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

Apotex

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Ciclesonide nasal spray, 50 μg per actuation.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02273817

CICE-NASU-05SB03-CE

Details and patient eligibility

About

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.

Enrollment: 580 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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580 participants in 3 patient groups, including a placebo group

Ciclesonide Nasal Spray (Apotex, Inc.)

Experimental group

Description:

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.

Treatment:

Drug: Ciclesonide nasal spray, 50 μg per actuation.

Omnaris™ nasal spray

Active Comparator group

Description:

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.

Treatment:

Drug: Ciclesonide nasal spray, 50 μg per actuation.

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ciclesonide nasal spray, 50 μg per actuation.