Abstract | BACKGROUND: OBJECTIVE: METHODS: In a randomized, placebo-controlled, double-blinded, crossover study, 25 subjects (16 male, 9 female; median age, 28 years) with histories of allergic rhinitis but asymptomatic at screening received roflumilast (500 microg once daily) and placebo for 9 days each with a washout period of at least 14 days in between treatment periods. In each of the treatment periods, controlled intranasal allergen provocation with pollen extracts was performed daily beginning the third day of treatment, each time approximately 2 hours after study drug administration. Five and 30 minutes after each allergen provocation, rhinal airflow was measured by means of anterior rhinomanometry and the subjective symptoms obstruction, itching, and rhinorrhea were assessed by means of a standardized visual analog scale. RESULTS: Rhinal airflow improved almost consistently during the 9 days of roflumilast treatment, and it was significantly higher at study day 9 on roflumilast in comparison with placebo, a result also found for itching and rhinorrhea. With respect to the subjective obstruction score, a significant difference in comparison with placebo could be demonstrated within 4 days. CONCLUSION:
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Authors | B M Schmidt, M Kusma, M Feuring, W E Timmer, M Neuhäuser, T Bethke, B A Stuck, K Hörmann, M Wehling |
Journal | The Journal of allergy and clinical immunology
(J Allergy Clin Immunol)
Vol. 108
Issue 4
Pg. 530-6
(Oct 2001)
ISSN: 0091-6749 [Print] United States |
PMID | 11590377
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Aminopyridines
- Benzamides
- Cyclopropanes
- Phosphodiesterase Inhibitors
- Roflumilast
- 3',5'-Cyclic-AMP Phosphodiesterases
- Cyclic Nucleotide Phosphodiesterases, Type 4
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Topics |
- 3',5'-Cyclic-AMP Phosphodiesterases
(antagonists & inhibitors)
- Aminopyridines
(adverse effects, therapeutic use)
- Benzamides
(adverse effects, therapeutic use)
- Cyclic Nucleotide Phosphodiesterases, Type 4
- Cyclopropanes
- Female
- Headache
(chemically induced)
- Humans
- Male
- Nasal Provocation Tests
- Phosphodiesterase Inhibitors
(adverse effects, therapeutic use)
- Rhinitis, Allergic, Seasonal
(drug therapy)
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