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

Allergy Asthma Proc. 2016 Mar-Apr;37(2):121-30. doi: 10.2500/aap.2016.37.3939. Epub 2016 Feb 2.

Abstract

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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Beclomethasone / administration & dosage*
  • Beclomethasone / adverse effects
  • Comorbidity
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nasal Sprays*
  • Patient Satisfaction
  • Quality of Life
  • Rhinitis, Allergic, Perennial / diagnosis
  • Rhinitis, Allergic, Perennial / drug therapy*
  • Rhinitis, Allergic, Perennial / epidemiology
  • Risk Factors
  • Surveys and Questionnaires
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Nasal Sprays
  • Beclomethasone