Asthma
Conditions
Interventions
Group A: VALERGEN DP
Group B: VALERGEN DS
Group C: VALERGEN BT. In each group there are 3 schemes.
Scheme 1: Subcutaneous route (SC)
Scheme 2: Sublingual route (SL)
Scheme 3: Subcutaneous route (SC) in increasing phase and, sublingual route (
Injections, Subcutaneous
allergenic extract
Blomia tropicalis
Dermatophagoides pteronyssinus
Dermatophagoides siboney
VALERGEN-BT
VALERGEN DP
VALERGEN 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 one of the three mites greater than or equal to 3 mm (VALERGEN DP, VALERGEN DS or VALERGEN BT, 20 000 UB / mL) and skin test negative to the other two or positive, but with a smaller diameter. 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. Age between 18 and 50. 5. Patients express written consent to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients previously treated with immunotherapy with allergenic extracts in the previous five years. 2. Patients classified as Intermittent or severe persistent asthma. 3. Diagnosed autoimmune disease of any kind. 4. Generalized severe eczema. 5. Patients with tumor disease. 6. Patients treated with beta-blockers. 7. Patients where the use of adrenaline is contraindicated (hypertension). 8. Pregnancy and lactation (pregnancy tests will be performed on females). 9. Patients at least one year prior to the study required immunostimulant or immunosuppressive treatment (except corticosteroids), including interferons, cyclosporin A and natural immunomodulators (Vimang Biomodulina) 10. Patients with a history of psychiatric disorders that compromise data collection and adherence to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms and medication for asthma [Symptoms rating (shortness of breath, cough, sputum, wheezing and chest tightness). Each symptom 1 point, maximum of 5 points per day. Points will be added by the intensity 0: symptoms disappear spontaneously, 1: If necessary self-administered home therapy (tablets, syrups and sprays pressurized bronchodilators), 2: If the patient will need to attend the consultation of the research team or the emergency guard of any instance, 3: If the patient requires hospitalization. Need medication Scoring: 3-point scale (0 = no use, 1 = use of beta-2 agonists, methylxanthines, ephedrine, adrenaline, inhaled steroids 2 = use of systemic steroids). The compound variable of symptoms and medication will be calculated as the simple sum of both scores. Measuring time: daily, during the month before treatment start and, during the 6 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms and medication for rhinitis: Symptom score (Pruritus, Secretion, Nasal obstruction, Sneezing, Itching / Red eyes, Tearing). Each symptom evaluated can reach a value of 0 to 3 points according to: 0 points: no symptoms, 1 point: slight symptoms (signs / symptoms clearly present, but minimal discomfort, well tolerated), 2 points: moderate symptoms (definite awareness of signs / symptoms that are annoying but tolerated), 3 points: severe symptoms (signs / symptoms that are difficult to tolerate, interfere with activities of daily living and / or sleep). Score for medication need: 1 point: Oral or topical H1 antihistamines, 2 points: Topical corticosteroids, 3 points: Oral corticosteroids. The variable composed of symptoms and medication will be calculated as the simple sum of both scores. Measurement time: daily, during the 30 days before treatment star and, during the 6 months of treatment. 2. Allergen-specific skin reactivity (Ch10, allergen concentration equivalent to a wheal area equal to that produced by Histamine HCl 10 mg / mL). Measurement time: At baseline and, 6 months. 3. Determination of Peak Expiratory Flow (PEF), using standard meter of PEF Measuring time: twice a day during the 30 days before treatment start and, during the 6 months of treatment 4. Quality of life (Quality of life questionnaire AQLQ (S), JUNIPER). Measuring time: At baseline and, 6 months. 5. Control test of Allergic Rhinitis and Asthma (According to the CARAT questionnaire) Measurement time: At baseline and, 6 months. 6. Allergen-specific antibodies (Values of IgE and IgG4 using ELISA technique). Measuring time: At baseline and, 6 months. 7. Adverse events-AE (Occurrence of AE (Yes, No); Type of AE (Name of AE according to clinical manifestation); Localization of the AE (WAO classification: Local, Systemic Grade 1, Systemic Grade 2, Systemic Grade 3, Systemic Grade 4, Systemic Grade 5); Time of appearance (Time from the administration of the drug until the appearance of the | — |
Countries
Cuba
Contacts
Public ContactIglermys Figueroa Garcia
Surgical Clinical Hospital “Hermanos Ameijeiras”.
Outcome results
None listed