A randomised, double-blind, placebo-controlled, multi national, Phase III study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT), starting 2 months before the grass pollen season, administered as allergen based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis (with or without asthma)
- Conditions
- Grass pollen allergic rhinoconjunctivitisMedDRA version: 9.1Level: LLTClassification code 10039085Term: Rhinitis allergicMedDRA version: 9.1Level: PTClassification code 10039085Term: Rhinitis allergic
- Registration Number
- EUCTR2008-003906-32-CZ
- Lead Sponsor
- Stallergenes S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
Patients must meet all of the following inclusion criteria in order to participate in this study:
1. Written consent.
2. Male or female outpatients aged 18 to 65 years (inclusive).
3. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
4. Positive SPT (wheal diameter greater than 3 mm) and grass pollen-specific IgE values of at least 0.70 kU/L.
5. An RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18. The RRTSS is an evaluation (by the patient) of the most severe symptoms during the previous pollen season.
6. Patients in general good health as determined by the medical history, physical examination (including vital signs) and safety laboratory tests.
7. Patients with FEV1 = 80% of the predicted value.
8. Female patients are eligible if they do not have child bearing potential. Female patients are considered not to have child-bearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy or bilateral oophorectomy.
9. Female patients of child-bearing potential are eligible if they are not sexually active or if they:
Use a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner), and
Have a negative urine pregnancy test.
10. Patients who are able to understand the information given, and will be compliant with the protocol including investigational product administration and visit schedules. Patients should also be able to complete the daily record card.
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
Patients must not meet any of the following exclusion criteria in order to participate in this study:
1. Positive SPT to any other seasonal allergens present during the grass pollen season including olive and cypress pollen if these allergens are endemic to the region.
2. Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season (for example, tree allergens).
3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
4. Patients with moderate or severe persistent asthma (GINA 3 or 4).
5. Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
6. Patients who have received any desensitisation treatment for grass pollen in the last 5 years.
7. Patients with ongoing treatment by immunotherapy with any other allergen.
8. Patients with any nasal or oral condition that could confound the efficacy or safety assessments such as nasal polyposis, chronic sinusitis or oral inflammation (for example oral lichen planus, oral ulceration or oral mycosis).
9. Patients with a known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as galactose intolerance).
10. Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study. These may include, but are not limited to, anaphylaxis with cardio-respiratory symptoms, chronic urticaria and angioedema, severe atopic dermatitis, malignancy, and cardiovascular, hepatic, renal, haematological, neurological, immunological and endocrine diseases.
11. Patients treated with systemic, nasal or inhaled corticosteroids within 4 weeks before Visit 1 or with long acting systemic corticosteroids within 12 weeks before Visit 1, whatever the indication.
12. Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs.
13. Pregnant, breastfeeding, or sexually active females who are not using a medically accepted contraceptive method as listed above.
14. Patients participating or having participated within 12 weeks before Visit 1 in any clinical study.
15. Patients who are likely to be unable to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which in the opinion of the investigator will compromise the data.
16. Patients with a history of drug or alcohol abuse.
17. Investigators, sub-investigators and study staff as well as their children or spouses and family members should not be enrolled in the study.
18. Patients must not be randomised in this study more than once.
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