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

NCT ID: NCT02273817

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 580 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-08-31

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ciclesonide Nasal Spray (Apotex, Inc.)

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.

Group Type: EXPERIMENTAL

Ciclesonide nasal spray, 50 μg per actuation.

Intervention Type: DRUG

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:

1. Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.

2. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.

3. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.

Omnaris™ nasal spray

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.

Group Type: ACTIVE_COMPARATOR

Ciclesonide nasal spray, 50 μg per actuation.

Intervention Type: DRUG

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:

1. Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.

2. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.

3. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Ciclesonide nasal spray, 50 μg per actuation.

Intervention Type: DRUG

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:

1. Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.

2. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.

3. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.

Interventions

Ciclesonide nasal spray, 50 μg per actuation.

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:

1. Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.

2. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.

3. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apotex Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CICE-NASU-05SB03-CE

Identifier Type: -

Identifier Source: org_study_id