Perennial Allergic RhinitisPhase 3NCT00163514
Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
A Phase 3 study testing Ciclesonide in people with Perennial Allergic Rhinitis and Allergic Rhinitis, run by AstraZeneca at 74 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
- What is being tested?
- Ciclesonide
- How many people
- 636 participants
- Where
- 74 sitesin 2 countries
- Study dates
- May 2004to Jul 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Main Inclusion Criteria:
- General good health, other than perennial allergic rhinitis
- History and diagnosis of perennial allergic rhinitis by skin prick test
- Parent/caregiver must be 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.)
Main Exclusion Criteria:
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial
- Use of any prohibited concomitant medications as defined by the study protocol
- Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit
Trial locations and contacts
74 sites in 2 countries.
74 sites in 2 countries
United States58 sites
Altana Pharma/Nycomed
Atlanta, Georgia, 30342
Altana Pharma/Nycomed
Austin, Texas, 78750
Altana Pharma/Nycomed
Brick, New Jersey, 08724
Altana Pharma/Nycomed
Burke, Virginia, 22015
Altana Pharma/Nycomed
Canton, Ohio, 44718
Altana Pharma/Nycomed
Charleston, South Carolina, 29407
Altana Pharma/Nycomed
Charleston, South Carolina, 29414
Altana Pharma/Nycomed
Cincinnati, OH, Ohio, 45231
Altana Pharma/Nycomed
Coral Gables, Florida, 33134
Altana Pharma/Nycomed
Dubuque, Iowa, 52001
Altana Pharma/Nycomed
Easton, Pennsylvania, 18045
Altana Pharma/Nycomed
El Paso, Texas, 79925
Altana Pharma/Nycomed
Fort Worth, Texas, 76132
Altana Pharma/Nycomed
Friendswood, Texas, 77546
Altana Pharma/Nycomed
Gainesville, Georgia, 30501
Altana Pharma/Nycomed
Hershey, Pennsylvania, 17033
Altana Pharma/Nycomed
Houston, Texas, 77054
Altana Pharma/Nycomed
Huntington Beach, California, 92647
Altana Pharma/Nycomed
Indianapolis, Indiana, 46208
Altana Pharma/Nycomed
Jefferson City, Missouri, 65101
Altana Pharma/Nycomed
Katy, Texas, 77450
Altana Pharma/Nycomed
Liverpool, New York, 13088
Altana Pharma/Nycomed
Medford, Oregon, 97504
Altana Pharma/Nycomed
Metairie, Louisiana, 70001
Altana Pharma/Nycomed
Minneapolis, Minnesota, 55402
Altana Pharma/Nycomed
Mission Viejo, California, 92691
Altana Pharma/Nycomed
Moncks Corner, South Carolina, 29461
Altana Pharma/Nycomed
Newport Beach, California, CA 92660
Altana Pharma/Nycomed
Normal, Illinois, 61761
Altana Pharma/Nycomed
North Dartmouth, Massachusetts, 02747
Altana Pharma/Nycomed
Ocala, Florida, 34471
Altana Pharma/Nycomed
Orange, California, 92868
Altana Pharma/Nycomed
Overland Park, Kansas, 66210
Altana Pharma/Nycomed
Oxford, Alabama, 36203
Altana Pharma/Nycomed
Palmdale, California, 93551
Altana Pharma/Nycomed
Papillion, Nebraska, 68046
Altana Pharma/Nycomed
Portland, Oregon, 97213
Altana Pharma/Nycomed
Raleigh, North Carolina, 27607
Altana Pharma/Nycomed
Richmond, Virginia, 23219
Altana Pharma/Nycomed
Richmond, Virginia, 23226
Altana Pharma/Nycomed
Rockville, Maryland, 20850
Altana Pharma/Nycomed
Rolla, Mo, Missouri, 65401
Altana Pharma/Nycomed
Salt Lake City, Utah, 84037
Altana Pharma/Nycomed
San Diego, California, 92120
Altana Pharma/Nycomed
San Diego, California, 92123
Altana Pharma/Nycomed
San Jose, California, 95117
Altana Pharma/Nycomed
Savannah, Georgia, 31406
Altana Pharma/Nycomed
Shreveport, Louisiana, 71130
Altana Pharma/Nycomed
Skillman, New Jersey, 08558
Altana Pharma/Nycomed
South Burlington, Vermont, 05403
Altana Pharma/Nycomed
Spartanburg, South Carolina, 29307
Altana Pharma/Nycomed
Spokane, Washington, 99202
Altana Pharma/Nycomed
St Louis, Missouri, 63141
Altana Pharma/Nycomed
Stockton, California, 95207
Altana Pharma/Nycomed
Sylvania, Ohio, 43560
Altana Pharma/Nycomed
Upland, Pennsylvania, 19013
Altana Pharma/Nycomed
Walnut Creek, CA, California, 94598
Altana Pharma/Nycomed
Wheaton, Maryland, 20902
Canada16 sites
Altana Pharma/Nycomed
Hamilton, L8N 3Z5
Altana Pharma/Nycomed
Hamilton, on, L8N 1Y2
Altana Pharma/Nycomed
Kanata, on, K2L 3C8
Altana Pharma/Nycomed
London, N6C 4Y7
Altana Pharma/Nycomed
London,ON, N6A1V2
Altana Pharma/Nycomed
Mississauga, L5B 1N1
Altana Pharma/Nycomed
Montreal, QC, H3T 1C5
Altana Pharma/Nycomed
Niagara Falls, L2G 1J4
Altana Pharma/Nycomed
Oshawa, on, L1H1B9
Altana Pharma/Nycomed
Ottawa, K1Y 4G2
Altana Pharma/Nycomed
Ottawa, on, K1S 0G8
Altana Pharma/Nycomed
Saskatoon,SK, S7H 0W2
Altana Pharma/Nycomed
Ste-Foy PQ, G1V 4M6
Altana Pharma/Nycomed
Toronto, M4V 1R2
Altana Pharma/Nycomed
Toronto, on, M3H 5S4
Altana Pharma/Nycomed
Winnipeg, R2M 5L9
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 Years of Age
The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.
- Conditions
- Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
- Being tested
- Ciclesonide
- Keywords
- Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclesonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Total Nasal Symptom Score
Secondary outcomes (1)
safety, changes in symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 636 participants
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
- NCT00163514
- Sponsor's protocol ID
- BY9010/M1-403
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2005
- 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, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 Years of Age
- ClinicalTrials.gov ID
- NCT00163514
- Acronym / sponsor ID
- BY9010/M1-403
- Conditions
- Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
- Keywords
- Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 14 Sep 2005 (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 purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 | Drug | – |
Primary outcome
changes in Total Nasal Symptom Score
1 secondary outcome
safety, changes in symptoms
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-M1-403-RDS-2005-12-09.pdfLink provided by the sponsor.
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Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
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
74 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciclesonide in people with Perennial Allergic Rhinitis and Allergic Rhinitis, run by AstraZeneca at 74 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 74 sites in United States, Canada. 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 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?
changes in Total Nasal Symptom Score. 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.