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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic ciclesonide nasal spray compared with Omnaris™ nasal spray.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apotex Inc.
• Treatments: Ciclesonide

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).