Allergic RhinitisPhase 2NCT01240954
Comparison of Different Up-dosing Schedules With Osiris
A Phase 2 study testing OSIRIS, OSIRIS other concentration 1 and OSIRIS other concentration 2 in people with Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in Poland.
Trial summary
The purpose of this study is to compare different up-dosing schedules with Osiris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- OSIRIS, OSIRIS other concentration 1 and OSIRIS other concentration 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2010to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of grass pollen allergy
- Positive SPT to grass
- Positive IgE to grass
Who cannot join
- uncontrolled and severe asthma
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare different up-dosing schedules with Osiris.
- Conditions
- Allergic Rhinitis
- Being tested
- OSIRIS, OSIRIS other concentration 1, OSIRIS other concentration 2
- Keywords
- Rhinitis, Allergic, Immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSIRISDrug
OSIRIS current practice
OSIRIS other concentration 1Drug
OSIRIS new concentration 1
OSIRIS other concentration 2Drug
OSIRIS new concentration 2
| Study group | Role | What they receive |
|---|---|---|
| OSIRIS | Active comparator | Not described Receives: Drug: OSIRIS |
| OSIRIS other concentration 1 | Experimental | Not described Receives: Drug: OSIRIS other concentration 1 |
| OSIRIS other concentration 2 | Experimental | Not described Receives: Drug: OSIRIS other concentration 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the tolerability of different up-dosing schedules
Measured: 30 days
Secondary outcomes (1)
patient's satisfaction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startDec 2010
Why it stopped: CA approval not obtained
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240954
- Sponsor's protocol ID
- OS-I-01
- Status last verified
- Aug 2011
- First submitted
- 11 Nov 2010
- Last updated
- 29 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Up-dosing Schedules With Osiris
- ClinicalTrials.gov ID
- NCT01240954
- Acronym / sponsor ID
- OS-I-01
- Conditions
- Allergic Rhinitis
- Keywords
- Rhinitis, Allergic, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CA approval not obtained
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- First posted
- 15 Nov 2010 (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 compare different up-dosing schedules with Osiris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSIRIS | Active comparator | Drug: OSIRIS |
| OSIRIS other concentration 1 | Experimental | Drug: OSIRIS other concentration 1 |
| OSIRIS other concentration 2 | Experimental | Drug: OSIRIS other concentration 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- history of grass pollen allergy
- Positive SPT to grass
- Positive IgE to grass
Key exclusion criteria (1 listed)
- uncontrolled and severe asthma
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 |
|---|---|---|
| OSIRISOSIRIS current practice | Drug | OSIRIS |
| OSIRIS other concentration 1OSIRIS new concentration 1 | Drug | OSIRIS other concentration 1 |
| OSIRIS other concentration 2OSIRIS new concentration 2 | Drug | OSIRIS other concentration 2 |
Primary outcome
evaluate the tolerability of different up-dosing schedules
Time frame: 30 days
1 secondary outcome
patient's satisfaction
Time frame: 30 days
Results and safety
The study was stopped early (reason given: CA approval not obtained). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
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RecruitingPhase 3
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 OSIRIS, OSIRIS other concentration 1 and OSIRIS other concentration 2 in people with Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in Poland.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 Aug 2011. 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 Poland. 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 was stopped early (reason given: CA approval not obtained). Results are not available in the source record.
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?
evaluate the tolerability of different up-dosing schedules (time frame: 30 days). 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 29 Aug 2011.