Asthma
Conditions
Interventions
Vaccination with PROLINEM DS (Dermatophagoides siboney allergen vaccine adjuvanted with Neisseria meningitidis proteoliposome) and Placebo by subcutaneous way:
Group 1:
Day 0: PROLINEM-DS 1,2 µg Der
Neisseria meningitidis
Immunotherapy, Active
Placebos
Injections, Subcutaneous
Prolinem DS
Sponsors
National Center of Bioproducts (BioCen)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Allergic asthmatic patients with a positive history of allergic symptoms caused by house dust. 2. Positive skin test to Dermatophagoides siboney with wheal diameter greater than or equal to 3 mm (VALERGEN-DS 20 000 BU / mL) and negative skin test Blomia tropicalis and Dermatophagoides pteronyssinus, or positive with a diameter lower than for DS. 3. Patients included in the study are patients diagnosed clinically as extrinsic asthmatics, which are classified as intermittent or persistent mild or moderate according to international guidelines for asthma (GINA, Global Initiative for Asthma) 4. Any color skin. 5. Patients express written consent to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients previously treated with immunotherapy with allergenic extracts in previous five years. 2. Patients classified as severe intermittent and persistent asthmatics according to the guide International Asthma Initiative (GINA). 3. Diagnosed autoimmune disease of any kind. 4. Generalized severe eczema. 5. Patients with a diagnosis of tumor disease. 6. Patients under treatment with beta-blockers. 7. Patients where the use of adrenaline is contraindicated (arterial hypertension). 8. Pregnancy and lactation. 9. Patients who required treatment at least one year before the study immunostimulant or immunosuppressant (except corticosteroids), including interferons, cyclosporin A and natural immunomodulators (Vimang, Biomodulin, etc.). 10. Patients who have suffered from bacterial meningitis in the last year. 11. Patients with a history of psychiatric disorders. 12. Patients who do not wish to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Symptom score: Dyspnea, cough, expectoration, wheeze and tightness (four-digit score: 0 = non symptom, 1 = mild, 2 = moderate, 3 = severe). Measuring time: pre-treatment, and day 42, 3, 8 and 14 months. 2. Consumption of medications (three-digit score: 0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = corticosteroids). Measuring time: pre-treatment, and day 42, 3, 8 and 14 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Expiratory lung function (spirometer forced technique with portable spirometer (DATOSPIR-70). Determine the Forced Vital Capacity (FVC), and Forced Expiratory Volume in one second (FEV1). Both are expressed as a percentage of the theoretical reference value calculated according to body weight of the patient). Measuring time: pre-treatment, 42 days, 3, 8, and 14 months. 2. Skin reactivity: (value Ch10: relative allergen concentration causing in the patient a similar wheal to induced wheal by a HCL histamine solution (10 mg/mL= 54.3 mmol/L de Histamina base)). Measuring time: pre-treatment, 42 days, 3, 8, and 14 months. 3. Quality of life (Asthma Questionnaire Life Quality (Juniper)). Measuring time: Pretreatment and 3, 8, and 14 months. 4. Allergen-specific antibodies (antibody titer determination and IgG4 serum allergen-specific IgE in patients using an indirect ELISA). Measuring time: pre-treatment, 42 days, 3, 8, and 14 months. 5. Adverse events-AE (- Occurrence of some AE in the patient (Yes, No); - Description of the AE (Name of adverse event); - According to available previous information (Unexpected, Expected); - According to its localization the expected AE (World Allergy Organization Criterion: local and systemic AE (0= Nonspecific Symptoms, I= Mild systemic reactions, II= Moderate systemic reactions, III= Severe (nonlife-threatening) systemic reactions, IV= Anaphylactic shock)); - Duration of the AE (Difference of dates between star and stop of event);- Intensity of the AE (Light, Moderate, Severe); - Seriousness of the AE (Serious, No serious); - Attitude regarding the treatment in study (No changes, Dose modification, Temporary interruption, Definitive interruption of the treatment in study); - Result of the AE (Recovered, Improved, Persists, Sequels); - Causality Relationship (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated)). Measuring time: days 0, 14, 28, 42, 56, months 3, 5, 7, 8, 10, 12 and 14. | — |
Countries
Cuba
Contacts
Public ContactMirta Álvarez Castelló
Calixto García Hospital
Outcome results
None listed