36022
document
Onset of action of ciclesonide once daily in the treatment of seasonal allergic rhinitis . Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis . We conducted a randomized , double-blind , parallel-group , placebo-controlled study to evaluate the time to onset of action of ciclesonide 200 microg once daily in 502 adults with seasonal allergic rhinitis of at least 2 years ' duration . To trigger immunologic priming , patients underwent between one and five priming sessions with exposure to 3,500 grains/m ( 3 ) ( +/-500 ) of ragweed pollen in an environmental exposure chamber . The criteria for a successful priming session were a patient-assessed instantaneous total nasal symptom score of at least 6 ( of a possible 12 ) and a nasal congestion or rhinorrhea score of at least 2 ( of a possible 3 ) 90 minutes after allergen exposure during at least two consecutive priming sessions . Patients were then randomly assigned to receive either a single dose of ciclesonide 200 microg ( n = 251 ) or placebo ( n = 251 ) administered intranasally . The difference in the change from baseline total nasal symptom scores in the two groups was assessed hourly for 12 hours after administration . Onset of action was determined to have taken place the first time that the effects of ciclesonide , as reflected in the total nasal symptom score , were significantly greater than those of placebo at a particular hourly assessment , provided that the subsequent hourly assessment also showed a statistically significant difference . The onset of action of ciclesonide occurred within 1 hour of administration ( p = 0.01 vs. placebo ) , and the significant difference in total nasal symptom scores between ciclesonide and placebo was maintained through post-treatment hour 12 ( p = 0.018 ) .
36023
Intervention_Pharmacological
ciclesonide
36024
Intervention_Pharmacological
Ciclesonide
36025
Intervention_Pharmacological
ciclesonide
36026
Intervention_Pharmacological
3,500 grains/m ( 3 ) ( +/-500 ) of ragweed pollen
36027
Intervention_Pharmacological
ciclesonide
36028
Intervention_Control
placebo
36029
Intervention_Pharmacological
ciclesonide
36030
Intervention_Control
placebo
36031
Intervention_Pharmacological
ciclesonide
36032
Intervention_Pharmacological
ciclesonide
36033
Intervention_Control
placebo
36034
Outcome_Other
Onset of action
36035
Outcome_Physical
total nasal symptom score
36036
Outcome_Physical
nasal congestion or rhinorrhea score
36037
Outcome_Physical
baseline total nasal symptom scores
36038
Outcome_Other
Onset of action
36039
Outcome_Physical
total nasal symptom score
36040
Outcome_Other
onset of action of ciclesonide
36041
Outcome_Physical
total nasal symptom scores
36042
Participant_Sample-size
502
36043
Participant_Condition
seasonal allergic rhinitis