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document
Double-blind , placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device . BACKGROUND A proof-of-concept study suggested that combination therapy with commercial azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptoms of seasonal allergic rhinitis compared with either agent alone . OBJECTIVE To compare an azelastine-fluticasone combination nasal spray administered in a single-delivery device with a commercially available azelastine nasal spray and fluticasone nasal spray . METHODS This 14-day , multicenter , randomized , double-blind study was conducted during the Texas mountain cedar season . After a 5-day placebo lead-in , 610 patients with moderate-to-severe nasal symptoms were randomized to treatment with ( 1 ) azelastine nasal spray , ( 2 ) fluticasone nasal spray , ( 3 ) combination azelastine and fluticasone nasal spray , or ( 4 ) placebo nasal spray . All treatments were given as 1 spray per nostril twice daily . The primary efficacy variable was the change from baseline in the total nasal symptom score ( TNSS ) , consisting of nasal congestion , runny nose , itchy nose , and sneezing . RESULTS All 3 active groups were statistically superior ( P < or= .02 ) to placebo , and the combination was statistically superior ( P < or= .003 ) to either agent alone . The TNSS improved by 28.4 % with combination azelastine-fluticasone , 20.4 % with fluticasone , 16.4 % with azelastine , and 11.2 % with placebo . All 3 treatments were well tolerated . CONCLUSIONS The combination azelastine-fluticasone nasal spray provided statistically significant improvement in the TNSS and additive clinical benefit compared with either agent alone in patients with moderate-to-severe seasonal allergic rhinitis . TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00660517 .
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Intervention_Pharmacological
azelastine and fluticasone
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Intervention_Pharmacological
azelastine hydrochloride
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Intervention_Pharmacological
fluticasone propionate
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Intervention_Pharmacological
azelastine-fluticasone
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Intervention_Control
placebo
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Intervention_Pharmacological
( 1 ) azelastine nasal spray , ( 2 ) fluticasone nasal spray , ( 3 ) combination azelastine and fluticasone nasal spray , or ( 4 ) placebo nasal spray
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Intervention_Pharmacological
1 spray per nostril twice daily
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Intervention_Pharmacological
azelastine-fluticasone
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Intervention_Pharmacological
fluticasone
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Intervention_Pharmacological
azelastine
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Intervention_Control
placebo .
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Intervention_Pharmacological
azelastine-fluticasone
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Outcome_Physical
nasal symptoms of seasonal allergic rhinitis
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Outcome_Physical
total nasal symptom score ( TNSS )
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Outcome_Physical
nasal congestion , runny nose , itchy nose , and sneezing
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Outcome_Physical
TNSS
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Outcome_Physical
TNSS
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Participant_Condition
allergic rhinitis
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Participant_Sample-size
610 patients
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Participant_Condition
moderate-to-severe nasal symptoms
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Participant_Condition
moderate-to-severe seasonal allergic rhinitis