Rhinitis, Allergic, SeasonalPhase 3NCT00659503
Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-407)
A Phase 3 study testing Ciclesonide in people with Rhinitis, Allergic, Seasonal and Hay Fever, run by AstraZeneca at 1 site in Canada.
Trial summary
The primary objective of this placebo-controlled EEU study is to determine the time to onset of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Hay Fever
- What is being tested?
- Ciclesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2005to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent signed and dated by the subject before conducting any study related procedure.
- Male or female patients 18 years and older.
- General good health, and free of any concomitant conditions or treatment that, in the judgment of the investigator, could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial.
- A history of SAR to short ragweed pollen for a minimum of two years immediately preceding the study entry (i.e., 2003 and 2004 pollen seasons). In the investigator's judgment, the SAR during this two- year period must have been of sufficient severity and would be expected to require treatment during the ragweed season.
- A demonstrated sensitivity to short ragweed pollen known to induce SAR through a standard skin prick test. A positive test is defined as a wheal diameter of at least 3 mm larger than the diluent (negative) control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (B0) is acceptable.
- Female is of child-bearing potential and is currently using and will continue to use a medically reliable method of contraception for the entire study duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection). Females who are not sexually active must agree to use double-barrier protection should they become sexually active during the course of the study. Women of child-bearing potential, or less than 1 year postmenopausal, will require a negative urine pregnancy test at the Screening Visit (B0) as well as prior to initiation of treatment at Treatment Visit (T0).Female subjects will be considered of non-childbearing potential and will not require a urine pregnancy test if at least one of the following apply:
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- Before menarche;
- More than one year postmenopausal;
- Had a hysterectomy;
- Had a bilateral ovariectomy or salpingectomy or tubal ligation;
- Have a congenital sterility.
- Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, is capable of giving informed consent, will comply with all study requirements (visits, record keeping, etc), is suitable to participate, and will provide conscientious cooperation over the duration of the study and possesses the characteristics suitable to undertake this study.
- Willingness to undergo a minimum of one (1) up to a maximum of five (5) priming sessions with short ragweed pollen in the EEU.
Who cannot join
- Pregnancy, nursing, or donation of gametes (ova or sperm) for in vitro fertilization during the study period or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization for 30 days following the study period. Females unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.
- Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based upon the clinical estimate by the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or nasal surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days prior to Screening Visit - B0).
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) and thereafter.
- Known hypersensitivity to any corticosteroid or any of the excipients in the formulation.
- History of severe respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (B0) and thereafter.
- History of alcohol or drug abuse within the preceding two years from Screening Visit (B0).
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- 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 or any controller drugs (e.g. theophylline, leukotriene antagonist); intermittent use (less than or equal to 3 uses per week) of inhaled short-acting b-agonists is acceptable.
- Use of any prohibited concomitant medications within the prescribed (per protocol) exclusion periods (refer to Section 6.3 of the protocol).
- Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0) and thereafter. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit (B0) AND is expected to continue through out the Baseline Period (B0 to T0 Visit) and Treatment Visit (T0).
- 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 (B0) AND use of a stable (maintenance) dose (28 days or more prior to the Screening Visit (B0)) may be considered for inclusion provided no immunotherapy injections are received within 48 hours prior to a ragweed pollen exposure visit.
- Previous participation in an intranasal ciclesonide study.
- Non-vaccinated exposure to or active 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., arthritis), during the past 60 days from Screening Visit (B0), 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 within 30 days prior to the Screening Visit (B0), or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study (B0 to T0 Visit, both visits inclusive). Hydrocortisone of less than or equal to 1% concentration covering less than or equal to 10% of the total body surface without occlusion is acceptable.
- History of epilepsy or seizures (excluding febrile seizures).
- History of coronary artery disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.
- History of malignancy (excluding basal cell carcinoma).
- Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial:
- Impaired hepatic function including alcohol related liver disease or cirrhosis;
- History of ocular disturbances e.g. glaucoma or posterior subcapsular cataracts;
- Any systemic infection;
- Hematological, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism);
- Gastrointestinal disease;
- A current neuropsychiatric condition with or without drug therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 18 Years and Older
The primary objective of this placebo-controlled EEU study is to determine the time to onset of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.
- Conditions
- Rhinitis, Allergic, Seasonal, Hay Fever
- Being tested
- Ciclesonide, Placebo
- Keywords
- Seasonal Allergic Rhinitis, Ciclesonide, Hay Fever, SAR
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclesonideDrug
200µg Ciclesonide versus Placebo
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ciclesonide 200µg Receives: Drug: Ciclesonide |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of action, measured by a difference from placebo in the change from baseline in patient- assessed instantaneous TNSS following treatment
Measured: 14 hours
Secondary outcomes (6)
Changes in TNSS from baseline at each time point
Measured: 14 hours
Changes in individual nasal symptom score from baseline at each time point
Measured: 14 hours
Proportion of patients exhibiting good/excellent response at each time point defined as all components of the patient-assessed TNSS scored as mild or less in severity.
Measured: 14 hours
Spontaneous and elicited adverse events (AEs)
Measured: 14 hours
Physical exam (including nasal exam)
Measured: 14 hours
Vital signs
Measured: 14 hours
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 startFeb 2005
- 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, SeasonalStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 420 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
- NCT00659503
- Sponsor's protocol ID
- BY9010/M1-407
- 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 Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 18 Years and Older
- ClinicalTrials.gov ID
- NCT00659503
- Acronym / sponsor ID
- BY9010/M1-407
- Conditions
- Rhinitis, Allergic, Seasonal, Hay Fever
- Keywords
- Seasonal Allergic Rhinitis, Ciclesonide, Hay Fever, SAR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- 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 placebo-controlled EEU study is to determine the time to onset of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CiclesonideCiclesonide 200µg |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent signed and dated by the subject before conducting any study related procedure.
- Male or female patients 18 years and older.
- General good health, and free of any concomitant conditions or treatment that, in the judgment of the investigator, could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial.
- A history of SAR to short ragweed pollen for a minimum of two years immediately preceding the study entry (i.e., 2003 and 2004 pollen seasons). In the investigator's judgment, the SAR during this two- year period must have been of sufficient severity and would be expected to require treatment during the ragweed season.
- A demonstrated sensitivity to short ragweed pollen known to induce SAR through a standard skin prick test. A positive test is defined as a wheal diameter of at least 3 mm larger than the diluent (negative) control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (B0) is acceptable.
Key exclusion criteria (25 listed)
- Pregnancy, nursing, or donation of gametes (ova or sperm) for in vitro fertilization during the study period or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization for 30 days following the study period. Females unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.
- Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based upon the clinical estimate by the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or nasal surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days prior to Screening Visit - B0).
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) and thereafter.
- Known hypersensitivity to any corticosteroid or any of the excipients in the formulation.
- History of severe respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (B0) and thereafter.
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 |
|---|---|---|
| Ciclesonide200µg Ciclesonide versus Placebo | Drug | 1 |
| Placeboplacebo | Drug | 2 |
Primary outcome
Time to onset of action, measured by a difference from placebo in the change from baseline in patient- assessed instantaneous TNSS following treatment
Time frame: 14 hours
6 secondary outcomes
Changes in TNSS from baseline at each time point
Time frame: 14 hours
Changes in individual nasal symptom score from baseline at each time point
Time frame: 14 hours
Proportion of patients exhibiting good/excellent response at each time point defined as all components of the patient-assessed TNSS scored as mild or less in severity.
Time frame: 14 hours
Spontaneous and elicited adverse events (AEs)
Time frame: 14 hours
Physical exam (including nasal exam)
Time frame: 14 hours
Vital signs
Time frame: 14 hours
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-M1-407-RDS-2005-11-11.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 in people with Rhinitis, Allergic, Seasonal and Hay Fever, run by AstraZeneca at 1 site in Canada.
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 13 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 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 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. 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?
Time to onset of action, measured by a difference from placebo in the change from baseline in patient- assessed instantaneous TNSS following treatment (time frame: 14 hours). 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; AzTrials last refreshed its copy on 28 Oct 2026.