Rhino-conjunctivitisPhase 2OsirisNCT01425788
Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense
A Phase 2 study testing Osiris Phleum pratense in people with Rhino-conjunctivitis, run by ALK-Abelló A/S at 1 site in Poland.
Trial summary
The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhino-conjunctivitis
- What is being tested?
- Osiris Phleum pratense
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2011to Feb 2012
- 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
- Written informed consent obtained before entering the trial
- Male or female >/= 18 years at visit 1
- A clinically relevant history of grass pollen induced allergic rhinoconjunctivitis (moderate to severe) and having received symptomatic treatment during grass pollen season 2010 and 2011
- Positive skin prick test response (wheal diameter >/= 3mm) to Phleum pratense
- Positive specific IgE against Phleum pratense (>/= 0,70KUL / class 2)
- Female subjects of childbearing potential must have a negative pregnancy test and be willing to practice appropriate contraceptive methods until Visit 4
- Subjects willing and able to comply with trial protocol regimen
Who cannot join
- Subjects included in another protocol (treatment intervention and/or investigational medicine product) or having participated in another clinical trial within 30 days prior to visit 1
- A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis caused by an allergen (e.g. hazel, alder, birch, ash) to which the subject will be exposed during the 30-day treatment period.
- A clinically relevant medical history of symptomatic perennial allergy to allergen(s) to which the subject is regularly exposed (e.g. cat, house dust mites).
- Known sensitization (history of positive SPT) to food allergens with oral allergy syndrome
- Uncontrolled asthma (in accordance with GINA guidelines) within the last 12 months
- FEV < 60% of predicted within the last 12 months
Show all 19Show fewer
- Severe asthma exacerbation(s) within the last 12 months
- A clinically relevant chronic disease (>/= 3 months) (e.g fibrosis, malignancy, type 1 diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency)
- Malignancy or systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease or immune deficiency disease)
- Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis or dental extraction at randomisation
- Medical history of recurrent urticaria or atopic dermatitis during the last 2 years
- Currently receiving treatment preventing the initiation of SIT (e.g. tricyclic antidepressants, mono amine oxidase inhibitors (MAOIs) and catechol-O-methyl transferase inhibitors (COMT inhibitors))
- History of allergy, hypersensitivity, or intolerance to the excipients of the investigational medicinal product
- Being immediate family of the investigator or trial staff, defined as the investigator's / staff's spouse, parent, grandparent, child or grandchild
- History of drug induced (incl. immunotherapy) facial angioedema (including experience of Quincke oedema) or a family (parents or siblings) history of hereditary angioedema
- Anticipated use of any prohibited medication within the specified time windows as defined in the protocol
- Previous treatment by immunotherapy with grass pollen for more than one month within the last 5 years
- Any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the trial evaluations or optimal participation
- History of anaphylaxis with cardio respiratory symptoms (e.g. food allergy, drugs or an idiopathic reaction)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poradnia Alergologii i Chorob Pluc Uniwersyteckiego Szpitala Klinicznego Nr1 im. N. Barlickiego w Lodzi
Lodz, 90-153
About this study
The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current practice.
- Conditions
- Rhino-conjunctivitis
- Being tested
- Osiris Phleum pratense
- Keywords
- Grass pollen induced allergic rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osiris Phleum pratenseBiological
Osiris Phleum pratenseBiological
Osiris Phleum pratenseBiological
| Study group | Role | What they receive |
|---|---|---|
| Osiris Phleum pratense - Group A | Active comparator | Group A up-dosing schedule from 1IR (index of Reactivity) /day to 240 IR/day in 11 days and thereafter 300 IR/day in 19 days.
Day 1-6: 1,2,4,6,8,10 IR/day Day 7-11: 30, 60, 120, 180, 240 IR/day Day 12-30: 300 IR/day Receives: Biological: Osiris Phleum pratense |
| Osiris Phleum pratense - Group B | Active comparator | Group B Up-dosing schedule:
Day 1-5: 50 IR/day Day 6-10: 150 IR/day Day 11-30: 300 IR/day Receives: Biological: Osiris Phleum pratense |
| Osiris Phleum pratense - Group C | Active comparator | Group C up-dosing schedule:
Day 1-10: 50 IR/day Day 11-20: 150 IR/day Day 21-30: 300 IR/day Receives: Biological: Osiris Phleum pratense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability based on reporting of adverse events
Recording of adverse events are performed during the entire trial period, from screening to final follow-up contact.
Measured: An average of 42 days per subject
Secondary outcomes (1)
Subject satisfaction
To compare the subjects' satisfaction of the different dosing schedules at end of the trial (after 30 days of treatment with trial medication).
Measured: Measured at "End of treatment/end of trial Visit"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhino-conjunctivitisStudies 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ergomed, ACM Pivotal Global Central Laboratory, Brecon Pharmaceuticals Ltd
- Responsible party
- Sponsor
- Investigators
- Piotr Kuna, Prof.med, Principal investigator, Uniwersytecki Szpital Kliniczny Nr1, Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425788
- Sponsor's protocol ID
- OS-G-01
- Acronym
- Osiris
- Status last verified
- Jun 2015
- First submitted
- 26 Aug 2011
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense
- ClinicalTrials.gov ID
- NCT01425788
- Acronym / sponsor ID
- Osiris / OS-G-01
- Conditions
- Rhino-conjunctivitis
- Keywords
- Grass pollen induced allergic rhinoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Ergomed, ACM Pivotal Global Central Laboratory, Brecon Pharmaceuticals Ltd
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Aug 2011 (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 trial is to investigate the tolerability of Osiris Phleum pratense used with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current practice.
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 Phleum pratense - Group A | Active comparator | Biological: Osiris Phleum pratenseGroup A up-dosing schedule from 1IR (index of Reactivity) /day to 240 IR/day in 11 days and thereafter 300 IR/day in 19 days. Day 1-6: 1,2,4,6,8,10 IR/day Day 7-11: 30, 60, 120, 180, 240 IR/day Day 12-30: 300 IR/day |
| Osiris Phleum pratense - Group B | Active comparator | Biological: Osiris Phleum pratenseGroup B Up-dosing schedule: Day 1-5: 50 IR/day Day 6-10: 150 IR/day Day 11-30: 300 IR/day |
| Osiris Phleum pratense - Group C | Active comparator | Biological: Osiris Phleum pratenseGroup C up-dosing schedule: Day 1-10: 50 IR/day Day 11-20: 150 IR/day Day 21-30: 300 IR/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent obtained before entering the trial
- Male or female >/= 18 years at visit 1
- A clinically relevant history of grass pollen induced allergic rhinoconjunctivitis (moderate to severe) and having received symptomatic treatment during grass pollen season 2010 and 2011
- Positive skin prick test response (wheal diameter >/= 3mm) to Phleum pratense
- Positive specific IgE against Phleum pratense (>/= 0,70KUL / class 2)
Key exclusion criteria (19 listed)
- Subjects included in another protocol (treatment intervention and/or investigational medicine product) or having participated in another clinical trial within 30 days prior to visit 1
- A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis caused by an allergen (e.g. hazel, alder, birch, ash) to which the subject will be exposed during the 30-day treatment period.
- A clinically relevant medical history of symptomatic perennial allergy to allergen(s) to which the subject is regularly exposed (e.g. cat, house dust mites).
- Known sensitization (history of positive SPT) to food allergens with oral allergy syndrome
- Uncontrolled asthma (in accordance with GINA guidelines) within the last 12 months
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 |
|---|---|---|
| Osiris Phleum pratense | Biological | Osiris Phleum pratense - Group A |
| Osiris Phleum pratense | Biological | Osiris Phleum pratense - Group B |
| Osiris Phleum pratense | Biological | Osiris Phleum pratense - Group C |
Primary outcome
Tolerability based on reporting of adverse events
Time frame: An average of 42 days per subject
Recording of adverse events are performed during the entire trial period, from screening to final follow-up contact.
1 secondary outcome
Subject satisfaction
Time frame: Measured at "End of treatment/end of trial Visit"
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 26 Jun 2015.
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.
Piotr Kuna, Prof.med principal investigator
Uniwersytecki Szpital Kliniczny Nr1, Lodz, Poland
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 Phleum pratense in people with Rhino-conjunctivitis, 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 7 inclusion and 19 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 26 Jun 2015. 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 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?
Tolerability based on reporting of adverse events (time frame: An average of 42 days per subject). 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 26 Jun 2015.