Allergic RhinitisPhase 2NCT00697281
OC000459 Dose Finding Study in Hay Fever Sufferers.
A Phase 2 study testing OC000459 in people with Allergic Rhinitis, run by Oxagen Ltd at 1 site in Austria.
Trial summary
The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- OC000459
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- May 2008to Sep 2008
- Phase
- Phase 2
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
- Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening.
- Acceptable contraception includes the use of TWO of the following:
- oral contraception (i.e. the Pill);
- intrauterine device (an IUD or 'Coil');
- barrier contraception (i.e. condoms or diaphragm/cap);
- transdermal patch
Who cannot join
- Medical conditions likely to affect the outcome of the study.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee.
- Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
- Immunotherapy treatment course in the past 28 days
- Use of inhaled or local corticosteroids in the past 28 days.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Allergie Zentrum Wien West, Vienna Challenge Chamber
Vienna, 1150 VIENNA
About this study
Official title: A Dose Finding Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis.
The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis
Read the detailed description
This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.
- Conditions
- Allergic Rhinitis
- Being tested
- OC000459, Placebo
- Keywords
- allergic rhinitis, human, clinical trial, efficacy, safety, challenge test
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC000459Drug
Tablets twice daily for 8 days
Dose level 1
OC000459Drug
Tablets twice daily for 8 days
Dose level 2
OC000459Drug
Tablets twice daily for 8 days
Dose level 3
OC000459Drug
Tablets twice daily for 8 days
Dose level 4
PlaceboDrug
Tablets twice daily for 8 days
Dose level 5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose level 1 Receives: Drug: OC000459 |
| 2 | Experimental | Dose level 2 Receives: Drug: OC000459 |
| 3 | Experimental | Dose level 3 Receives: Drug: OC000459 |
| 4 | Experimental | Dose level 4 Receives: Drug: OC000459 |
| 5 | Experimental | Dose level 5 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptom score (TNSS)
Measured: After 8 days of treatment
Secondary outcomes (1)
Other symptom scores of allergic rhinitis
Measured: After 8 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxagen Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Univ Prof. Dr. Friedrich Horak, MD, Principal investigator, Allergie Zentrum Wien West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697281
- Sponsor's protocol ID
- OC000459/010/07
- Status last verified
- Feb 2009
- First submitted
- 11 Jun 2008
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT00697281
- Acronym / sponsor ID
- OC000459/010/07
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, human, clinical trial, efficacy, safety, challenge test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oxagen LtdIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Jun 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 evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis
Detailed description
This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OC000459Dose level 1 |
| 2 | Experimental | Drug: OC000459Dose level 2 |
| 3 | Experimental | Drug: OC000459Dose level 3 |
| 4 | Experimental | Drug: OC000459Dose level 4 |
| 5 | Experimental | Drug: PlaceboDose level 5 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
- Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening.
- Acceptable contraception includes the use of TWO of the following:
Key exclusion criteria (5 listed)
- Medical conditions likely to affect the outcome of the study.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee.
- Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
- Immunotherapy treatment course in the past 28 days
- Use of inhaled or local corticosteroids in the past 28 days.
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 |
|---|---|---|
| OC000459Tablets twice daily for 8 days Dose level 1 | Drug | 1 |
| OC000459Tablets twice daily for 8 days Dose level 2 | Drug | 2 |
| OC000459Tablets twice daily for 8 days Dose level 3 | Drug | 3 |
| OC000459Tablets twice daily for 8 days Dose level 4 | Drug | 4 |
| PlaceboTablets twice daily for 8 days Dose level 5 | Drug | 5 |
Primary outcome
Total nasal symptom score (TNSS)
Time frame: After 8 days of treatment
1 secondary outcome
Other symptom scores of allergic rhinitis
Time frame: After 8 days of treatment
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 24 Feb 2009.
Related trials for Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
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.
Univ Prof. Dr. Friedrich Horak, MD principal investigator
Allergie Zentrum Wien West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OC000459 in people with Allergic Rhinitis, run by Oxagen Ltd at 1 site in Austria.
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 7 inclusion and 5 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 24 Feb 2009. 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 Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total nasal symptom score (TNSS) (time frame: After 8 days 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 24 Feb 2009.