EUCTR2012-000416-28-CZActive, not recruitingNot Applicable
A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum in Patients with Allergic Rhinitis and/or Rhinoconjunctivitis with or without Intermittent Asthma
ETI Pharma GmbH0 sites320 target enrollmentStarted: May 15, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 320
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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 ß-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
- •26. Is jurisdictionally or governmentally institutionalised.
Investigators
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