A Study Comparing The Bioequivalence Of Ciclesonide Nasal Spray (Apotex, Inc.) To That Of Omnaris™ Nasal Spray (Sepracor, Inc.) In The Treatment Of Seasonal Allergic Rhinitis

Launched by APOTEX INC. · Oct 23, 2014

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • If female of childbearing potential, is not pregnant (confirmed by negative urine pregnancy test) or lactating and must have used reliable birth control measures throughout 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 allergen present in the geographical area
• • Capable of tolerating intranasal application of the IMP, willing and able to comply with the requirements of the protocol
• • No clinically significant findings in physical and nasal examinations, and medical history.
• • A reflective TNSS of at least 6 (out of 12) in the 24 hours prior to placebo lead-in visit.
• • Successfully complete the placebo lead-in period.
• Exclusion Criteria:
• • - Signs or symptoms of nasal polyps, deviated septum, or any other condition which, in the 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 antibiotic treatment within 2 weeks of screening
• • Persistent allergic rhinitis (PAR) that does not require or not expected to require active PAR treatment during the study period.
• • Evidence of any unstable or clinically significant conditions that would place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.
• • Presence or history of clinically significant conditions which in the opinion of the Investigator would have compromised the safety of the subject or the conduct of the study.
• • Use of corticosteroids, intranasal cromolyn, Leukotriene inhibitors, long or short acting antihistamines, intranasal or systemic decongestants prior to the start of the single-blind, placebo lead-in visit within the time periods specified in the protocol or 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 to corticosteroids.
• • 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).