Seasonal rhinitis and azelastine: long- or short-term treatment?

J Allergy Clin Immunol. 1997 Mar;99(3):301-7. doi: 10.1016/s0091-6749(97)70046-0.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Adolescent
  • Adult
  • Double-Blind Method
  • Epithelial Cells
  • Epithelium / immunology
  • Female
  • Histamine H1 Antagonists / administration & dosage*
  • Histamine H1 Antagonists / adverse effects
  • Histamine H1 Antagonists / therapeutic use*
  • Humans
  • Immunohistochemistry
  • Intercellular Adhesion Molecule-1 / analysis
  • Leukocyte Count
  • Male
  • Medical Records
  • Middle Aged
  • Nasal Mucosa / cytology
  • Nasal Mucosa / drug effects
  • Nasal Mucosa / immunology
  • Neutrophils / drug effects
  • Neutrophils / immunology
  • Phthalazines / administration & dosage*
  • Phthalazines / adverse effects
  • Phthalazines / therapeutic use*
  • Pollen / immunology
  • Radioallergosorbent Test
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Skin Tests


  • Histamine H1 Antagonists
  • Phthalazines
  • Intercellular Adhesion Molecule-1
  • azelastine