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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Ciclesonide nasal spray, 50 μg per actuation.


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciclesonide Nasal Spray (Apotex, Inc.)<br>Ciclesonide nasal spray Dosage form: contain the aqueous medium of each metered-dose pump spray formulation unit plus the active ingredient, ciclesonide. Strength: 50 μg per actuation. Batch/Lot number (Expiry date): JM6697 (May 2012) Manufacturer: Apotex, Inc. | Drug: Ciclesonide nasal spray, 50 μg per actuation.<br>* During placebo lead-in period: patients received placebo nasal spray, two actuations in each nostril once daily for 7 days. During treatment period: subjects were then assigned to one of the following three treatments according to the randomization scheme: Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.<br>|
| Active Comparator: Omnaris™ nasal spray<br>Omnaris™ Nasal Spray, Dosage form: contain the aqueous medium of each metered-dose pump spray formulation unit plus the active ingredient, ciclesonide Strength: 50 μg per actuation Batch/Lot number (Expiry date): 131657 (03/2012) Manufacturer: Sepracor, Inc. | Drug: Ciclesonide nasal spray, 50 μg per actuation.<br>* During placebo lead-in period: patients received placebo nasal spray, two actuations in each nostril once daily for 7 days. During treatment period: subjects were then assigned to one of the following three treatments according to the randomization scheme: Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.<br>|
| Placebo Comparator: Placebo<br>Placebo Dosage form: Contain the aqueous medium of each metered-dose pump spray formulation unit minus the active ingredient, ciclesonide. Batch/Lot number (Expiry date): JR3808 (Nov 2012) Manufacturer: Apotex, Inc. | Drug: Ciclesonide nasal spray, 50 μg per actuation.<br>* During placebo lead-in period: patients received placebo nasal spray, two actuations in each nostril once daily for 7 days. During treatment period: subjects were then assigned to one of the following three treatments according to the randomization scheme: Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Of Seasonal Allergic Rhinitis | Change from baseline in the combined reflective Total nasal symptom score (TNSS) (combined AM and PM reflective scores of runny nose, nasal congestion, nasal itchiness, and sneezing). | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Of Seasonal Allergic Rhinitis | Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing. | 5 months |