Perennial Allergic RhinitisPhase 3NCT00163501
Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)
A Phase 3 study testing Ciclesonide in people with Perennial Allergic Rhinitis and Allergic Rhinitis, run by AstraZeneca at 41 sites in United States.
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 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
- What is being tested?
- Ciclesonide
- How many people
- 600 participants
- Where
- 41 sitesUnited States
- Study dates
- Dec 2003to Apr 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
- General good health, other than perennial allergic rhinitis
- History and diagnosis of perennial allergic rhinitis by skin prick test
Main Exclusion Criteria:
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
- Use of any prohibited concomitant medications as defined by the study protocol
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Altana Pharma/Nycomed
Atlanta, Georgia, 30342
Altana Pharma/Nycomed
Austin, Texas, 78731
Altana Pharma/Nycomed
Bethesda, Maryland, 20814
Altana Pharma/Nycomed
Cincinnati, Ohio, 45219
Altana Pharma/Nycomed
Cincinnati, Ohio, 45246
Altana Pharma/Nycomed
Clearwater, Florida, 33761
Altana Pharma/Nycomed
Cranston, Rhode Island, 02920
Altana Pharma/Nycomed
Dallas, Texas, 75231
Altana Pharma/Nycomed
DeLand, Florida, 32720
Altana Pharma/Nycomed
Easton, Pennsylvania, 18045
Altana Pharma/Nycomed
Encinitas, California, 92024
Altana Pharma/Nycomed
Forked River, New Jersey, 08731
Altana Pharma/Nycomed
Houston, Texas, 77054
Altana Pharma/Nycomed
Huntington Beach, California, 92647
Altana Pharma/Nycomed
Kerrville, Texas, 78028
Altana Pharma/Nycomed
Liverpool, New York, 13088
Altana Pharma/Nycomed
Long Beach, California, 90806
Altana Pharma/Nycomed
Los Angeles, California, 90025
Altana Pharma/Nycomed
Milwaukee, Wisconsin, 53201
Altana Pharma/Nycomed
Mission Viejo, California, 92691
Altana Pharma/Nycomed
New Braunfels, Texas, 78130
Altana Pharma/Nycomed
New Orleans, Louisiana, 70112
Altana Pharma/Nycomed
Newport Beach, California, 92660
Altana Pharma/Nycomed
Normal, Illinois, 61761
Altana Pharma/Nycomed
North Dartmouth, Massachusetts, 02747
Altana Pharma/Nycomed
Oklahoma City, Oklahoma, 73104
Altana Pharma/Nycomed
Overland Park, Kansas, 66210
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, 15241
Altana Pharma/Nycomed
Portland, Oregon, 97213
Altana Pharma/Nycomed
Raleigh, North Carolina, 27607
Altana Pharma/Nycomed
Richmond, Virginia, 23226
Altana Pharma/Nycomed
Salt Lake City, Utah, 84111
Altana Pharma/Nycomed
San Antonio, Texas, 78229
Altana Pharma/Nycomed
San Diego, California, 92103
Altana Pharma/Nycomed
San Diego, California, 92120
Altana Pharma/Nycomed
Skillman, New Jersey, 08558
Altana Pharma/Nycomed
Springfield, New Jersey, 07081
Altana Pharma/Nycomed
Stockton, California, 95207
Altana Pharma/Nycomed
Trumbull, Connecticut, 06611
Altana Pharma/Nycomed
Vista, California, 92083
Altana Pharma/Nycomed
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
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.
change in Total Nasal Symptom Scores.
Secondary outcomes (1)
change in symptoms, quality of life, safety.
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 startDec 2003
- Primary completionApr 2005
- Study completionApr 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 600 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
- NCT00163501
- Sponsor's protocol ID
- BY9010/M1-404
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2005
- 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, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
- ClinicalTrials.gov ID
- NCT00163501
- Acronym / sponsor ID
- BY9010/M1-404
- 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
- 600 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
change in Total Nasal Symptom Scores.
1 secondary outcome
change in symptoms, quality of life, 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-M1-404-RDS-2005-12-11.pdfLink provided by the sponsor.
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
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
41 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 in people with Perennial Allergic Rhinitis and Allergic Rhinitis, run by AstraZeneca at 41 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 41 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?
change in Total Nasal Symptom Scores.. 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.