Seasonal Allergic RhinitisPhase 3NCT02273817
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 Phase 3 study testing Ciclesonide nasal spray, 50 μg per actuation. in people with Seasonal Allergic Rhinitis, run by Apotex Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Ciclesonide nasal spray, 50 μg per actuation.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Aug 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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.
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- 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).
About this study
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
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
- Being tested
- Ciclesonide nasal spray, 50 μg per actuation.
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide nasal spray, 50 μg per actuation.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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Ciclesonide Nasal Spray (Apotex, Inc.) | Experimental | 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. Receives: Drug: Ciclesonide nasal spray, 50 μg per actuation. |
| Omnaris™ nasal spray | Active comparator | 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. Receives: Drug: Ciclesonide nasal spray, 50 μg per actuation. |
| Placebo | Placebo comparator | 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. Receives: Drug: Ciclesonide nasal spray, 50 μg per actuation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 months
Secondary outcomes (1)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apotex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273817
- Sponsor's protocol ID
- CICE-NASU-05SB03-CE
- Status last verified
- Feb 2012
- First submitted
- 14 Oct 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02273817
- Acronym / sponsor ID
- CICE-NASU-05SB03-CE
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Apotex Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ciclesonide Nasal Spray (Apotex, Inc.) | Experimental | Drug: Ciclesonide nasal spray, 50 μg per actuation.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 | Active comparator | Drug: Ciclesonide nasal spray, 50 μg per actuation.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 | Placebo comparator | Drug: Ciclesonide nasal spray, 50 μg per actuation.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Ciclesonide Nasal Spray (Apotex, Inc.), Omnaris™ nasal spray, Placebo |
Primary outcome
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).
1 secondary outcome
Treatment Of Seasonal Allergic Rhinitis
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciclesonide nasal spray, 50 μg per actuation. in people with Seasonal Allergic Rhinitis, run by Apotex Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Of Seasonal Allergic Rhinitis (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.