Jodi Frantz, MD

ABSTRACT

BACKGROUND: Symptoms resulting from early response to allergen exposure are histamine mediated, last a few minutes, and often cue patients to take medication. Hours later, the late response begins and typically leads to symptoms of congestion. The late-phase response is not histamine mediated; other studies have shown intranasal corticosteroids to inhibit the response. The researchers tested the hypothesis that intranasal steroids may be as beneficial as or superior to antihistamines for as-needed use because of their effect on the late response to environmental allergens.

POPULATION STUDIED: The 88 subjects, aged 18 to 48 years, had fall seasonal rhinitis for at least 2 ragweed seasons before enrollment and had a positive puncture skin test to ragweed antigen extract. The population was 52% male, 60% white and in general good health. Patients were excluded for nasal polyps, displaced septum, perennial rhinitis, and signs or symptoms of renal, hepatic, or cardiovascular disease. Patients were also excluded if they had received immunotherapy within 2 years before enrollment or had taken topical or systemic steroids, antihistamines, decongestants, or cromolyn sodium within 2 weeks before enrollment.

STUDY DESIGN AND VALIDITY: This is a randomized unblinded study. Patients were enrolled before or during the early part of the ragweed season. They were randomized to receive 100 μg/day fluticasone propionate per nostril or 10 mg loratadine once daily as needed for 4 weeks. Nasal lavage for eosinophil count and eosinophil cationic protein (ECP) and completion of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ, a validated instrument) were performed initially, at 2 weeks, and at 4 weeks. Patients were instructed to record medication usage and symptom severity in a diary twice daily. Itchy eyes and 3 symptoms for each nostril (rhinorrhea, nasal congestion, and sneezing) were rated on a scale of 0 to 3, ranging from 0 = no symptoms to 3 = severe symptoms.

OUTCOMES MEASURED: The RQLQ score was the primary outcome. The symptom diary scores were evaluated by symptom; a total symptom score was calculated. Other outcomes included nasal lavage eosinophil count and ECP levels.

RESULTS: Patients used medication an average of 17 of 28 days in the fluticasone group, similar to the average of 18 of 28 days in the loratadine group. The RQLQ scores were similar in the 2 groups initially. Significant improvement in the fluticasone group over the loratadine group was seen at the second and third visits in the overall score and activity, sleep, practical, and nasal domains of the RQLQ (P < .05). Symptom diaries showed a median score of 7.0 out of 21 for the loratadine-treated group and 4.0 out of 21 for the steroid-treated group (P = .005). Eosinophil count and ECP showed significant decreases in the steroid group.

ABSTRACT

BACKGROUND: Symptoms resulting from early response to allergen exposure are histamine mediated, last a few minutes, and often cue patients to take medication. Hours later, the late response begins and typically leads to symptoms of congestion. The late-phase response is not histamine mediated; other studies have shown intranasal corticosteroids to inhibit the response. The researchers tested the hypothesis that intranasal steroids may be as beneficial as or superior to antihistamines for as-needed use because of their effect on the late response to environmental allergens.

POPULATION STUDIED: The 88 subjects, aged 18 to 48 years, had fall seasonal rhinitis for at least 2 ragweed seasons before enrollment and had a positive puncture skin test to ragweed antigen extract. The population was 52% male, 60% white and in general good health. Patients were excluded for nasal polyps, displaced septum, perennial rhinitis, and signs or symptoms of renal, hepatic, or cardiovascular disease. Patients were also excluded if they had received immunotherapy within 2 years before enrollment or had taken topical or systemic steroids, antihistamines, decongestants, or cromolyn sodium within 2 weeks before enrollment.

STUDY DESIGN AND VALIDITY: This is a randomized unblinded study. Patients were enrolled before or during the early part of the ragweed season. They were randomized to receive 100 μg/day fluticasone propionate per nostril or 10 mg loratadine once daily as needed for 4 weeks. Nasal lavage for eosinophil count and eosinophil cationic protein (ECP) and completion of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ, a validated instrument) were performed initially, at 2 weeks, and at 4 weeks. Patients were instructed to record medication usage and symptom severity in a diary twice daily. Itchy eyes and 3 symptoms for each nostril (rhinorrhea, nasal congestion, and sneezing) were rated on a scale of 0 to 3, ranging from 0 = no symptoms to 3 = severe symptoms.

OUTCOMES MEASURED: The RQLQ score was the primary outcome. The symptom diary scores were evaluated by symptom; a total symptom score was calculated. Other outcomes included nasal lavage eosinophil count and ECP levels.

RESULTS: Patients used medication an average of 17 of 28 days in the fluticasone group, similar to the average of 18 of 28 days in the loratadine group. The RQLQ scores were similar in the 2 groups initially. Significant improvement in the fluticasone group over the loratadine group was seen at the second and third visits in the overall score and activity, sleep, practical, and nasal domains of the RQLQ (P < .05). Symptom diaries showed a median score of 7.0 out of 21 for the loratadine-treated group and 4.0 out of 21 for the steroid-treated group (P = .005). Eosinophil count and ECP showed significant decreases in the steroid group.

ABSTRACT

BACKGROUND: Symptoms resulting from early response to allergen exposure are histamine mediated, last a few minutes, and often cue patients to take medication. Hours later, the late response begins and typically leads to symptoms of congestion. The late-phase response is not histamine mediated; other studies have shown intranasal corticosteroids to inhibit the response. The researchers tested the hypothesis that intranasal steroids may be as beneficial as or superior to antihistamines for as-needed use because of their effect on the late response to environmental allergens.

POPULATION STUDIED: The 88 subjects, aged 18 to 48 years, had fall seasonal rhinitis for at least 2 ragweed seasons before enrollment and had a positive puncture skin test to ragweed antigen extract. The population was 52% male, 60% white and in general good health. Patients were excluded for nasal polyps, displaced septum, perennial rhinitis, and signs or symptoms of renal, hepatic, or cardiovascular disease. Patients were also excluded if they had received immunotherapy within 2 years before enrollment or had taken topical or systemic steroids, antihistamines, decongestants, or cromolyn sodium within 2 weeks before enrollment.

STUDY DESIGN AND VALIDITY: This is a randomized unblinded study. Patients were enrolled before or during the early part of the ragweed season. They were randomized to receive 100 μg/day fluticasone propionate per nostril or 10 mg loratadine once daily as needed for 4 weeks. Nasal lavage for eosinophil count and eosinophil cationic protein (ECP) and completion of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ, a validated instrument) were performed initially, at 2 weeks, and at 4 weeks. Patients were instructed to record medication usage and symptom severity in a diary twice daily. Itchy eyes and 3 symptoms for each nostril (rhinorrhea, nasal congestion, and sneezing) were rated on a scale of 0 to 3, ranging from 0 = no symptoms to 3 = severe symptoms.

OUTCOMES MEASURED: The RQLQ score was the primary outcome. The symptom diary scores were evaluated by symptom; a total symptom score was calculated. Other outcomes included nasal lavage eosinophil count and ECP levels.

RESULTS: Patients used medication an average of 17 of 28 days in the fluticasone group, similar to the average of 18 of 28 days in the loratadine group. The RQLQ scores were similar in the 2 groups initially. Significant improvement in the fluticasone group over the loratadine group was seen at the second and third visits in the overall score and activity, sleep, practical, and nasal domains of the RQLQ (P < .05). Symptom diaries showed a median score of 7.0 out of 21 for the loratadine-treated group and 4.0 out of 21 for the steroid-treated group (P = .005). Eosinophil count and ECP showed significant decreases in the steroid group.