- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ciclesonide Nasal Spray (Apotex, Inc.)
Ciclesonide nasal spray
|
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:
|
Active Comparator: Omnaris™ nasal spray
Omnaris™ Nasal Spray,
|
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:
|
Placebo Comparator: Placebo
Placebo
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Of Seasonal Allergic Rhinitis
Time Frame: 5 months
|
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
Time Frame: 5 months
|
Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing.
|
5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Allergic Agents
- Ciclesonide
Other Study ID Numbers
- CICE-NASU-05SB03-CE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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