open-label, parallel-group study comparing the use of as-needed
intranasal Flonase vs. oral Claritin.1
· 88 patients with seasonal allergic rhinitis and positive
skin test to ragweed.
· Exclusion criteria: perennial rhinitis; cardiovascular
disease; nasal polyps; deviated nasal septum; use of corticosteroids,
antihistamines, decongestants, or cromolyn within 2 weeks; immunotherapy
within 2 years.
· Patients randomized to use either Flonase nasal spray
(100mcg each nostril) or Claritin (10mg po) on an as-needed basis.
· No rescue medications allowed.
· Patients were evaluated at start of study, 2 weeks, and
4 weeks. At each visit, they completed the Rhinoconjunctivitis
Quality of Life Questionnaire (RQLQ) and underwent nasal lavage
to measure total eosinophil count and eosinophil cationic protein
(ECP). Patients also recorded symptoms (rhinorrhea, congestion,
sneezing, itchy eyes on scale of 0 to 3) in a diary twice daily
throughout the study.
measures: RQLQ score, daily symptom diary scores, number of eosinophils
and level of ECP in nasal lavage samples.
In comparison to those taking Claritin, patients taking Flonase
· Better scores in the activity, sleep, practical, nasal,
and overall categories of the RQLQ (P < 0.05).
· Lower median total daily symptom scores (4.0 vs. 7.0,
P < 0.01).
· Fewer eosinophils and lower ECP levels in their nasal
lavages (P = 0.001).1
· Randomized clinical trial, groups similar at baseline,
· However, was not double-blinded and unclear if intention
to treat analysis used.
· No actual numbers provided for RQLQ scores.
· Only number provided for daily symptom scores was the
median total symptom score at day 28.
· Possibility of individual bias because patients were