Multicenter, Randomized, Double-Blind Placebo-Controlled Study, Subcutaneous Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum pratense Pollen in Hypersensitivity Patients to grass Pollen.
- Conditions
- Moderate-severe rhinitis or rhinoconjunctivitis (with or without asthma) due to hypersensitivity to grass pollen.MedDRA version: 14.1Level: LLTClassification code 10039097Term: RhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2006-005868-10-HU
- Lead Sponsor
- aboratorios LETI S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 148
•Informed consent, signed by the patient.
•Clinical history of moderate to severe rhinitis/rhinoconjunctivitis lasting for at least 2 consecutive years, with or without episodic asthma, caused by allergy to grass pollen. Moderate to severe rhinoconjunctivitis is defined as having one or more of the following symptoms: sleep disorders; difficulties in performing routine leisure and/or sports activities; difficulties in carrying out everyday work or school activities; symptoms that cause discomfort to the patient.
Patients who have both rhinitis/rhinoconjunctivitis and episodic asthmatic symptoms will be identified by a normal spirometry and the absence of symptoms outside the pollination season. The following criteria during the pollination period must be fulfilled, either through the patient’s clinical history or during the spring of the current year:
a) Worsening of the pulmonary function ?15% in FEV1 or 25% of FEF25-75% compared to controls performed during a previous period with no antigen load.
b) Obstructive spirometry with an improvement of >12% in FEV1 after use of short-acting bronchodilator, beta-agonist.
c) In the case of obstructive spirometry with no improvement following short-acting B2 agonist, anti-inflammatory medication will be added to control the symptoms. At the end of the pollination season, patient will have to show an increase in the FEV1 value of at least 12% with respect to the baseline value.
d) In the case of a normal spirometry and a history suggestive of exercise-induce asthma, confirmation of a change of ?10% with respect to the baseline values is necessary after the stress test*.
•Aged between 18 and 55 years.
•Symptoms that coincide with allergy to grass pollen, defined as the presence of seasonal symptoms (during the most intensive grass pollination period) such as sneezing, a runny, blocked or itchy nose, reddening of the eyes, irritation or itching of the eyes, tearing, which may or may not be accompanied by coughing, wheezing and dyspnoea.
•Sensitivity to grass pollen, diagnosed through a positive skin reaction to Phleum pratense: the papule produced by the prick-test must be equal to or larger than the papule produced by the positive control (histamine 10 mg/ml); and/or due to the presence of specific IgE versus P. pratense >0.7 kU/L. The patients included must be mono-sensitised or, in the case of poly-sensitisation, sensitivity to P. pratense pollen should be considered as the only relevant aspect of their condition from the clinical standpoint during the time they are included in the study. The result of immunoserology tests performed within less than one year will be accepted.
•Patients who are able to:
Comply with the dose regime
Give their informed consent
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 148
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Patients suffering from only mild rhinitis/rhinoconjunctivitis
•Patients outside the specified age group.
•Relevant sensitivity to any other perennial allergen (fungi, animal epithelia, etc. if not removed from the patient’s vicinity).
•Patients who have previously received immunotherapy for asthma or allergic rhinitis/rhinoconjunctivitis during the past 4 years. Neither may patients for whom immunotherapy is absolutely contraindicated in general in accordance with the criteria of the Immunotherapy Committee of the Spanish Allergy and Clinical Immunology Society (1) and the European Allergy and Clinical Immunology Immunotherapy Subcommittee (2) be included: Patients being treated with ß-blocker drugs.
•Patients suffering from pathologies in which adrenalin is contraindicated (hyperthyroidism, HBP, heart disease, etc.).
•Patients with other diseases not related to asthma but which are potentially serious and could interfere with treatment and follow-up (epilepsy, psychomotor alterations, diabetes, malformations, patients undergoing repeated surgery, kidney disease,..).
•Autoimmune diseases (thyroiditis, lupus, etc.).
•Patients who are unable to cooperate, and who suffer from severe psychiatric alterations.
•The co-existence of intolerance to aspirin.
•Patients who are pregnant or planning to become pregnant and patients who are breastfeeding.
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