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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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ciclesonide nasal spray, 50 μg per actuation.

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Ciclesonide Nasal Spray (Apotex, Inc.)

Omnaris™ nasal spray

Placebo

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02273817

First Posted

October 14, 2014

Last Updated

October 23, 2014

Sponsor

Apotex Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02273817

Brief Title

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

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Apotex Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

580 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ciclesonide Nasal Spray (Apotex, Inc.)

Arm Type

Experimental

Arm Description

Arm Title

Omnaris™ nasal spray

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ciclesonide nasal spray, 50 μg per actuation.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Treatment Of Seasonal Allergic Rhinitis

Description

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).

Time Frame

5 months

Secondary Outcome Measure Information:

Title

Treatment Of Seasonal Allergic Rhinitis

Description

Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing.

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

12. IPD Sharing Statement

Learn more about this trial

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

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