Blinded, randomly distributed 4-group study for finding the most efficient dose of Depigoid® Phleum in patients with hay fever with/without asthma.
- Conditions
- Allergic Rhinitis and/or Rhinoconjunctivitis with or without Intermittent AsthmaMedDRA version: 14.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 14.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2012-000416-28-ES
- Lead Sponsor
- ETI Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
Patients must meet ALL the following inclusion criteria to be considered for admission to the study:
1. Has provided appropriately signed and dated informed consent.
2. Is a male or female aged ? 18 years and ? 70 years of age at Visit 1.
3. Has a perception of disease activity of at least 30 mm on a 100 mm VAS.
4. Has an FEV1 or a PEFR value > 80% of predicted normal value.
5. Has complained about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years, with or without intermittent asthma symptoms, caused by clinical sensitisation against grass pollen. The IgE-mediated sensitisation must be verified by the following: suggestive medical history AND specific IgE against grass pollen using an ImmunoCAP specific IgE radioallergosorbent test (CAP-RAST) ? 2 AND a positive SPT AND a positive CPT for grass pollen.
An SPT will be considered positive if the test results in a wheal diameter that is at least 3 mm or - if smaller - equal to the histamine reaction.
A CPT will be considered positive if a score of 5 is achieved after treatment with any one of the following concentrations: 100, 330, 1,000, 3,300 or 10,000 SQ-U/mL.
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 (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Ambrosia elatior [ragweed]),
? with specific IgE CAP-RAST co-allergen < grass, as specified below:
- Birch (or other trees): specific IgE CAP-RAST of < 2 with a difference to grass of ? 2 and a negative SPT test OR a negative CPT,
- House dust mites: specific IgE CAP RAST of < 2 with a difference to grass of ? 2 and a negative SPT,
- Cats and dogs:
- exposed to animal: specific IgE CAP-RAST animal < grass with a difference to grass of ? 2 and an SPT wheal diameter co-allergen < grass
- not exposed to animal: CAP-RAST animal < grass.
- other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Ambrosia elatior [ragweed]): specific IgE CAP-RAST of < 2 with a difference to grass of ? 2 and a negative SPT test OR a negative CPT.
All other co-allergens: difference in specific IgE CAP RAST co-allergen to grass of ? 2 and an SPT wheal diameter co-allergen < grass.
6. If a female is of non-childbearing potential, the patient must be postmenopausal for at least 1 year or surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
7. If a female is of childbearing potential, the patient must be non-lactating and non-pregnant (with a negative pregnancy test result at Visit 1) and must correctly use an effective method of contraception
during the study. An effective method of contraception is defined as one that results in a failure rate of less than 1% per year. The following are allowed methods of contraception when used continuously and properly: hormonal contraceptives administered by implant, injection, or orally; complete abstinence; partner?s vasectomy if the female has
not more than one partner. Barrier methods (e.g., preservatives) are only considered effective if used together with one of the above.
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
Patients presenting any one of the following exclusion criteria must not be included in the study:
1. Acute, chronic or infectious conjunctivitis.
2. Has a history of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial allergens (e.g., house dust mites).
Patients are not allowed to enter into the study:
? with typical symptoms against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Ambrosia elatior [ragweed]),
? with CAP-RAST co-allergen ? grass.
3. Has persistent asthma, according to Global Initiative for Asthma (GINA) Guidelines32.
4. Has acute or chronic inflammatory or infectious airways disease.
5. Has chronic structural disease of the lung (e.g., emphysema or bronchiectasis).
6. Has an autoimmune and/or immune deficiency.
7. Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
8. Has a severe uncontrolled disease that could increase the risk to the patients while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.
9. Has had active malignant disease during the previous 5 years.
10. Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient.
11. Has abused alcohol, drugs or medications within the past year.
12. Has a severe psychiatric, psychological or neurological disorder.
13. Has used immunotherapy against grass pollen within the last 5 years.
14. Has used systemic and/or topical treatment with ?-blockers within 1 week prior to Visit 2.
15. Is using any medication that may interfere with the immune system or has been using any medication which might still have an influence on the immune system at Visit 2.
16. Has used tranquiliser or psychoactive drugs within 1 week prior to Visit 1.
17. Has used systemic corticosteroids within 3 months prior to Visit 1.
18. Has been immunised with vaccines within 7 days prior to Visit 2.
19. Is expected to be non-compliant and/or not cooperative.
20. Has participated in another clinical study within 30 days prior to Visit 2.
21. Has already participated in this study.
22. Is an employee at the investigational centre or first degree relative or partner of the investigator.
23. Plans to donate germ cells, blood, organs or bone marrow during the course of the study.
24. Is not contractually capable.
25. Has a positive pregnancy test at
Visit 1.
26. Is jurisdictionally or governmentally institutionalised.
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