Ocular symptoms improvement from intranasal triamcinolone compared with placebo and intranasal fluticasone propionate: A meta-analysis.

BACKGROUND: Allergic rhinitis is a prevalent disease, which can be classed as seasonal (SAR) or perennial. In addition to nasal symptoms, up to 75% of sufferers experience itching, redness, and tearing of the eyes. Intranasal corticosteroids are effective in controlling the allergic nasal symptoms, and increasing evidence suggests that they also can relieve some of the allergic ocular symptoms. OBJECTIVE: To evaluate the magnitude of efficacy of triamcinolone acetonide (TAA) compared with placebo or fluticasone propionate (FP) on ocular symptom improvement in patients with SAR. METHODS: A meta-analysis of summary data from 8 randomized, double- or single-blind trials, assessing mean change in total or individual (tearing, redness, and itching) eye symptoms was conducted. Trials that administered a daily dose of 220 µg TAA vs placebo or 200 µg FP over at least 2 weeks' duration, in patients aged 12 years or older with SAR, were analyzed. RESULTS: Total eye symptom reduction after 2 weeks was greater with TAA than placebo, with a mean treatment difference of -0.32 (95% CI, -0.444 to -0.203). In addition, significant reductions in tearing, but not itching or redness, were observed after TAA treatment compared with placebo. No significant treatment difference was seen between TAA and FP in total ocular symptoms at any of the time points measured (weeks 1, 2, 3, and overall). All treatments exhibited similar safety profiles and were deemed well tolerated. CONCLUSION: The meta-analysis demonstrated the positive clinical improvements TAA has on total ocular allergy symptoms, especially tearing, in addition to its recognized nasal symptom efficacy in SAR.

Coding Telemedicine Visits for Proper Reimbursement.

PURPOSE OF REVIEW: Coding for patient visits and monitoring via telehealth have expanded over the past years with a wide acceptance of telemedicine as a consequence of the coronavirus pandemic. Coding topics of interest to the allergist/immunologist in regard to services provided via telemedicine will be of increasing importance in the coming years. RECENT FINDINGS: CPT coding for telephone as well as synchronous face-to-face telehealth visits has changed over the past few years. With the need for distancing and patient protection during the coronavirus pandemic, telehealth services have increased dramatically. The introduction of newer devices to remotely monitor patients will increase and be incorporated into patient care. This review will summarize current codes available for designating what services have been provided. The area of telemedicine is changing and will continue to evolve as other platforms for visits are designed and other methods of monitoring patients become available. Coding for these services will be an ongoing need for the provider.

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

BACKGROUND: GSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). OBJECTIVE: To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR). METHODS: In 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). RESULTS: A 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. CONCLUSION: GSP301 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 REGISTRATION: ClinicalTrials.gov: NCT02870205.

Patient satisfaction with beclomethasone dipropionate nasal aerosol device with integrated dose counter during daily use.

Some patients with allergic rhinitis (AR) may prefer a "dry" intranasal corticosteroid aerosol to avoid certain sensory perceptions such as the "wet feeling in the nose" and the "dripping down the throat" associated with aqueous nasal sprays. A nonaqueous hydrofluoroalkane-propelled beclomethasone dipropionate (BDP) nasal aerosol with an established efficacy and safety profile was approved to treat the nasal symptoms associated with AR in adult and adolescent patients. This study was designed to evaluate ease of use and patient satisfaction with the BDP nasal aerosol device in patients with perennial AR (PAR). In this phase 3, randomized, double-blind, parallel-group, placebo-controlled study, eligible patients (≥12 years of age) with PAR were randomly assigned to receive BDP nasal aerosol at 320 micrograms/day or placebo for 6 weeks. At the end of the treatment period, patients assessed device ease of use and satisfaction with the device using a questionnaire with a 5-point representative scale (not at all, not very, neither nor, somewhat, very [certain/easy/satisfactory]). Nearly all patients (89.7%) reported that the BDP nasal aerosol device with integrated dose counter was "very easy" or "somewhat easy" to use. The majority of patients (87.5%) also indicated that it was "very easy" or "somewhat easy" to tell when the device was empty, compared with only 42.3% who were "very certain" or "somewhat certain" of being able to tell when previously used aqueous nasal spray devices were empty. Overall, patient satisfaction with the BDP nasal aerosol device was high: 65.7% responded that they were "very satisfied" or "somewhat satisfied" and only 3.6% were "not satisfied at all" or "not very satisfied." These results indicate that the majority of patients considered the BDP nasal aerosol device easy to use and reported a high degree of satisfaction with the device compared with other nasal sprays they had used in the past.

A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity.

BACKGROUND: Inhaled corticosteroids (ICS) are recommended first-line therapy for the treatment of persistent asthma. However, reports from observational studies have suggested that the use of ICS may be associated with systemic adverse events, such as glaucoma and cataract (opacity of the lens) formation. OBJECTIVE: To compare two ICS over 1 year regarding the formation/progression of lenticular opacities in patients with asthma. METHODS: Adults (>or=18 years of age) with moderate-to-severe asthma were randomized to ciclesonide 640 micro g/day (n = 785) or beclomethasone dipropionate 640 micro g/day (n = 783) in a multinational, double-blind, active-controlled, parallel-group study. The primary endpoint was the occurrence of a positive Class I grading shift (increase [worsening] in Lens Opacities Classification System [LOCS] III score of >or= 0.5 for nuclear opalescence, >or= 0.8 for cortical opacification, or >or= 0.5 for posterior subcapsular opacification, or cataract surgery) in either eye at any visit over the 12-month, double-blind treatment period. RESULTS: Mean changes (+/- standard error) in nuclear opalescence and cortical and posterior subcapsular opacification were small and similar between groups (ciclesonide 640 micro g/day: 0.10 +/- 0.02, 0.07 +/- 0.02 and 0.04 +/- 0.01, respectively; beclomethasone dipropionate 640 micro g/day: 0.11 +/- 0.02, 0.09 +/- 0.02 and 0.03 +/- 0.01, respectively). Class I shifts were observed in 34.3% versus 36.8% of ciclesonide-treated and beclomethasone dipropionate-treated patients, respectively. Ciclesonide 640 micro g/day was non-inferior to beclomethasone dipropionate 640 micro g/day regarding Class I shifts (risk ratio of ciclesonide to beclomethasone dipropionate, 0.940 [95% confidence interval, 0.820-1.077]); the 95% confidence interval upper bound was lower than the pre-specified non-inferiority bound of 1.333 (p < 0.0001), thereby excluding the possibility of higher risk ratio values. CONCLUSIONS: Mean changes in LOCS III scores were very small in both groups. Treatment with ciclesonide 640 micro g/day or beclomethasone dipropionate 640 micro g/day for 1 year has a minimal impact on lenticular opacities development and/or progression.

Allergic rhinitis substantially impacts patient quality of life: findings from the Nasal Allergy Survey Assessing Limitations.

People with allergic rhinitis rate their overall health significantly lower than individuals without nasal allergies. Compared with the general population, more people with AR complain of difficulty getting to sleep, waking up during the night, lack of a good night's sleep, or a combination of these, as a result of their nasal symptoms. More than half of individuals with AR describe their symptoms as impacting daily life a lot or to a moderate degree. More adults with AR report that their health limits them from doing well at work compared with adults without nasal allergies, and their estimated productivity drops by an average of 20% on days when their nasal symptoms are at their worst.

What are the primary clinical symptoms of rhinitis and what causes them?

The nose has a limited repertoire of responses regardless of the triggers. These responses primarily serve as a protective mechanism for the lower respiratory tract. Although the nasal reactions to pollens, particles, and pollution may have a beneficial effect for the lower airway, they create symptoms in some individuals that lead to significant morbidity. The symptoms of allergic rhinitis extend far beyond the nose, and the morbidity associated with rhinitis is significant. The nasal symptoms of rhinitis and their causes are the focus of this review.

Outcomes and costs of patients with persistent asthma treated with beclomethasone dipropionate hydrofluoroalkane or fluticasone propionate.

OBJECTIVE: Examine outcomes and costs of patients with persistent asthma who initiated treatment with beclomethasone dipropionate hydrofluoroalkane (BDP-HFA) or fluticasone propionate (FP). METHODS: MedStat's Commercial Claims and Encounters database (July 1, 2002-June 30, 2007) was utilized. Patients (n=13,968) were included if they initiated treatment with BDP-HFA or FP (first use=index date). Patients also met these criteria: (a) no receipt of other study medication in the 1-year post-period; (b) persistent asthma in the 1-year pre-period; (c) age 5-64 years; (d) no diagnosis of chronic obstructive pulmonary disease; and (e) continuous insurance coverage from 1 year pre-period to 1 year post-period. Multivariate regressions examined the probability of an ER visit or hospitalization, probability of reaching alternative adherence thresholds, and costs. RESULTS: Receipt of BDP-HFA, compared with FP, was associated with a 17% reduction in the odds of an ER visit (OR=0.834, 95% CI 0.751 to 0.925), a 30% reduction in the odds of an asthma-related ER visit (OR=0.697, 95% CI 0.571 to 0.852), and an increase in the odds of obtaining a medication possession ratio (MPR) of at least 50% (OR=1.324; 95% CI 1.164 to 1.506) or 75% (OR=1.311; 95% CI 1.072 to 1.604). Total medical costs ($5063 vs. $5377, P=0.0042), prescription drug costs ($2336 vs. $2581, P<0.0001), and ER costs ($185 vs. $249, P<0.0001) were significantly lower among the BDP-HFA cohort. Asthma-related outpatient ($191 vs. $224, P<0.0001) and ER costs ($28 vs. $45, P<0.001) were significantly lower in the BDP-HFA group, while asthma-related inpatient ($101 vs. $59, P<0.0001) and drug costs ($451 vs. $540, P<0.0001) were significantly lower in the FP cohort. CONCLUSIONS: Results indicate that receipt of BDP-HFA, compared with receipt of FP, is associated with a decreased probability of ER visits or asthma-related ER visits and higher odds of reaching a medical possession ratio threshold of 50% or 75%. Receipt of BDP-HFA was also associated with lower total drug costs and lower total medical costs.