compared loratadine to ebastine in the symptomatic treatment of seasonal allergic rhinitis (SAR) patients. METHODS: This double-blind, placebo-controlled, randomized, parallel-group, comparative trial compared the efficacy and safety of ebastine 20 mg (E20), loratadine 10 mg (L10) and placebo (P), administered once daily, in the control of SAR symptoms over a 2-week period. An additional 2-week treatment period was included in order to check sustained efficacy and tolerability. RESULTS: A total of 703 patients were enrolled: 282 patients in the E20 group, 279 in the L10 group and 142 in the P group. E20 showed a greater decrease from baseline in the main efficacy variable (mean daily reflective total symptom score) than L10 (p = 0.0018) or P (p = 0.0024), whereas the difference between L10 and P was not significant. Moreover, reductions from baseline in all composite/individual daily reflective rhinitis symptom scores were significantly larger in patients receiving E20 than in patients receiving L10 or P. Most significant differences between E20 and L10 or P were maintained after 4 weeks of treatment. Overall, all treatments were safe and well tolerated. There was no significant difference in the percentage of patients who reported one or more adverse events (AEs) between the groups, and most AEs were mild to moderate (89.9%). CONCLUSIONS: E20 given once daily for 2 weeks was more effective in the treatment of SAR symptoms than L10 or P. E20 also showed a sustained efficacy after 4 weeks of treatment, and overall was well tolerated and proved safe.     

Flunisolide aerosol in the treatment of perennial allergic rhinitis.

A double-blind, crossover study was performed with a new topical aerosol steroid, flunisolide, administered every 12 hours over a period of eight weeks to 36 adult patients with perennial allergic rhinitis. During the treatment period the majority of patients had significant relief of symptoms as compared with the placebo period. Most prominent improvement occurred with the symptoms of nasal stuffiness, sneezing, rhinorrhea and the number of times patients had to blow their noses. Best results were obtained in patients with higher degrees of atopy. Side effects were minimal and limited to nasal irritation in some patients. Criteria for optimal patient selection are discussed and an explanation for the lack of systemic effects of aerosolized use of the newer corticosteroids is given.     

A 12‐week, placebo‐controlled study of the efficacy and safety of ebastine, 10 and 20 mg once daily, in the treatment of perennial allergic rhinitis

This double-blind, placebo-controlled, multicentre study investigated the ability of ebastine, 10 and 20 mg once daily, to control symptoms of perennial allergic rhinitis (PAR) over a 12-week period, and assessed additional benefits of the 20-mg dose. Following a 2-week baseline period, patients (12-63 years) were randomized to treatment with ebastine 10 mg (n=88) or 20 mg (n=102), or placebo (n=100). Patients scored symptom severity (0-3) twice daily, and mean changes from baseline scores showed ebastine to be significantly effective in week 1. Control of symptoms persisted over the 12 weeks, the average daily total nasal symptom score for nasal stuffiness plus nasal discharge plus sneezing plus itchy nose being reduced by both doses, with statistical significance at 20 mg (P=0.015 vs placebo) despite decreased usage of sodium cromoglycate rescue medications. Patient and clinician final opinions of treatment also significantly favoured ebastine, both 10 and 20 mg, over placebo. No serious adverse events occurred, and study treatments were well tolerated with a low incidence of central nervous system-related adverse events and headache. In conclusion, ebastine 10 or 20 mg once daily was rapidly effective in relieving symptoms of PAR in adult and adolescent patients; additional benefits of the 20-mg dose became apparent in the longer term.     

A non-comparative trial of the efficacy and safety of fexofenadine for treatment of perennial allergic rhinitis

An open-label, non-comparative study was performed in three Otolaryngology centers in Bangkok, Thailand, to assess the efficacy, safety and tolerability of fexofenadine in Thai patients with perennial allergic rhinitis. Altogether 101 perennial allergic rhinitis patients were included, 33 males and 68 females. Mean age was 33 years, average duration of symptoms was 6 years. All patients received fexofenadine hydrochloride 120 mg once daily (OD) in the morning for 2 weeks. Patients recorded their allergy symptoms daily using a 5 point rating scales in the diary card. At the end of 2 weeks, patients and investigators assessed the overall efficacy of treatment. Adverse events and onset of symptom relief were also recorded by every patient. Blood test and ECG were performed before and after treatment in one center (Siriraj Hospital). Total symptom scores and nasal scores decreased significantly from a baseline at 1 week and 2 weeks after treatment (p < 0.05). The mean onset of symptom relief was 2 hours and 12 minutes. The global assessment of the treatment by patients and investigators showed significant concordance. There was no significant change in either the vital signs, laboratory tests or ECG. The incidence of treatment related adverse events was 8% but all were mild and easily tolerated. Drowsiness was reported from only one patient. This study suggests that fexofenadine 120 mg once daily was an effective, safe and well tolerated treatment for perennial allergic rhinitis in Thai patients.     

Effectiveness of ciclesonide nasal spray in the treatment of seasonal allergic rhinitis.

BACKGROUND: Ciclesonide is an investigational corticosteroid under development for treatment of allergic rhinitis. Ciclesonide is converted to active metabolite, desisobutyryl-ciclesonide (des-CIC), by upper and lower airway esterases. In vitro studies in human nasal epithelial cells and bronchial epithelial cells have demonstrated a long duration of anti-inflammatory activity of des-CIC. OBJECTIVE: To evaluate the dose-dependent efficacy and safety of a hypotonic intranasal formulation of ciclesonide in patients with seasonal allergic rhinitis (SAR). METHODS: This was a phase 2, randomized, parallel-group, double-blind, placebo-controlled study. Adults (n = approximately 145 per treatment group) with a minimum 2-year history of SAR received placebo or ciclesonide (25, 50, 100, or 200 microg/d) for 14 days. The primary end point was change in the sum of morning and evening reflective total nasal symptom scores (TNSSs) over 2 weeks. Safety was monitored throughout the study. RESULTS: Ciclesonide, 100 microg/d (P = .04) and 200 microg/d (P = .003), significantly improved the sum of morning and evening reflective TNSS vs placebo at more than 2 weeks of treatment. Baseline values for morning and evening reflective TNSS ranged from 17.80 to 18.82 across treatment groups. The average change from baseline in reflective TNSS was -4.2 for placebo and -4.8, -4.8, -5.3, and -5.8 for ciclesonide, 25, 50, 100, and 200 microg/d, respectively. There were no dose-related differences in the incidence of adverse events among treatment groups. CONCLUSIONS: Results from this study indicate that 100-microg and 200-microg daily doses of ciclesonide are effective in the treatment of SAR. Ciclesonide, 200 microg/d, appears to be the optimal dose studied for reducing the symptoms of SAR while maintaining an acceptable safety profile.     

A 12-week placebo-controlled study of rupatadine 10 mg once daily compared with cetirizine 10 mg once daily, in the treatment of persistent allergic rhinitis

Background:  With the current increasing incidence of allergies worldwide, new treatments showing efficacy and long term safety are needed for chronic conditions such as persistent allergic rhinitis (PER). New generation H1-antihistamines have demonstrated anti-allergic properties, which could possibly enhance their effectiveness in long-term periods of treatment.
Objective:  To investigate the efficacy of rupatadine, in controlling symptoms of PER over a 12-week period.
Methods:  A randomized, double blind, parallel-group, placebo-controlled study was carried out in patients aged older than 12 years with PER. Main inclusion criteria were: instantaneous total symptom score (i6TSS) ≥45, nasal obstruction score ≤12, and overall assessment of PER ≥2 as moderate during the first visit. The primary efficacy endpoint was the 12-week average change from baseline of the patients' i6TSS.
Results:  In all, 736 patients were selected. Of them, 543 (73.8%) were randomized in three different groups: placebo ( n  = 185), cetirizine ( n  = 175) and rupatadine ( n  = 183). Rupatadine ( P  = 0.008) but not cetirizine ( P  = 0.07) statistically reduced the baseline i6TSS vs placebo (47.8%, 44.7% and 38.8%, respectively), after 12 weeks. Onset of action was observed at the first 24 h for both treatments (rupatadine vs placebo, P  = 0.013; cetirizine vs placebo, P  = 0.015). Furthermore, instantaneous total nasal symptoms score (iTNSS) (including nasal blockage) mean change from baseline showed a significant reduction with rupatadine 10 mg in comparison with placebo, along all treatment duration of 12 weeks. Study treatments were well tolerated.
Conclusion:  Rupatadine significantly relieves symptoms of PER, providing a rapid onset of action and maintains its effects over a long period of 12-weeks.     

Comparison of once daily fluticasone propionate aqueous nasal spray with once daily budesonide reservoir powder device in patients with perennial rhinitis

BACKGROUND: Previous studies comparing the corticosteroids fluticasone propionate (FP) and budesonide (BUD) in both perennial and seasonal rhinitis have shown no consistent difference between treatments. However, the therapeutic outcomes may have been influenced by study design. OBJECTIVE: To compare the effect of FP aqueous nasal spray (ANS; 200 microg/day) with BUD reservoir powder device (RPD; 200 microg/day) on rhinitis symptoms, productivity loss and device preference in patients with perennial rhinitis. METHODS: After a 2-week run-in period, 440 patients were randomized to receive either FPANS, BUD RPD or matched placebo (ANS or RPD) for 8 weeks, followed by an open-label 4-week follow-up treatment with FPANS. Patients completed diary card visual analogue scores for nasal symptoms, and questionnaires on satisfaction with the treatment and preferred choice of device. RESULTS: During weeks 1-4, the visual analogue total nasal symptom scores (VATNS) in the FPANS group were significantly lower than scores in the BUD RPD group (mean difference = -17.8; 95% CI = -34.4, -1.3; P = 0.036). FPANS also significantly reduced the VATNS compared with the ANS placebo at all time-points assessed (P < or = 0.005). BUD RPD did not significantly differ from the RPD placebo at weeks 5-8 (P = 0.167), or the ANS placebo at any time-point (P < or = 0.151). Over the 8-week treatment period FPANS was significantly more effective than BUD RPD at reducing sneezing (mean difference = -4.4; 95% CI = -8.6, -0.3; P = 0.036) and nasal itching (mean difference = -5.3; 95% CI = -9.9, -0.8; P = 0.022), and was significantly superior to the ANS placebo for all symptoms assessed at weeks 1-4 and 1-8 (P < 0.016). At the same time-points BUD RPD was no better at alleviating nasal itching than the RPD placebo (P < or = 0.306), and compared with the ANS placebo, significantly reduced only one symptom; nasal blockage (P < or = 0.016). After 8 weeks of treatment, patients preferred the ANS device to the RPD (P < 0.001), and at 12 weeks a significantly greater number of patients were satisfied with FPANS treatment compared with BUD RPD (P = 0.0019) or the respective placebos (P = 0.0001). CONCLUSION: FPANS and BUD RPD are effective therapies with a good safety profile for the treatment of perennial rhinitis but, in this direct placebo-controlled comparison, FPANS was more efficacious than BUD RPD, and the patients preferred the ANS device to the RPD.     

Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis

BackgroundGSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid).ObjectiveTo evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR).MethodsIn this double-blind study, eligible patients (≥12 years of age) with SAR were randomized 1:1:1:1 to twice-daily GSP301 (665 μg of olopatadine and 25 μg of mometasone), olopatadine (665 μg), mometasone (25 μg), or placebo for 14 days. The primary end point—mean change from baseline in average morning and evening 12-hour reflective Total Nasal Symptom Score (rTNSS)—was analyzed via a mixed-effect model repeated measures (P < .05 was considered to be statistically significant). Additional assessments included average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs).ResultsA total of 1176 patients were randomized. GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (least squares mean difference, -1.09; 95% CI, -1.49 to -0.69; P < .001) and vs olopatadine (P = .03) and mometasone (P = .02). Similar significant improvements in iTNSS were also observed with GSP301 (P < .05 for all). Furthermore, GSP301 significantly improved overall ocular symptoms, individual nasal and ocular symptoms, and quality of life vs placebo (P ≤ .001 for all). Onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent timepoints. Treatment-emergent AEs occurred in 15.6%, 12.6%, 9.6%, and 9.5% of patients in the GSP301, olopatadine, mometasone, and placebo groups, respectively.ConclusionGSP301 is efficacious and well tolerated vs placebo for treating SAR-associated nasal and ocular symptoms, with a rapid onset of action of 15 minutes in adult and adolescent patients 12 years and older.Clinical Trial RegistrationClinicalTrials.gov: NCT02870205.     

The comparison of the efficacy and safety of cetirizine, oxatomide, ketotifen, and a placebo for the treatment of childhood perennial allergic rhinitis.

BACKGROUND: There has been no study comparing the long-term effects of ketotifen, oxatomide, and cetirizine for the treatment of perennial allergic rhinitis among children. OBJECTIVE: We conducted a study to compare the efficacy of the three agents for the treatment of perennial allergic rhinitis among children. METHODS: The study consisted of a double-blind, placebo-controlled, randomized design, comprising 69 perennial allergic rhinitis patients with mite allergy, aged 6 to 12 years, randomly assigned to 1 of 4 test treatment groups for 3 months: 19 in the cetirizine group (10 mg daily), 18 in the ketotifen group (1 mg, twice daily), 16 in the oxatomide group (1 mg/kg, twice daily), and 16 in the placebo group. We used the nasal symptom score of diary card and the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire and eosinophil cation protein peripheral blood total eosinophil count and immunoglobulin E level, eosinophil proportion from a nasal smear, and nasal peak expiratory flow rate to evaluate the effect of the four agents. RESULTS: Cetirizine was significantly more effective at reducing the mean rhinorrhea score compared with oxatomide for both weeks 8 and 12 (P < 0.01). Before the end of week 12, cetirizine was significantly more effective than ketotifen (P < 0.01). Cetirizine and oxatomide significantly decreased the mean Pediatric Rhinoconjunctivitis Quality of Life Questionnaire score compared with the placebo for week 12 (P < 0.05). CONCLUSIONS: Cetirizine was more effective than oxatomide and ketotifen for the relief of nasal congestion and rhinorrhea, and was responsible for significantly decreasing the eosinophil representation of a posttreatment nasal smear.     

Efficacy and safety of fluticasone propionate 250 microg administered once daily in patients with persistent asthma treated with or without inhaled corticosteroids.

BACKGROUND: Studies have shown fluticasone propionate (FP) 100, 200, and 500 microg administered once daily to be effective in the treatment of asthma. The efficacy of a once daily regimen of FP 250 microg has not been evaluated previously. OBJECTIVE: We sought to evaluate the efficacy and safety of inhaled FP 250 microg administered once daily in patients currently receiving inhaled short-acting beta-agonists (SABA) alone or inhaled corticosteroids (ICS). METHODS: In two separate studies, 408 patients in the SABA study and 401 patients in the ICS study were randomly assigned to receive FP 250 microg or placebo for 12 weeks through the Diskus device (GlaxoSmithKline, Research Triangle Park, NC) each morning. RESULTS: At the study endpoint, SABA patients treated with FP and placebo had mean increases in forced expiratory volume in 1 second from baseline of 0.23 +/- 0.03 L and 0.10 +/- 0.03 L, respectively (P < 0.001). ICS patients treated with FP had a mean increase of 0.08 +/- 0.02 L compared with a decrease in forced expiratory volume in 1 second of -0.08 +/- 0.03 L with placebo (P < 0.001). Changes of similar magnitude in morning peak expiratory flow rates were seen with FP in both the SABA and ICS studies. Fewer FP-treated ICS study patients were withdrawn from the study as a result of predetermined asthma stability criteria and, therefore, those patients had a greater probability of remaining in the study than placebo-treated patients (P < 0.001). CONCLUSIONS: FP 250 microg, once daily, produced greater improvements in pulmonary function and asthma symptom control than placebo. This new treatment regimen provides clinicians with an additional therapeutic option for patients with asthma previously treated with either beta2-agonists alone or ICS.     

Efficacy and safety of intranasal budesonide in the treatment of perennial rhinitis in adults and children

The efficacy and safety of intranasal budesonide were evaluated in a placebo-controlled double-blind study of 51 children (6 to 18 years) and 48 adults with perennial (allergic or nonallergic) rhinitis. The trial commenced with a 2-week baseline period without treatment for perennial rhinitis. This was followed by a treatment period of 4 weeks. Treatment was either intranasal budesonide 200 micrograms bid or matching placebo bid. Nasal symptoms were rated daily on a scale from 0 (absent) to 3 (severe). Safety was monitored by laboratory assessments (hematology, blood chemistry, urinalysis) as well as by rhinoscopy and recording of adverse events. Budesonide reduced the nasal symptoms as compared with baseline. The reduction was greater than in the placebo group and symptoms were improved significantly on budesonide treatment compared with placebo. Laboratory assessments demonstrated no differences between budesonide and placebo. Adverse responses to intranasal budesonide were few and minor, and compliance was high. Intranasal budesonide, 200 micrograms bid, thus appears to be efficacious, highly acceptable, and safe for the treatment of perennial rhinitis.