Clinical trial NCT02273817: 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
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Comparing the Bioquivalence of Ciclesonide Nasal Spray(Apotex Inc.) to That of Omnaris ™Nasal Spray (Sepracor, Inc.) in the Treatment of Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Apotex Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 safety and tolerability of generic ciclesonide nasal spray compared with Omnaris™ nasal spray.


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).

Primary outcomes:
measure: Treatment Of Seasonal Allergic Rhinitis
timeFrame: 5 months
Secondary outcomes:
measure: Treatment Of Seasonal Allergic Rhinitis
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
References: