A randomised, double-blind, placebo-controlled, multi-centre, multi-national Phase II / III study to assess the efficacy and safety of three different dose regimens of Oralgen® Grass Pollen in patients with grass pollen-related allergic rhinoconjunctivitis
- Conditions
- Grass pollen-related rhinoconjunctivitisMedDRA version: 8.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitis
- Registration Number
- EUCTR2006-001548-30-SK
- Lead Sponsor
- Artu Biologicals Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
The inclusion criteria are to be verified at the Screening Visit and reviewed at Visit 1. In order for the patient to be enrolled in this study, he / she has to meet the following criteria:
1.Male or female out-patients aged 18 to 50 years (inclusive).
2.Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
3.Sensitised to the centre-specific grass pollen families as demonstrated by a positive skin prick test (wheal diameter more than 3 mm larger than the diluent control) and IgE value of at least Class II.
4.A RRTSS of greater than or equal to 14 during the pollen season prior to the start of the study.
5.Patients must be in general good health as determined by past medical history, physical examination, 12-lead ECG and safety laboratory tests.
6.Patients with a normal spirometry. Forced expiratory volume in 1 second (FEV1) at least 80% of the predicted value at Screening.
7.Patients who have been informed of the nature and aims of the study and have given their written consent / assent to participate in this study in accordance with local laws and requirements.
8.Patients who are willing to comply with the protocol and understand the information given and the text of the consent form.
9.Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method (for example, hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with male condom, bilateral tubal ligation, diaphragm used with spermicide, female condom, monogamous relationship with vasectomised partner).
Note: Female patients are considered not to have childbearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy, bilateral oophorectomy or ovariectomy.
10.Negative urine pregnancy test if female.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
2.Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included.
3.Patients who have taken oral steroids within 12 weeks before the Screening Visit.
4.Patients who have received desensitisation treatment for grass pollen.
5.Treatment by immunotherapy with any other allergen within the previous 5 years.
6.Patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the Screening Visit.
7.Patients at risk of non-compliance.
8.Participation in any other clinical study within the previous 3 months.
9.Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
10.Patients treated with beta-blockers or under continuous corticotherapy.
11.Allergic sensitivity to epithelial allergens (cats or any other animals) the patient is exposed to in his / her regular environment.
12.Positive skin prick test for environmental allergens such as house dust mites and cockroaches, and suffering from serious allergic symptoms due to exposure to these allergens during the study period.
13.The intention to subject the patient to surgery of the nasal cavity during the current study.
14.The usual contraindications of immunotherapy such as the following:
•Malignancies and serious disorders of the oral cavity.
•History of status asthmaticus and anaphylactic shock.
•Aggressively developing asthmatic symptoms.
•Serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes.
•Irreversible, secondary changes in reactive organs (emphysema, bronchiectasis).
•Auto-immune diseases and immunodeficiency.
•Concurrent therapy involving immunosuppressives.
•Systemic and collagen diseases.
•Tuberculosis.
•Serious psychological disorders.
•Documented hypersensitivity to glycerol.
•Use of beta-blockers.
15.A clinical history of symptomatic seasonal allergic rhinitis and / or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping, the grass pollen season.
16.A clinical history of significant symptomatic perennial allergic rhinitis and / or asthma caused by an allergen to which the patient is regularly exposed.
17.Patients at risk of being infected with hepatitis B, hepatitis C or human immunodeficiency virus.
18.Patients who received blood in the previous 3 months.
19.Patients with a history of drug or alcohol abuse.
20.Family members of investigators, co-investigators, and all the study collaborators should not be enrolled in the study.
Note: Skin prick test for grass pollen and other allergens: a washout period of 3 days is required for any antihistamines. However, for desloratadine or loratadine, the washout period must be a minimum of 10 days.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method