Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctiviti… (NCT01634958) | Clinical Trial Compass
CompletedPhase 2
Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Germany308 participantsStarted 2012-10
Plain-language summary
Specific immunotherapy for IgE mediated sensitization to grass pollen
4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the optimum dose.
Who can participate
Age range
18 Years – 70 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:
* appropriately signed and dated ICON prior to study specific action
* IgE-mediated Sensitization against grass pollen
* Perception of disease activity of at least 30 mm on a 100 mm VAS
* FEV1 or a PEFR value \> 80% of predicted normal value
* Allergic rhinitis and/or rhinoconjunctivitis symptoms (at least 2 years) with or without intermittent asthma symptoms verified by:
* suggestive medical history AND
* specific IgE against grass pollen with CAP-RAST ≥ 2 AND
* a positive SPT (wheal diameter ≥ 3 mm) AND
* a positive CPT for grass pollen
* Patients with co-allergies are allowed to enter the study:
* being asymptomatic against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens
* with CAP-RAST co-allergen \< grass (detailed specifications given for Birch, HDM, animal dander, other country specific allergens)
* All other co-allergens: difference in CAP RAST co-allergen to grass of ≥ 2 and an SPT wheal diameter co-allergen \< grass
* Females of non-childbearing potential must be postmenopausal for at least
1 year or surgically sterilized
* Females of childbearing potential must be non-lactating, non-pregnant and must correctly use an effective method of contraception during the study.
Exclusion Criteria:
* Acute or chronic infectious conjunctivitis
* History of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial a…
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
1
Conjunctival Provocation Test (CPT)
Timeframe: At screening and after approx. 22 weeks (EoS)