Phase
Condition
Allergy
Common Cold
Rhinitis, Allergic, Perennial
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
If female of childbearing potential, is not pregnant (confirmed by negative urinepregnancy test) or lactating and must have used reliable birth control measuresthroughout the study.
At least a 2-year reliable medical history consistent with SAR
Positive skin test within 12 months of screening to at least one seasonal allergenpresent in the geographical area
Capable of tolerating intranasal application of the IMP, willing and able to complywith the requirements of the protocol
No clinically significant findings in physical and nasal examinations, and medicalhistory.
A reflective TNSS of at least 6 (out of 12) in the 24 hours prior to placebo lead-invisit.
Successfully complete the placebo lead-in period.
Exclusion
Exclusion Criteria:
- Signs or symptoms of nasal polyps, deviated septum, or any other condition which, inthe opinion of the Investigator, could resulted in erroneous study data.
Undergo nasal surgery or had nasal trauma within 3 months of screening.
Active respiratory conditions or respiratory tract infection that require antibiotictreatment within 2 weeks of screening
Persistent allergic rhinitis (PAR) that does not require or not expected to requireactive PAR treatment during the study period.
Evidence of any unstable or clinically significant conditions that would place thesubject at increased risk of complications, interfere with study participation, orconfound any of the study objectives.
Presence or history of clinically significant conditions which in the opinion of theInvestigator would have compromised the safety of the subject or the conduct of thestudy.
Use of corticosteroids, intranasal cromolyn, Leukotriene inhibitors, long or shortacting antihistamines, intranasal or systemic decongestants prior to the start of thesingle-blind, placebo lead-in visit within the time periods specified in the protocolor receiving immunotherapy.
Use of an investigational drug within 30 days before screening or during the study.
Known or suspected hypersensitivity to corticosteroids.
Inability to avoid exposure to chicken pox or measles.
Infection requiring oral antibiotic treatment 2 weeks prior to screening.
Previously identified as a placebo responder or known as a non responder tocorticosteroids.
History of alcohol, drug, or substance abuse in the 12 months prior to Visit 1 (screening).
Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
Uncooperative or non compliant.
Female subjects who planned to become pregnant during the conduct of the study.
Current smoker (former smokers had to be 6 months smoke free).