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
Double blind, multicenter, parallel, placebo controlled study. It includes 180 subjects sensitised to olea and grass pollen with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma, from 12 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
CSMS: Combined Symptoms and Medication Score
Overall score of symptoms and medication throughout the trial. The minimum score is cero and maximum six, per day
Time frame: 12 months
Medication-free days
Number of days that the subjects need no medication
Time frame: 12 months
Symptom-free days
Number of days that the subjects have no symptom
Time frame: 12 months
Asthmatic exacerbations
Time elapsed until the first appearance of asthmatic exacerbations
Time frame: 12 months
Visual Analogue Scale (VAS)
Visual Analogue Scale in which the subject has to indicate in a straight line of 10cm how he/she feels regarding to his allergy symptoms. Being left side very bad and right side very well
Time frame: 12 months
Quality of life rhinitis test
Quality of life rhinitis test (ESPRINT-15)
Time frame: 12 months
Quality of life asthma test
Control of asthma by Asthma Control Quality questionnaire
Time frame: 12 months
Health resources
For each patient, the number of times that due to allergy symptoms has done the following will be counted: Have visited the GP, Have made an unscheduled visit to the specialist, Has gone to the emergency room, Has been hospitalized, Have needed to contact the doctor by phone
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The same solution and presentation as the active treatment, but without active ingredients
Cedt de Tarancón
Tarancón, Cuenca, Spain
RECRUITINGHospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain
COMPLETEDCentro Médico Iza
Tres Cantos, Madrid, Spain
RECRUITINGHospital Infanta Elena
Valdemoro, Madrid, Spain
RECRUITINGHospital Clínico Universitario Virgen de Arrixaca
El Palmar, Murcia, Spain
RECRUITINGPrivate Practice
Albacete, Spain
WITHDRAWNHospital Ntra. Sra. de Sonsoles
Ávila, Spain
RECRUITINGClinica Dermatologica Y Alergia
Badajoz, Spain
RECRUITINGHospital Quironsalud Clideba
Badajoz, Spain
RECRUITINGHospital Universitario Dexeus
Barcelona, Spain
RECRUITING...and 22 more locations
Time frame: 12 months
Immunological parameters
Analyses of total and specific IgE, specific Ig G4
Time frame: 12 months
Security parameters
Global rate and severity of AE per administration and per subject
Time frame: 12 months
Adverse Reactions
Local and systemic reactions and any medication administered for the treatment of AR
Time frame: 12 months