Status:
COMPLETED
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
Lead Sponsor:
Apotex Inc.
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- \- 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).
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT02273817
Start Date
March 1 2011
End Date
August 1 2011
Last Update
October 24 2014
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