Actively Recruiting
Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
Led by Inmunotek S.L. · Updated on 2025-05-13
180
Participants Needed
27
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.
CONDITIONS
Official Title
Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Aged between 12 and 65 years, any gender
- Clinical history of intermittent or persistent moderate to severe rhinitis or rhinoconjunctivitis with or without moderate intermittent or persistent asthma caused by grass and cupressaceae pollen
- Positive skin prick test with wheal size greater than 5 mm to standardized grass or cupressaceae pollen extracts, with papule diameter equal or larger than histamine control
- Specific IgE levels above 3.5 KU/L against grass and cupressaceae pollen
- Negative pregnancy test for women of childbearing age at trial start
- Women of childbearing potential must agree to use accepted contraception methods
- Ability to comply with dosing regimen
- Ownership of a smartphone for symptom and medication recording
- Negative prick tests to co-seasonal pollens with specific IgE below 3.5 KU/L and no relevant symptoms
- Negative prick tests to other aeroallergens including dust mites, epitheliums, and fungus, with specific IgE below 3.5 KU/L and no relevant symptoms
You will not qualify if you...
- Positive prick test to aeroallergens other than pollen with exceptions for occasional epithelia exposure
- Prior allergen immunotherapy within 5 years or current immunotherapy
- Contraindications to immunotherapy as defined by allergy societies
- Severe or uncontrolled asthma with FEV1 below 70% despite treatment
- Severe rhinitis or rhinoconjunctivitis requiring ongoing oral or systemic antihistamines
- Severe reactions to diagnostic skin prick tests
- Treatment with beta-blockers
- Clinically unstable conditions such as acute asthma, infections, or urticaria
- Active chronic urticaria, severe skin conditions, or history of hereditary angioedema
- Conditions contraindicating adrenaline use like hyperthyroidism, hypertension, or heart disease
- Serious unrelated diseases that may affect treatment or follow-up
- Autoimmune diseases, tumors, or immunodeficiencies
- Severe psychiatric disorders or inability to cooperate
- Allergy to components of the investigational product other than allergens
- Lower respiratory diseases other than asthma
- Direct relatives of study researchers
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Hospital Recoletas Felipe Ii
Valladolid, Castille and León, Spain, 47003
Actively Recruiting
2
Cedt de Tarancón
Tarancón, Cuenca, Spain, 16400
Actively Recruiting
3
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain, 28806
Completed
4
Hospital U. Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Actively Recruiting
5
Hospital Cruz Roja Madrid
Madrid, Madrid, Spain, 28003
Actively Recruiting
6
Clínica Privada Dres Ojeda
Madrid, Madrid, Spain, 28006
Actively Recruiting
7
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Not Yet Recruiting
8
Clínica Privada Murcia
Murcia, Murcia, Spain, 30006
Not Yet Recruiting
9
Hospital Nuestra Señora de Sonsoles
Ávila, Spain, 05071
Not Yet Recruiting
10
Fundación Hospital Sant Pere Claver
Barcelona, Spain, 08004
Withdrawn
11
Clínica privada Burgos
Burgos, Spain, 09004
Withdrawn
12
Hospital Universitario de Burgos
Burgos, Spain, 09006
Actively Recruiting
13
Hospital General de Villalba
Collado Villalba, Spain, 28400
Not Yet Recruiting
14
Clinica privada
León, Spain, 24003
Withdrawn
15
Clínica Subiza
Madrid, Spain, 28006
Active, Not Recruiting
16
Hospital Carlos III (antiguo CAP José Marva)
Madrid, Spain, 28029
Withdrawn
17
Clínica Privada
Madrid, Spain, 28034
Withdrawn
18
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Not Yet Recruiting
19
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
20
Hospital Infanta Elena
Madrid, Spain, 28342
Not Yet Recruiting
21
Centro médico Saluddia
Madrid, Spain, 28522
Actively Recruiting
22
Centro Médico Iza (Clínica Privada Madrid)
Madrid, Spain, 28760
Actively Recruiting
23
Consulta Privada
Palencia, Spain, 34001
Completed
24
Hospital Clínico de Salamanca
Salamanca, Spain, 37007
Active, Not Recruiting
25
Hospital General Universitario de Segovia
Segovia, Spain, 40002
Not Yet Recruiting
26
Clinica Privada Soria
Soria, Spain, 42005
Withdrawn
27
Clínica Privada
Zaragoza, Spain, 50004
Withdrawn
Research Team
M
Miguel Casanovas, MD PhD
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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