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• W2128753355 abstract "RATIONALE: Though intranasal corticosteroids (INS) are first line treatment for seasonal allergic rhinitis (SAR), some patients do not respond adequately reflecting biological heterogeneity or confounding conditions. We sought to determine if failure of the nasal mucosa to decongest adequately with topical oxymetazoline identifies subjects with SAR who are less responsive to mometasone furoate (MF).METHODS: We performed a 2-week, double-blind, placebo-controlled, parallel study in 40 subjects with SAR who underwent a decongestant test which involved objective assessment of decongestion with NPIF before/after topical oxymetazoline. Baseline nasal symptoms, Nasal Peak Inspiratory Flow (NPIF) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores were recorded. Next, subjects were randomized to either 200μg MF or placebo. Symptom diaries and NPIF measurements were completed twice daily. RQLQ was repeated after 2 weeks.RESULTS: There was a significant reduction in symptoms in the MF group compared to placebo (p≤0.05) in subjects with baseline symptom score ≥6, but not with those with <6. MF was associated with a trend toward improvement in RQLQ sleep scores (p=0.08). Multivariate analysis showed that treatment (MF vs. placebo) (p=0.049) and amount of decongestion (% change in NPIF after oxymetazoline) (p=0.005) predicted the magnitude of the change in total nasal symptoms.CONCLUSIONS: To minimize heterogeneity in SAR clinical trials, entry criteria must ensure that subjects report multiple baseline symptoms (above a threshold) to be potentially responsive to INS therapy. Our results support the use of the decongestant test to choose appropriate study volunteers to ensure participation of potentially responsive subjects and eliminate those with confounding issues. RATIONALE: Though intranasal corticosteroids (INS) are first line treatment for seasonal allergic rhinitis (SAR), some patients do not respond adequately reflecting biological heterogeneity or confounding conditions. We sought to determine if failure of the nasal mucosa to decongest adequately with topical oxymetazoline identifies subjects with SAR who are less responsive to mometasone furoate (MF). METHODS: We performed a 2-week, double-blind, placebo-controlled, parallel study in 40 subjects with SAR who underwent a decongestant test which involved objective assessment of decongestion with NPIF before/after topical oxymetazoline. Baseline nasal symptoms, Nasal Peak Inspiratory Flow (NPIF) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores were recorded. Next, subjects were randomized to either 200μg MF or placebo. Symptom diaries and NPIF measurements were completed twice daily. RQLQ was repeated after 2 weeks. RESULTS: There was a significant reduction in symptoms in the MF group compared to placebo (p≤0.05) in subjects with baseline symptom score ≥6, but not with those with <6. MF was associated with a trend toward improvement in RQLQ sleep scores (p=0.08). Multivariate analysis showed that treatment (MF vs. placebo) (p=0.049) and amount of decongestion (% change in NPIF after oxymetazoline) (p=0.005) predicted the magnitude of the change in total nasal symptoms. CONCLUSIONS: To minimize heterogeneity in SAR clinical trials, entry criteria must ensure that subjects report multiple baseline symptoms (above a threshold) to be potentially responsive to INS therapy. Our results support the use of the decongestant test to choose appropriate study volunteers to ensure participation of potentially responsive subjects and eliminate those with confounding issues." @default.
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• W2128753355 date "2010-02-01" @default.
• W2128753355 modified "2023-10-15" @default.
• W2128753355 title "Recruitment Factors Which Affect the Outcome of a Seasonal Allergic Rhinitis Trial" @default.
• W2128753355 doi "https://doi.org/10.1016/j.jaci.2009.12.403" @default.
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