A Phase 2 interventional study of Ciclesonide HFA and Ciclesonide HFA in Rhinitis, Allergic, Seasonal, sponsored by AstraZeneca. Completed at 31 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA, applied as a nasal aerosol once daily, in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 480 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ciclesonide HFA 75 mcg (37,5 mcg / actuation, 1 actuation/nostril), once daily
Drug: Ciclesonide HFA
Ciclesonide HFA 150 mcg (75 mcg / actuation, 1 actuation/nostril), once daily
Drug: Ciclesonide HFA
Ciclesonide HFA 300 mcg (150 mcg / actuation, 1 actuation/nostril), once daily
Drug: Ciclesonide HFA
Placebo
Drug: Placebo
75 mcg Ciclesonide HFA versus Placebo
150 mcg Ciclesonide HFA versus Placebo
300 mcg Ciclesonide HFA versus Placebo
Placebo
Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment
Time frame: 2 weeks
Average of AM and PM patient-reported instantaneous TNSS over the first two weeks of treatment
Time frame: 2 weeks
Physician-assessed total nasal symptoms score (PNSS) over the treatment period
Time frame: 4 weeks
Rhinoconjunctivitis Quality of Life Questionaire (RQLQ) over the treatment period in patients (adolescents and adults) with impaired quality of life at Baseline defined as a RQLQ score of greater than 3.0
Time frame: 4 weeks
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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AstraZeneca