Abstract | BACKGROUND: 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.
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Authors | G Ciprandi, V Ricca, G Passalacqua, T Truffelli, C Bertolini, N Fiorino, A M Riccio, M Bagnasco, G W Canonica |
Journal | The Journal of allergy and clinical immunology
(J Allergy Clin Immunol)
Vol. 99
Issue 3
Pg. 301-7
(Mar 1997)
ISSN: 0091-6749 [Print] United States |
PMID | 9058684
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Histamine H1 Antagonists
- Phthalazines
- Intercellular Adhesion Molecule-1
- azelastine
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Topics |
- Administration, Intranasal
- Adolescent
- Adult
- Double-Blind Method
- Epithelial Cells
- Epithelium
(immunology)
- Female
- Histamine H1 Antagonists
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Immunohistochemistry
- Intercellular Adhesion Molecule-1
(analysis)
- Leukocyte Count
- Male
- Medical Records
- Middle Aged
- Nasal Mucosa
(cytology, drug effects, immunology)
- Neutrophils
(drug effects, immunology)
- Phthalazines
(administration & dosage, adverse effects, therapeutic use)
- Pollen
(immunology)
- Radioallergosorbent Test
- Rhinitis, Allergic, Seasonal
(drug therapy)
- Skin Tests
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