Hay FeverPhase 3NCT00305487
Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
A Phase 3 study testing Ciclesonide nasal spray in people with Hay Fever and Seasonal Allergic Rhinitis, run by AstraZeneca at 71 sites in United States.
Trial summary
The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks). Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Hay Fever, Seasonal Allergic Rhinitis
- What is being tested?
- Ciclesonide nasal spray
- How many people
- 660 participants
- Where
- 71 sitesUnited States
- Study dates
- Mar 2006to Oct 2006
- 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:
- Written informed consent
- General good health other than seasonal allergic rhinitis
- Positive standard skin prick test
Main Exclusion Criteria:
- Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit
- A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
- Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
- Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
- Use of any prohibited concomitant medications
- Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
- Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
- Study participation by more than one patient from the same household
Trial locations and contacts
71 sites in 1 country.
71 sites in 1 country
United States71 sites
Altana Pharma/Nycomed
Ashland, Oregon, 97520
Altana Pharma/Nycomed
Atlanta, Georgia, 30342
Altana Pharma/Nycomed
Austin, Texas, 78731
Altana Pharma/Nycomed
Austin, Texas, 78750
Altana Pharma/Nycomed
Bethesda, Maryland, 20814
Altana Pharma/Nycomed
Birmingham, Alabama, 35235
Altana Pharma/Nycomed
Blue Bell, Pennsylvania, 19422
Altana Pharma/Nycomed
Brick, New Jersey, 08724
Altana Pharma/Nycomed
Burke, Virginia, 22015
Altana Pharma/Nycomed
Charleston, South Carolina, 29414
Altana Pharma/Nycomed
Charleston, SC, South Carolina, 29407
Altana Pharma/Nycomed
Charlottesville, Virginia, 22911
Altana Pharma/Nycomed
Cincinnati, Ohio, 45219
Altana Pharma/Nycomed
Cincinnati, OH, Ohio, 45231
Altana Pharma/Nycomed
Colorado Springs, Colorado, 80907
Altana Pharma/Nycomed
Costa Mesa, California, 92626
Altana Pharma/Nycomed
Dallas, Texas, 75231
Altana Pharma/Nycomed
Denver, Colorado, 80230
Altana Pharma/Nycomed
Eerie, Pennsylvania, 16506
Altana Pharma/Nycomed
El Paso, Texas, 79925
Altana Pharma/Nycomed
Englewood, Colorado, 80112
Altana Pharma/Nycomed
Forked River, New Jersey, 08731
Altana Pharma/Nycomed
Gainesville, Georgia, 30501
Altana Pharma/Nycomed
Germantown, Tennessee, 38138
Altana Pharma/Nycomed
Hot Springs, Arkansas, 71913
Altana Pharma/Nycomed
Huntington Beach, California, 92647
Altana Pharma/Nycomed
Indianapolis, Indiana, 46208
Altana Pharma/Nycomed
Jackson, Tennessee, 38301
Altana Pharma/Nycomed
Jefferson City, Missouri, 65109
Altana Pharma/Nycomed
Kerrville, Texas, 78028
Altana Pharma/Nycomed
Lake Oswego, Oregon, 97035
Altana Pharma/Nycomed
Lakewood, CO, Colorado, 80401
Altana Pharma/Nycomed
Lincoln, NE, Nebraska, 68505
Altana Pharma/Nycomed
Long Beach, California, 90806
Altana Pharma/Nycomed
Los Alamitos, California, 90720
Altana Pharma/Nycomed
Louisville, KY, Kentucky, 40215
Altana Pharma/Nycomed
Medford, OR, Oregon, 97504
Altana Pharma/Nycomed
Metairie, Louisiana, 70006
Altana Pharma/Nycomed
Milwaukee, Wisconsin, 53209
Altana Pharma/Nycomed
Minneapolis, Minnesota, 55402
Altana Pharma/Nycomed
Mission Viejo, California, 92691
Altana Pharma/Nycomed
New Braunfels, Texas, 78130
Altana Pharma/Nycomed
Normal, Illinois, 61761
Altana Pharma/Nycomed
North Dartmouth, Massachusetts, 02747
Altana Pharma/Nycomed
Orange, California, 92868
Altana Pharma/Nycomed
Overland Park, Kansas, 66211
Altana Pharma/Nycomed
Papillion, Nebraska, 68046
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, 15202
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, 15241
Altana Pharma/Nycomed
Portland, Oregon, 97213
Altana Pharma/Nycomed
Raleigh, North Carolina, 27607
Altana Pharma/Nycomed
Red Bank, New Jersey, 07701
Altana Pharma/Nycomed
Richmond, Virginia, 23226
Altana Pharma/Nycomed
Rochester, NY, New York, 14618
Altana Pharma/Nycomed
Rockville Centre, New York, 11570
Altana Pharma/Nycomed
Rolla, Missouri, 65401
Altana Pharma/Nycomed
Roseville, California, 95678
Altana Pharma/Nycomed
Salt Lake City, Utah, 84037
Altana Pharma/Nycomed
San Antonio, Texas, 78229
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, 71105
Altana Pharma/Nycomed
Skillman, New Jersey, 08558
Altana Pharma/Nycomed
South Burlington, Vermont, 05403
Altana Pharma/Nycomed
St Louis, Missouri, 63141
Altana Pharma/Nycomed
Stockton, California, 95207
Altana Pharma/Nycomed
Upland, Pennsylvania, 19013
Altana Pharma/Nycomed
Warren Township, New Jersey, 07059
Altana Pharma/Nycomed
Woodstock, GA, Georgia, 30188
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age
The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).
- Conditions
- Hay Fever, Seasonal Allergic Rhinitis
- Being tested
- Ciclesonide nasal spray
- Keywords
- Hay Fever, Seasonal Allergic Rhinitis, Nasal spray, Ciclesonide, Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide nasal sprayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
Secondary outcomes (3)
Physician assessment of nasal symptoms score at endpoint
average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hay FeverStudies 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
- Double blind
- Enrolment
- 660 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
- NCT00305487
- Sponsor's protocol ID
- BY9010/M1-417
- Status last verified
- Oct 2016
- First submitted
- 21 Mar 2006
- Last updated
- 30 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 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 and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age
- ClinicalTrials.gov ID
- NCT00305487
- Acronym / sponsor ID
- BY9010/M1-417
- Conditions
- Hay Fever, Seasonal Allergic Rhinitis
- Keywords
- Hay Fever, Seasonal Allergic Rhinitis, Nasal spray, Ciclesonide, Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 22 Mar 2006 (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 aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).
Study design
- Primary purpose
- Treatment
- 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 nasal spray | Drug | – |
Primary outcome
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
3 secondary outcomes
Physician assessment of nasal symptoms score at endpoint
average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
safety
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 30 Nov 2016.
- BY9010-M1-417-RDS-2007-04-27.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
71 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 spray in people with Hay Fever and Seasonal Allergic Rhinitis, run by AstraZeneca at 71 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?
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 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 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 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?
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment. 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 30 Nov 2016.