Rhinitis, Allergic, PerennialPhase 3NCT00658918
To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)
A Phase 3 study testing Ciclesonide nasal in people with Rhinitis, Allergic, Perennial and Hay Fever, run by AstraZeneca at 1 site in United States.
Trial summary
The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with PAR. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial, Hay Fever
- What is being tested?
- Ciclesonide nasal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Nov 2005
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female between the ages of 2 and 5 years, inclusive
- General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial
- A demonstrated sensitivity to at least one allergen known to induce PAR through a standard prick skin test within one year of study start. A positive test is defined as a wheal diameter at least 3mm larger than the control wheal for th eprick test
- Parent or legal guardian is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)
- A history of PAR for a minimum of 3 months preceding the study screening visit (B0). The PAR must have been of sufficient severity to require treatment (either continuous or intermittent) in the past and in the investigators judgment is expected to continue to require treatment for the study duration.
Who cannot join
- History of physical findings of nasal pathology, including nasal polyps (within the last 60 days) or other clinically significant respiratory tract malformations, recent nasal biopsy (within the last 60 days), nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days).
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) or at any time during the trial
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation.
- History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit, or development of a respiratory infection during the Screening Visit (B0)
- History of a positive test for HIV, hepatitis B or hepatitis C.
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists and any controller drugs (e.g. theophylline, leukotrienes, etc.) intermittent use of b-agonists is acceptable
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- Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the screening visit (B0) and during the entire screening period and treatment duration
- Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0).
- 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.
- Non-vaccinated exposure to, or infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).
- Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g.: contact dermatitis), during the past 2 months, or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
- Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone for dermatological conditions during the past 1 month, or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study.
- Intraocular pressure at the screening visit (B0) of 21 mm Hg or greater or failed reading at the screening Visit (B0)
- Glaucoma requiring treatment
- Use of antiepileptic drugs for epilepsy within 30 days of the screening visit (B0) or anytime during the treatment period.
- Initiation of pimecrolimus 1% cream or tacrolimus ointment 0.1% or 0.03% during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to the screening Visit (B0) AND use of a stable (maintenance) dose during the study period may be considered for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Clinical Trial Designed to Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, 200µg, 100µg or 25µg Once Daily for Six Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age.
The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure serum concentrations of ciclesonide and its active metabolite under steady state conditions at three time points corresponding to the presumed peak and trough exposure after six weeks of administration.
In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were summarized.
- Conditions
- Rhinitis, Allergic, Perennial, Hay Fever
- Being tested
- Ciclesonide nasal, Placebo
- Keywords
- Perennial Allergic Rhinitis, Ciclesonide, Hay Fever, PAR
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide nasalDrug
safety of Ciclesonide (200µg, 100µg, 25µg)
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ciclesonide 200µg Receives: Drug: Ciclesonide nasal |
| 2 | Active comparator | Ciclesonide 100µg Receives: Drug: Ciclesonide nasal |
| 3 | Active comparator | Ciclesonide 25µg Receives: Drug: Ciclesonide nasal |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous and elicited adverse events (AEs)
Measured: 6 weeks
Vital signs
Measured: 6 weeks
Cortisol (24-hour urine. AM plasma)
Measured: 6 weeks
clinical laboratory parameters
Measured: 6 weeks
Physical examination including ENT exam
Measured: 6 weeks
Intraocular pressure (IOP) assessment
Measured: 6 weeks
serum concentrations of ciclesonide and its active metabolite will be measured following 6 weeks treatment at three time points corresponding to presumed peak and trough exposure
Measured: 6 weeks
Secondary outcomes (2)
reflective (24-hour) total nasal symptom score (TNSS; including sneezing, runny nose, nasal itching and congestion) over 6 weeks of treatment and over other selected time points
Measured: 6 weeks
a physician assessment of nasal symptoms at endpoint and at Visits T0, T3 and T6
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startSep 2004
- Primary completionApr 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658918
- Sponsor's protocol ID
- BY9010/M1-405
- Status last verified
- Oct 2016
- First submitted
- 14 Apr 2008
- Last updated
- 2 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Clinical Trial Designed to Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, 200µg, 100µg or 25µg Once Daily for Six Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age.
- ClinicalTrials.gov ID
- NCT00658918
- Acronym / sponsor ID
- BY9010/M1-405
- Conditions
- Rhinitis, Allergic, Perennial, Hay Fever
- Keywords
- Perennial Allergic Rhinitis, Ciclesonide, Hay Fever, PAR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 16 Apr 2008 (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.
The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure serum concentrations of ciclesonide and its active metabolite under steady state conditions at three time points corresponding to the presumed peak and trough exposure after six weeks of administration.
In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were summarized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ciclesonide nasalCiclesonide 200µg |
| 2 | Active comparator | Drug: Ciclesonide nasalCiclesonide 100µg |
| 3 | Active comparator | Drug: Ciclesonide nasalCiclesonide 25µg |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female between the ages of 2 and 5 years, inclusive
- General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial
- A demonstrated sensitivity to at least one allergen known to induce PAR through a standard prick skin test within one year of study start. A positive test is defined as a wheal diameter at least 3mm larger than the control wheal for th eprick test
- Parent or legal guardian is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)
- A history of PAR for a minimum of 3 months preceding the study screening visit (B0). The PAR must have been of sufficient severity to require treatment (either continuous or intermittent) in the past and in the investigators judgment is expected to continue to require treatment for the study duration.
Key exclusion criteria (16 listed)
- History of physical findings of nasal pathology, including nasal polyps (within the last 60 days) or other clinically significant respiratory tract malformations, recent nasal biopsy (within the last 60 days), nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days).
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) or at any time during the trial
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation.
- History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit, or development of a respiratory infection during the Screening Visit (B0)
- History of a positive test for HIV, hepatitis B or hepatitis C.
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 nasalsafety of Ciclesonide (200µg, 100µg, 25µg) | Drug | 1, 2, 3 |
| Placeboplacebo | Drug | 4 |
Primary outcome
Spontaneous and elicited adverse events (AEs)
Time frame: 6 weeks
Vital signs
Time frame: 6 weeks
Cortisol (24-hour urine. AM plasma)
Time frame: 6 weeks
clinical laboratory parameters
Time frame: 6 weeks
Physical examination including ENT exam
Time frame: 6 weeks
Intraocular pressure (IOP) assessment
Time frame: 6 weeks
serum concentrations of ciclesonide and its active metabolite will be measured following 6 weeks treatment at three time points corresponding to presumed peak and trough exposure
Time frame: 6 weeks
2 secondary outcomes
reflective (24-hour) total nasal symptom score (TNSS; including sneezing, runny nose, nasal itching and congestion) over 6 weeks of treatment and over other selected time points
Time frame: 6 weeks
a physician assessment of nasal symptoms at endpoint and at Visits T0, T3 and T6
Time frame: 6 weeks
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 2 Dec 2016.
- BY9010-M1-405-RDS-2005-11-07.pdfLink provided by the sponsor.
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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.
AstraZeneca AstraZeneca study director
AstraZeneca
1 site 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 in people with Rhinitis, Allergic, Perennial and Hay Fever, run by AstraZeneca at 1 site 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 16 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 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Spontaneous and elicited adverse events (AEs) (time frame: 6 weeks). The study lists 7 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 2 Dec 2016.