CompletedPhase 4

PURETHAL Birch RUSH Study

Poland120 participantsStarted 2013-09

Plain-language summary

This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks). The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes. A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent. * Age ≥12 years. * Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma * FEV1\>70% for patients with a history of mild to moderate asthma, FEV1\>70% or PEF\>80% for patients without a history of asthma * A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen. * Positive serum specific anti-birch IgE-test (\>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization. Exclusion Criteria: * Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years * Any specific immunotherapy (SCIT or SLIT) during the study period * Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs * Active malignancies or any malignant disease within the past 5 years * Severe uncontrolled diseases that could increase the risk for patients participating in the study * Acute/active inflammation or infection of the target organs at the start of the study * Secondary changes of the target organ * Diseases with a contraindication for the use of adrenaline * Use of systemic steroids within 4 weeks before start of the study and during the study * Treatment with systemic and local β-blockers * Vaccination within one week before start of therapy or during the initiation phase …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients successfully reaching the maintenance dose

Timeframe: 12 weeks

Trial details

NCT IDNCT01918956

SponsorHAL Allergy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

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