Perennial Allergic RhinitisPhase 4NCT01654536
A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)
A Phase 4 study testing ciclesonide nasal aerosol and ciclesonide nasal spray in people with Perennial Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 31 sites in United States.
Trial summary
This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- ciclesonide nasal aerosol and ciclesonide nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 737 participants
- Where
- 31 sitesUnited States
- Study dates
- Sep 2012to Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject or Subject's parent/guardian gives written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Male or female 12 years and older, as of the Screening visit.
- Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history.
- A history of PAR to a relevant perennial allergen (eg, house dust mites, cockroach, molds, animal dander) for a minimum of one year immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past 12 months, and require treatment throughout the entire study period.
- Subject, if female ≤ 65 years of age, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
- An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
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- Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- Abstinence.
- Subject must possess an educational level and degree of understanding of English that enables them to communicate suitably with the PI and study coordinator.
Who cannot join
- Female subject who is pregnant or lactating.
- Current physical findings of nasal polyps, septal perforation, or nasal ulceration. (Subjects showing significant progression of nasal pathology between screening and randomization would be excluded at the discretion of the investigator.]
- Planned insertion of nasal septal jewelry during the study period.
- Surgery (including biopsy) and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 30 days prior to the Screening visit.
- Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
Show all 33Show fewer
- History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening visit.
- History of alcohol or drug abuse within 2 years preceding the Screening visit.
- History of a positive test for HIV, hepatitis B or hepatitis C.
- Active asthma requiring treatment with inhaled or systemic corticosteroids.
- Use of chronic treatment with agents known to promote the development of cataracts (potassium-sparing diuretics and allopurinol).
- Non vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
- Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
- Use of nasal corticosteroids within 14 days, or ocular, oral or parenteral within 6 months prior to randomization.
- Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial:
- impaired hepatic function including alcohol related liver disease or cirrhosis
- diabetes mellitus
- malignancy (excluding basal cell carcinoma)
- Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written Ocular Exclusion Criteria
- History of bacterial or viral infection of the eyes within 14 days of the Screening visit or current or history of ocular herpes simplex.
- Any use within 6 months prior to the randomization or planned use during the trial of a topical ocular corticosteroid, or intraocular or periocular injection of corticosteroids.
- Progressive retinal (including, but not limited to acute macular degeneration or unstable diabetic retinopathy) or optic nerve disease in either eye.
- Ocular injury/surgery in the last 6 months (including LASIK eye surgery, as well as any glaucoma intraocular surgery, including laser trabeculoplasty [ALT or SLT]).
- Any evidence of glaucomatous optic disc changes or a vertical cup:disc ratio > 0.8.
- Current or history of any glaucoma related diagnosis, including ocular hypertension, open-angle or closed-angle, as well as secondary or congenital glaucoma.
- Occludable angles by slit lamp examination (eg, peripheral anterior chamber less than or equal to one quarter of the peripheral corneal thickness), which may be confirmed by gonioscopy at the investigator's discretion..
- Current PSC cataract or previous history of cataract surgery.
- Current or history of congenital cataract or active or prior uveitis.
- Historical or current intraocular pressure of 22 mm Hg or higher in either eye.
- Inability to complete ocular examination, including: Inability to measure intraocular pressure, Pupillary diameter < 6 mm upon dilation , Significant media opacity in either eye that would exclude adequate posterior segment examination, Clinically significant corneal dystrophy, epithelial, or endothelial disease that would preclude visualization or intraocular pressure measurement, Corneal irregularities or scarring that in the investigator's judgment would impeded an accurate measurement of intraocular pressure or visualization of intraocular anatomy, Unwillingness to remove contact lenses for ocular examination, Subjects with LOCS III grade NO > 4.0, NC > 4.0 and C > 4.0 in either eye
- Best-corrected visual acuity in either eye of 20/200 or worse at the screening ocular examination.
- Planned or anticipated ocular surgery during the next 6 months.
- Any condition that, in the judgment of the ophthalmologist, would preclude the subject from completing the protocol with capture of the assessments as written.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Isis Clinical Research, LLC
Austin, Texas, 78731
Sirius Clinical Research LLC
Austin, Texas, 78759
Gordon D Raphael, MD
Bethesda, Maryland, 20814
Valley Clinical Research Center
Bethlehem, Pennsylvania, 18020
Clinical Research Group of Montanta
Bozeman, Montana, 59718
Ocean Allergy & Respiratory Research Center
Brick, New Jersey, 08724
National Allergy, Asthma & Uticaria Centers of Charleston, P.A.
Charleston, South Carolina, 29406
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
Pharmaceutical Research and Consulting Inc.
Dallas, Texas, 75231
Medical Education and Research Management Services of New England
Gardner, Massachusetts, 01440
Allergy and Asthma Center of NC, PA
High Point, North Carolina, 27262
Kerrville Research Associates, PA
Kerrville, Texas, 78028
DataQuest Medical Research LLC
Lawerenceville, Georgia, 30046
Asthma & Allergy Consultants, PC
Lilburn, Georgia, 30047
Clinical Research Institute Inc.
Minneappolis, Minnesota, 55402
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691
Central Texas Health Research
New Braunfels, Texas, 78130
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747
Atlantic Research Center, LLC
Ocean City, New Jersey, 07721
CHOC PSF AMC - Division of Allergy, Asthma and Immunology
Orange, California, 92868
Allergy Assocaites Research Center
Portland, Oregon, 97202
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Biogenics Research Institute
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy Associates Medical Group Inc.
San Diego, California, 92120
ASTHMA Inc. Clinical Research Center
Seattle, Washington, 98115
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Bensch Research Associates
Stockton, California, 95207
Asthma and Allergy Research Associates
Upland, Pennsylvania, 19013
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
About this study
Official title: A 6 Month Randomized, Open Label, Parallel Group, Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis
This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.
Read the detailed description
This is a 6 month, multicenter, randomized, open label, parallel group, safety study of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR. The objectives of this study are to evaluate the nasal and ocular safety of once daily dosing with ciclesonide nasal aerosol (Zetonna) 74 mcg and ciclesonide aqueous nasal spray (Omnaris) 200 mcg in subjects 12 years and older with PAR.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- ciclesonide nasal aerosol, ciclesonide nasal spray
- Keywords
- PAR
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclesonide nasal aerosolDrug
Also called Zetonna
ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)
ciclesonide nasal sprayDrug
Also called Omnaris
ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)
| Study group | Role | What they receive |
|---|---|---|
| ciclesonide nasal aerosol | Experimental | ciclesonide nasal aerosol 74 mcg Receives: Drug: ciclesonide nasal aerosol |
| ciclesonide nasal spray | Active comparator | ciclesonide nasal spray 200 mcg Receives: Drug: ciclesonide nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Measured: 0-6 months
The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Measured: 0-6 months
Secondary outcomes (14)
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Measured: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Measured: 0-6 months
The Number of Subjects Experiencing Treatment Emergent AEs.
Measured: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Measured: 0-6 months
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Measured: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Measured: 0-6 months
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Measured: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Measured: 0-6 months
Number of Subjects With Development of or Worsening in Lens Opacities.
Measured: 0-6 months
Percentage of Subjects With Development of or Worsening in Lens Opacities.
Measured: 0-6 months
Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Measured: 0-6 months
Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Measured: 0-6 months
Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Measured: 0-6 months
Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perennial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Respiratory Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654536
- Sponsor's protocol ID
- SEP060-401
- Status last verified
- Jul 2014
- First submitted
- 27 Jul 2012
- Last updated
- 24 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Month Randomized, Open Label, Parallel Group, Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01654536
- Acronym / sponsor ID
- SEP060-401
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- PAR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 24 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.
Detailed description
This is a 6 month, multicenter, randomized, open label, parallel group, safety study of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR. The objectives of this study are to evaluate the nasal and ocular safety of once daily dosing with ciclesonide nasal aerosol (Zetonna) 74 mcg and ciclesonide aqueous nasal spray (Omnaris) 200 mcg in subjects 12 years and older with PAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ciclesonide nasal aerosol | Experimental | Drug: ciclesonide nasal aerosolciclesonide nasal aerosol 74 mcg |
| ciclesonide nasal spray | Active comparator | Drug: ciclesonide nasal sprayciclesonide nasal spray 200 mcg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subject or Subject's parent/guardian gives written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Male or female 12 years and older, as of the Screening visit.
- Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history.
- A history of PAR to a relevant perennial allergen (eg, house dust mites, cockroach, molds, animal dander) for a minimum of one year immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past 12 months, and require treatment throughout the entire study period.
- Subject, if female ≤ 65 years of age, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
Key exclusion criteria (33 listed)
- Female subject who is pregnant or lactating.
- Current physical findings of nasal polyps, septal perforation, or nasal ulceration. (Subjects showing significant progression of nasal pathology between screening and randomization would be excluded at the discretion of the investigator.]
- Planned insertion of nasal septal jewelry during the study period.
- Surgery (including biopsy) and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 30 days prior to the Screening visit.
- Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
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 aerosolAlso: Zetonnaciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol) | Drug | ciclesonide nasal aerosol |
| ciclesonide nasal sprayAlso: Omnarisciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray) | Drug | ciclesonide nasal spray |
Primary outcome
The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Time frame: 0-6 months
The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Time frame: 0-6 months
14 secondary outcomes
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Time frame: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Time frame: 0-6 months
The Number of Subjects Experiencing Treatment Emergent AEs.
Time frame: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Time frame: 0-6 months
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Time frame: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Time frame: 0-6 months
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Time frame: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Time frame: 0-6 months
Number of Subjects With Development of or Worsening in Lens Opacities.
Time frame: 0-6 months
Percentage of Subjects With Development of or Worsening in Lens Opacities.
Time frame: 0-6 months
Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Time frame: 0-6 months
Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Time frame: 0-6 months
Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Time frame: 0-6 months
Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Time frame: 0-6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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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.
Respiratory Medical Director, MD study director
Sumitomo Pharma America, Inc.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ciclesonide nasal aerosol and ciclesonide nasal spray in people with Perennial Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 31 sites in United States.
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 9 inclusion and 33 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) (time frame: 0-6 months). The study lists 2 primary outcomes in all. 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 Jul 2014.