Clinical burden of asynchrony in patients with asthma when using metered-dose inhalers for control.

Background: Asynchrony, or lack of coordination between inhalation and actuation when using a pressurized metered-dose inhaler (MDI), could theoretically impact the delivery of inhaled medications and treatment efficacy. Objective: To assess the real-world association between asynchrony and clinical outcomes among patients with asthma who receive controller therapy delivered by MDIs. Methods: A cohort of patients was assembled via electronic health records. The patients were aged ≥12 years, with one or more documentations of an asthma diagnosis, no diagnosis of chronic obstructive pulmonary disease, and two or more prescriptions for an inhalation aerosol corticosteroid alone or with long-acting beta-2-agonist delivered via MDI. Their inhaler technique, demonstrated by using a placebo MDI, was evaluated at a clinic visit by study nurses who used a standardized 10-step checklist. Asynchrony was defined as any gap in timing between inhalation and actuation. Clinical outcomes were assessed via electronic health records during the 6 months before the clinic visit and were compared between patients with and patients without asynchrony by using multivariable regression analyses adjusted for age, gender, asthma severity proxy, and baseline comorbidities. Results: Of the total 254 eligible patients, mean age of 49.3 years, 90 males (35.4%), 32 (12.6%) had asynchrony. Patients with asynchrony had higher odds of an asthma exacerbation (adjusted odds ratio, 2.99; p = 0.009), and lower odds of risk domain asthma control (adjusted odds ratio, 0.41; p = 0.04) compared with patients without asynchrony. Conclusion: This study provided real-world evidence that asynchrony in MDI use among patients with asthma who were treated with controller MDIs was associated with clinical burden in terms of asthma exacerbations and control.

Beclomethasone Dipropionate Nasal Aerosol in Patients with Perennial Allergic Rhinitis (BALANCE) study: 6-month results.

BACKGROUND: Perennial allergic rhinitis (PAR) exerts significant quality-of-life and economic burdens on society. Beclomethasone dipropionate (BDP) nasal aerosol is the first nonaqueous, hydrofluoroalkane-propelled intranasal corticosteroid approved for patients in the United States to treat PAR and seasonal allergic rhinitis. OBJECTIVE: To evaluate real-world effectiveness of BDP nasal aerosol from the patient's perspective by using a postmarketing observational registry. METHODS: Patients (N = 824) from 43 U.S. study sites completed monthly patient-reported outcome instruments, including the Rhinitis Control Assessment Test (primary outcome variable), Treatment Satisfaction Questionnaire for Medication, Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-Specific, Pittsburgh Sleep Quality Index, and Mini Rhinoconjunctivitis Quality of Life Questionnaire for 6 months. RESULTS: The primary outcome assessment (Rhinitis Control Assessment Test score) (N = 527) indicated significant symptomatic improvement over baseline beginning at month 1 (p < 0.001), with >78.8% of respondents who achieved clinically meaningful improvement over 6 months. Secondary outcome measures Mini Rhinoconjunctivitis Quality of Life Questionnaire (p < 0.001), Pittsburgh Sleep Quality Index (p < 0.001), and Treatment Satisfaction Questionnaire for Medication-9 scales of effectiveness (p < 0.001), global satisfaction (p = 0.001), and patient-rated convenience (p = 0.03), significantly increased from baseline to month 6. Five of seven measurements of the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-Specific, with the exception of work time missed and class time missed, were significantly (p < 0.001) improved in patients treated with BDP compared with baseline. CONCLUSIONS: Treatment with nonaqueous BDP nasal aerosol in a real-world setting significantly improved PAR symptoms and measures of quality of life, work, and school-related activities, and is associated with high patient satisfaction, reduced productivity loss and activity impairment, and improvement in sleep quality.

Real-world health care utilization in asthma patients using albuterol sulfate inhalation aerosol (ProAir ® HFA) with and without integrated dose counters.

BACKGROUND: Accurate tracking of the administered dose of asthma rescue inhalers is critical for optimal disease management and is related to reductions in rates of unscheduled health care utilization in asthma patients. There are few published data on the real-world impact of rescue inhalers with integrated dose counters (IDCs) on health care resource utilization (HRU) for asthma patients. This study evaluates HRU among users of ProAir® hydrofluoroalkane (HFA) (albuterol sulfate inhalation aerosol), with IDC versus without IDC, in asthma patients. METHODS: This was a retrospective administrative claims study of asthma patients receiving a new prescription for albuterol inhalation aerosol without IDC during 2 years (January 2011-December 2012) or with IDC during the first full year after IDC implementation in the USA (July 2013-July 2014). Six months of continuous enrollment with medical and prescription drug benefits were required before and after the first prescription during the study period. Data on respiratory-related hospitalizations and emergency department (ED) visits were collected during the follow-up period. RESULTS: A total of 135,305 (32%) patients used albuterol inhalation aerosol with IDC, and 287,243 (68%) patients received albuterol inhalation aerosol without IDC. After adjusting for baseline confounding factors, the odds ratio (OR) for experiencing a respiratory-related hospitalization (OR=0.92; 95% confidence interval [CI] 0.88-0.96) or ED visit (OR=0.92; 95% CI 0.90-0.94) was significantly lower among patients using albuterol inhalation aerosol with IDC versus without IDC. CONCLUSION: In a real-world setting, asthma patients using ProAir HFA with IDC experienced significantly fewer hospitalizations and ED visits compared with patients using ProAir HFA without IDC. Dosage information provided by IDCs may allow providers to better understand patients' disease severity and aid in titrating controller medications and also decrease the likelihood that the canister will be empty when needed, thereby enhancing disease management and reducing HRU.