Perennial Allergic RhinitisPhase 3NCT01378429
Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis
A Phase 3 study testing ciclesonide nasal aerosol in people with Perennial Allergic Rhinitis and PAR, run by Sumitomo Pharma America, Inc. at 7 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Perennial Allergic Rhinitis, PAR
- What is being tested?
- ciclesonide nasal aerosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2011to Nov 2011
- Phase
- Phase 3
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gives written informed consent (parent/legal guardian) and assent (when appropriate, from the child), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Is a male or premenarchal female 6 to 11 years old and ≥ 20 kg at the screening visit.
- Is in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical examination and medical history.
- Has a history of PAR to a relevant perennial allergen (house dust mites, cockroaches, 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 and require treatment throughout the entire study period.
- Has a demonstrated sensitivity to at least one allergen known to induce PAR (house dust mites, cockroaches, molds, and animal dander) based on a documented result with a standard skin-prick test either within one year prior to the screening visit or performed at the screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin-prick test. The subject's positive allergen test must be consistent with the medical history of of PAR, and the allergen must be present in the subject's environment throughout the study.
Who cannot join
- Has a history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the 120 days prior to the screening visit.
- Has evidence of infection, significant anatomic abnormality, ulceration of the mucosa, blood in the nose, or any other clinically relevant finding on nasal examination at the screening visit.
- Has nasal jewelry.
- Has participated in any investigational drug trial within the 30 days preceding the screening visit or is planning participation in another investigational drug trial at any time during this trial.
- Has a known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
- Has a history of a respiratory infection or disorder, including but not limited to bronchitis, pneumonia, influenza, and severe acute respiratory syndrome (SARS), within the 14 days preceding the screening visit.
Show all 25Show fewer
- Has a history of adrenal insufficiency.
- Has active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drugs (eg, theophylline, leukotriene antagonists); intermittent use (≤ 3 uses per week) of inhaled short-acting beta-agonists is acceptable. Use of short-acting beta-agonists for exercise-induced bronchospasm will be allowed.
- Is expecting to use any disallowed concomitant medications during the treatment period.
- Is, in the investigator's judgment, having a seasonal exacerbation at the time of the screening visit.
- Is planning initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the screening visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
- Has nonvaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the screening visit.
- Initiates pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or plans a 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.
- Has experienced significant blood loss within 60 days or loss of plasma within 72 hours prior to the screening visit or intends to undergo elective surgery within 30 days following end of study.
- Is a child or immediate relative of any clinical investigator or site personnel, even those who are not directly involved in this study.
- Resides in the same household as another subject who is participating in this study at the same time.
- Has any of the following conditions that are judged by the investigator to be clinically significant and/or to affect the subject's ability to participate in the clinical trial:
- impaired hepatic function
- history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts or herpes simplex
- any systemic infection
- hematological (including anemia), hepatic, renal, endocrine disease
- gastrointestinal disease
- malignancy (excluding basal cell carcinoma)
- current neuropsychological condition with or without drug therapy. Any behavioral condition that could affect subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism.
- Has any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
West Coast Clinical Trials
Costa Mesa, California, 92626
Western Sky Medical Research
El Paso, Texas, 79903
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761
Clinical Research Institute
Plymouth, Minnesota, 55441
Sylvania Research Associates
San Antonio, Texas, 78229
Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
Official title: A 6-Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
The study requires that subjects be domiciled during two 24- to 36-hour time periods for sample collection for serum and urinary free cortisol measurements, as well as PK evaluations (single [predose] time point during the first domiciled period, and 24-hour sampling during the second domiciled period).
- Conditions
- Perennial Allergic Rhinitis, PAR
- Being tested
- ciclesonide nasal aerosol, Placebo
- Keywords
- Perennial Allergic Rhinitis, 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
ciclesonide nasal aerosol (74 mcg)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ciclesonide nasal aerosol | Experimental | ciclesonide nasal aerosol (74 mcg) Receives: Drug: ciclesonide nasal aerosol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period
Area under the concentration-time curve from time 0 to 24 hours [AUC(0-24h)]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.
Measured: Week 0 and 6
Secondary outcomes (16)
Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine
Measured: weeks 0-6
Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine
Measured: weeks 0-6
Number of Subjects Experiencing AEs
Measured: weeks 0-6
Percentage of Subjects Experiencing AEs
Measured: weeks 0-6
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Local Treatment-Emergent Adverse Events (ITT Population)
Measured: weeks 0-6
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Local Treatment-Emergent Adverse Events (ITT Population)
Measured: weeks 0-6
AUC(0-24h)
Area under the concentration-time curve from time 0 to 24 hours. Collected at 0, 30 min, 60 min, 90 min, 2 hours (h), 4 h, 8 h, 12 h, 16 h, and 24h after dosing.
Measured: Week 6
Maximum Observed Concentration
Cmax (ng/mL) (PK Population)
Measured: Week 6
Time to the Occurrence of Cmax
tmax (hour) (PK Population)
Measured: Week 6
Terminal Half Life (t1/2)
Terminal half-life (t1/2) (hour)
Measured: Weeks 6
Apparent Clearance of the Drug (CL/F)
CL/F liter per hour (L/hour) is the apparent clearance of the drug
Measured: Week 6
Apparent Volume of Distribution (Vz/F)
Vz/F Liters (L) is the apparent volume of distribution
Measured: Week 6
Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations
Measured: weeks 0-6
Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
Measured: weeks 0-6
Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
Measured: weeks 0-6
Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement
Measured: weeks 0-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionNov 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378429
- Sponsor's protocol ID
- 060-308
- Status last verified
- Apr 2014
- First submitted
- 20 Jun 2011
- Last updated
- 26 May 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 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR)
- ClinicalTrials.gov ID
- NCT01378429
- Acronym / sponsor ID
- 060-308
- Conditions
- Perennial Allergic Rhinitis, PAR
- Keywords
- Perennial Allergic Rhinitis, PAR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Posted 26 May 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 multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
The study requires that subjects be domiciled during two 24- to 36-hour time periods for sample collection for serum and urinary free cortisol measurements, as well as PK evaluations (single [predose] time point during the first domiciled period, and 24-hour sampling during the second domiciled period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ciclesonide nasal aerosol | Experimental | Drug: ciclesonide nasal aerosolciclesonide nasal aerosol (74 mcg) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gives written informed consent (parent/legal guardian) and assent (when appropriate, from the child), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Is a male or premenarchal female 6 to 11 years old and ≥ 20 kg at the screening visit.
- Is in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical examination and medical history.
- Has a history of PAR to a relevant perennial allergen (house dust mites, cockroaches, 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 and require treatment throughout the entire study period.
- Has a demonstrated sensitivity to at least one allergen known to induce PAR (house dust mites, cockroaches, molds, and animal dander) based on a documented result with a standard skin-prick test either within one year prior to the screening visit or performed at the screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin-prick test. The subject's positive allergen test must be consistent with the medical history of of PAR, and the allergen must be present in the subject's environment throughout the study.
Key exclusion criteria (25 listed)
- Has a history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the 120 days prior to the screening visit.
- Has evidence of infection, significant anatomic abnormality, ulceration of the mucosa, blood in the nose, or any other clinically relevant finding on nasal examination at the screening visit.
- Has nasal jewelry.
- Has participated in any investigational drug trial within the 30 days preceding the screening visit or is planning participation in another investigational drug trial at any time during this trial.
- Has a known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
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 aerosolciclesonide nasal aerosol (74 mcg) | Drug | ciclesonide nasal aerosol |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period
Time frame: Week 0 and 6
Area under the concentration-time curve from time 0 to 24 hours [AUC(0-24h)]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.
16 secondary outcomes
Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine
Time frame: weeks 0-6
Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine
Time frame: weeks 0-6
Number of Subjects Experiencing AEs
Time frame: weeks 0-6
Percentage of Subjects Experiencing AEs
Time frame: weeks 0-6
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Time frame: weeks 0-6
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Time frame: weeks 0-6
AUC(0-24h)
Time frame: Week 6
Maximum Observed Concentration
Time frame: Week 6
Time to the Occurrence of Cmax
Time frame: Week 6
Terminal Half Life (t1/2)
Time frame: Weeks 6
Apparent Clearance of the Drug (CL/F)
Time frame: Week 6
Apparent Volume of Distribution (Vz/F)
Time frame: Week 6
Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations
Time frame: weeks 0-6
Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
Time frame: weeks 0-6
Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
Time frame: weeks 0-6
Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: weeks 0-6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ciclesonide nasal aerosol in people with Perennial Allergic Rhinitis and PAR, run by Sumitomo Pharma America, Inc. at 7 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 5 inclusion and 25 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Yes. Results are posted in the registry (first posted 26 May 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 Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period (time frame: Week 0 and 6). 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 26 May 2014.