Actively Recruiting
Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
Led by Inmunotek S.L. · Updated on 2025-05-07
180
Participants Needed
32
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive
CONDITIONS
Official Title
Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Aged between 12 and 65 years.
- Confirmed clinical history of mild to moderate rhinitis, rhinoconjunctivitis, with or without mild to moderate controlled asthma caused by grass and olive allergy.
- Positive skin prick test (papule diameter 65 mm) to grass pollen mixture or olive extract.
- Specific IgE level above 3.5 KU/L for grasses or olive pollen.
- Negative pregnancy test for women of childbearing age at enrollment.
- Commitment to use appropriate contraception for women of childbearing potential and men.
- Ability to comply with treatment dosage.
- Possession of a smartphone to record symptoms and medication.
- Negative skin prick test to co-seasonal and other aeroallergens with no relevant symptoms and specific IgE below 3.5 kU/L.
You will not qualify if you...
- Polysensitized to other aeroallergens except occasional exposure to epithelia or non-seasonal pollens.
- Received immunotherapy for aeroallergens in the last 5 years.
- Absolute contraindications for immunotherapy.
- Severe or uncontrolled persistent asthma with FEV1 below 70% despite treatment.
- Severe rhinitis/rhinoconjunctivitis requiring continuous oral or systemic antihistamines.
- Serious reactions to prior skin prick tests.
- Treatment with beta-blockers.
- Clinically unstable at enrollment (e.g., asthma exacerbation, infection, fever).
- Active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, active psoriasis on test areas, or hereditary angioedema.
- Conditions contraindicating adrenaline administration.
- Other severe diseases that may interfere with treatment or follow-up.
- Autoimmune diseases, tumors, immunodeficiencies.
- Severe psychiatric disorders preventing cooperation.
- Allergy to investigational drug components other than allergens.
- Lower respiratory diseases other than asthma.
- Direct relatives of researchers.
- Pregnant or lactating women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Cedt de Tarancón
Tarancón, Cuenca, Spain, 16400
Actively Recruiting
2
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
Completed
3
Centro Médico Iza
Tres Cantos, Madrid, Spain, 28760
Actively Recruiting
4
Hospital Infanta Elena
Valdemoro, Madrid, Spain, 28342
Actively Recruiting
5
Hospital Clínico Universitario Virgen de Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
6
Private Practice
Albacete, Spain, 02003
Withdrawn
7
Hospital Ntra. Sra. de Sonsoles
Ávila, Spain, 05004
Actively Recruiting
8
Clinica Dermatologica Y Alergia
Badajoz, Spain, 06001
Actively Recruiting
9
Hospital Quironsalud Clideba
Badajoz, Spain, 06011
Actively Recruiting
10
Hospital Universitario Dexeus
Barcelona, Spain, 08028
Actively Recruiting
11
Clínica privada Barcelona
Barcelona, Spain, 08172
Withdrawn
12
Hospital General Universitario Ciudad Real
Ciudad Real, Spain, 13005
Actively Recruiting
13
Hospital Quironsalud Córdoba
Córdoba, Spain, 14004
Actively Recruiting
14
Hospital Universitario Clínico San Cecilio
Granada, Spain, 18016
Active, Not Recruiting
15
Hospital Universitario de Jaén
Jaén, Spain, 23007
Actively Recruiting
16
Hospital Universitari Santa María
Lleida, Spain, 25198
Actively Recruiting
17
Private practice
Madrid, Spain, 28001
Withdrawn
18
Hospital Universitario Cruz Roja
Madrid, Spain, 28003
Actively Recruiting
19
Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
Madrid, Spain, 28006
Actively Recruiting
20
Clínica Subiza
Madrid, Spain, 28006
Actively Recruiting
21
Hospital Carlos Iii
Madrid, Spain, 28029
Completed
22
Hospital Universitario Rey Juan Carlos
Madrid, Spain, 28933
Withdrawn
23
Hospital Quirónsalud Málaga
Málaga, Spain, 29004
Actively Recruiting
24
Private Practice
Málaga, Spain
Actively Recruiting
25
Private Practice
Murcia, Spain
Actively Recruiting
26
Private Practice
Palencia, Spain, 34001
Completed
27
Hospital Universitario Infanta Cristina
Parla, Spain, 28981
Actively Recruiting
28
Clínica privada Sevilla
Seville, Spain, 41005
Withdrawn
29
Hospital Virgen Del Rocío
Seville, Spain, 41013
Actively Recruiting
30
Hospital Viamed Santa Ángela de La Cruz
Seville, Spain, 41014
Actively Recruiting
31
Private Practice
Toledo, Spain, 45005
Withdrawn
32
Hospital Recoletas Felipe Ii
Valladolid, Spain, 47003
Actively Recruiting
Research Team
M
Miguel Casanovas
CONTACT
R
Raquel Caballero
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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