OBJECTIVE: To assess the efficacy and safety of a pollen blocker crème for prophylaxis of symptoms in patients with seasonal or perennial allergic rhinitis. DESIGN: Double-blind, randomized, placebo-controlled, crossover study conducted from November 2001 through September 2002 in 2 outpatient centers in Germany and 1 in Russia. Ninety-one patients aged 18 to 55 years with at least a 2-year history of seasonal or perennial allergic rhinitis confirmed by history and positive skin test results were randomly assigned to receive pollen blocker cream (n = 43) or carboxymethylcellulose in gel (placebo) (n = 48) applied sparingly to the lower internal nose region 4 times daily for a total of 9 days. The efficacy of treatment was assessed by means of nasal provocation testing. The investigators assessed the nasal symptom severity scores (range, 0-6), and the changes in nasal airflow after allergen application were measured by anterior rhinomanometry. RESULTS: The median score fell from 4 to 1 after application of the pollen blocker cream (P<.001) and from 4 to 3 in the placebo group (P<.05). The difference between the 2 groups after the second provocation was highly significant (P<.001). The increase in airflow in response to treatment was roughly 20% in the blocker group compared with only about 10% in the placebo group, relative to an airflow rate (299 mL/s) measured after provocation on day 1. CONCLUSIONS: The blocker was significantly more effective than placebo and reduced the typical symptoms of allergic rhinitis in response to nasal challenge with allergen by nearly 60% (placebo reduced symptoms by 25%). The pollen blocker cream did not produce any adverse effects. Therefore, the efficacy of the investigational product can be rated as good.
RCT Entities:
OBJECTIVE: To assess the efficacy and safety of a pollen blocker crème for prophylaxis of symptoms in patients with seasonal or perennial allergic rhinitis. DESIGN: Double-blind, randomized, placebo-controlled, crossover study conducted from November 2001 through September 2002 in 2 outpatient centers in Germany and 1 in Russia. Ninety-one patients aged 18 to 55 years with at least a 2-year history of seasonal or perennial allergic rhinitis confirmed by history and positive skin test results were randomly assigned to receive pollen blocker cream (n = 43) or carboxymethylcellulose in gel (placebo) (n = 48) applied sparingly to the lower internal nose region 4 times daily for a total of 9 days. The efficacy of treatment was assessed by means of nasal provocation testing. The investigators assessed the nasal symptom severity scores (range, 0-6), and the changes in nasal airflow after allergen application were measured by anterior rhinomanometry. RESULTS: The median score fell from 4 to 1 after application of the pollen blocker cream (P<.001) and from 4 to 3 in the placebo group (P<.05). The difference between the 2 groups after the second provocation was highly significant (P<.001). The increase in airflow in response to treatment was roughly 20% in the blocker group compared with only about 10% in the placebo group, relative to an airflow rate (299 mL/s) measured after provocation on day 1. CONCLUSIONS: The blocker was significantly more effective than placebo and reduced the typical symptoms of allergic rhinitis in response to nasal challenge with allergen by nearly 60% (placebo reduced symptoms by 25%). The pollen blocker cream did not produce any adverse effects. Therefore, the efficacy of the investigational product can be rated as good.
Authors: Abdullah Ali; Marie Wahlgren; Birgitta Rembratt-Svensson; Ameena Daftani; Peter Falkman; Per Wollmer; Johan Engblom Journal: Drug Deliv Date: 2019-12 Impact factor: 6.419
Authors: Anna Eitenmüller; Lisa Piano; Myriam Böhm; Kija Shah-Hosseini; Andreas Glowania; Oliver Pfaar; Ralph Mösges; Ludger Klimek Journal: J Allergy (Cairo) Date: 2014-05-22