BACKGROUND:Azelastine is a topical antihistamine, clinically demonstrated to be effective in allergic rhinitis. OBJECTIVE: We evaluated the clinical efficacy and the antiallergic activity of azelastine nasal spray, administered 0.56 mg per day, 0.28 mg per day, or on demand over a 3-month period during natural allergen exposure, in a double-blind, placebo-controlled fashion. METHODS:Thirty patients, sensitized to grass or Parietaria pollen, were allocated to three treatment groups: those receiving the standard dosage (0.14 mg/nostril two times a day), half the dosage (0.07 mg/nostril two times a day), or placebo daily for 3 months. All patients were allowed to take additional doses of azelastine when needed. Evaluation parameters were as follows: clinical symptoms recorded on a diary card, number of additional, on-demand azelastine puffs, nasal inflammatory cell count, intercellular adhesion molecule-1 expression on nasal epithelial cells, and pollen count. RESULTS: This study showed the following: (1) the half dose (0.28 mg/day) and the standard dose (0.56 mg/day) were equally effective in reducing clinical symptoms (p = NS), although the standard dosage required fewer additional puffs during times of peak pollen counts (p < 0.05); (2) both dosages were able to reduce the allergic inflammation (p < 0.05 vs placebo); and (3) on-demand use achieved acceptable clinical control but did not significantly reduce allergic inflammation. CONCLUSION: Continuous treatment was more effective than on-demand use as assessed by both clinical evaluation and antiinflammatory action.
RCT Entities:
BACKGROUND:Azelastine is a topical antihistamine, clinically demonstrated to be effective in allergic rhinitis. OBJECTIVE: We evaluated the clinical efficacy and the antiallergic activity of azelastine nasal spray, administered 0.56 mg per day, 0.28 mg per day, or on demand over a 3-month period during natural allergen exposure, in a double-blind, placebo-controlled fashion. METHODS: Thirty patients, sensitized to grass or Parietaria pollen, were allocated to three treatment groups: those receiving the standard dosage (0.14 mg/nostril two times a day), half the dosage (0.07 mg/nostril two times a day), or placebo daily for 3 months. All patients were allowed to take additional doses of azelastine when needed. Evaluation parameters were as follows: clinical symptoms recorded on a diary card, number of additional, on-demand azelastine puffs, nasal inflammatory cell count, intercellular adhesion molecule-1 expression on nasal epithelial cells, and pollen count. RESULTS: This study showed the following: (1) the half dose (0.28 mg/day) and the standard dose (0.56 mg/day) were equally effective in reducing clinical symptoms (p = NS), although the standard dosage required fewer additional puffs during times of peak pollen counts (p < 0.05); (2) both dosages were able to reduce the allergic inflammation (p < 0.05 vs placebo); and (3) on-demand use achieved acceptable clinical control but did not significantly reduce allergic inflammation. CONCLUSION: Continuous treatment was more effective than on-demand use as assessed by both clinical evaluation and antiinflammatory action.
Authors: Philip R Cooper; Jie Zhang; Gautam Damera; Toshinori Hoshi; David A Zopf; Reynold A Panettieri Journal: Allergy Asthma Proc Date: 2011 Sep-Oct Impact factor: 2.587
Authors: G K Scadding; S R Durham; R Mirakian; N S Jones; S C Leech; S Farooque; D Ryan; S M Walker; A T Clark; T A Dixon; S R A Jolles; N Siddique; P Cullinan; P H Howarth; S M Nasser Journal: Clin Exp Allergy Date: 2008-01 Impact factor: 5.018