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

Last updated: October 23, 2014
Sponsor: Apotex Inc.
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Rhinitis, Allergic, Perennial

Treatment

N/A

Clinical Study ID

NCT02273817
CICE-NASU-05SB03-CE
  • Ages 18-65
  • All Genders

Study 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.

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).

Study Design

Total Participants: 580
Study Start date:
March 01, 2011
Estimated Completion Date:
August 31, 2011