Asthma.
Conditions
Interventions
Guidelines prescribed by the manufacturer (Informative sheet of VALERGEN) for VALERGEN-DP, VALERGEN-DS Y VALERGEN-BT according to administration route, subcutaneous or sublingual.
Sublingual route: T
Immunotherapy, Active
Injections, Subcutaneous
VALERGEN-DP,
VALERGEN-DS,
VALERGEN-BT,
allergenic extract,
Dermatophagoides siboney,
Blomia tropicalis
Sponsors
National Center of Bioproducts (BIOCEN)
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed diagnosis of intermittent asthma and mild to moderate persistent, associated with allergic sensitization to dust mites Dermatophagoides pteronyssinus, Dermatophagoides Siboney or Blomia tropicalis, indicating medical VALERGEN immunotherapy vaccines according manufacturer's instructions. 2. Patients monosensitized and polysensitized. 3. Both gender. 4. Over 5 years of age. 5. Patients with the ability to answer to interview questions or carer/tutor who can answer for patient.
Exclusion criteria
Exclusion criteria: 1. Patients without the capacity to answer to interview questions or carer / tutor who can answer for patient. 2. Patients who can not be located for follow-up phone (with SLIT treatment) 3. Patients unwilling to provide information. 4. Patients with contraindications for the application of immunotherapy with VALERGEN vaccines, according to the manufacturer's instructions. 5. Patients previously treated with immunotherapy with allergenic extracts in the two previous years. 6. Patients who do not commit to regularly attend follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Frequency of asthma attacks (Occurrence of crises in the past 14 days. Is calculated by dividing the number of days with crisis from 14-range between 0 and 1). Measuring time: at baseline, 6 and 12 months. 2. Severity of asthma attacks (Considering where the patient resolved the crisis in the last 14 days where 0: not present crisis and these were resolved at home, 1: all crises were resolved at home, but was required broncodilatadore, 2 use: at least one crisis required the use of inhaled corticosteroids and / or oral at home or required home care in emergency, 3: hospitalization is required). Measuring time: at baseline, 6 and 12 months. 3. Consumption of medications Keeping in mind the consumption of medications in the last 14 days (0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = inhaled corticosteroids, 3= oral and injected corticosteroids). Measuring time: at baseline, 6 and 12 months. 4. Quality of life (according to Asthma-Junniper Quality of Life Questionnaire AQLQ(S): seven-digit score (1 = maxim deteriorate to 7= no deteriorate)). Measuring time: at baseline, 6 and 12 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 and 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 beginning and termination of event) - Intensity of the AE (Light, Moderate, Severe) - Graveness of the AE (Serious, No Serious) - Attitude regarding the treatment in study (without changes, dose modification, temporary or definitive interruption of the treatment in study) - Result of the AE (recovered, improved, it persists or sequels) - Caus | — |
Secondary
| Measure | Time frame |
|---|---|
| General Criteria for Improvement (Based on the score of frequency and severity of asthma attacks, and drug use, quality of life index: better, same or worse). Measuring time: 6 and 12 months. | — |
Countries
Cuba
Contacts
Public ContactMaytee Mateo Morejon
National Center of Bioproducts (BIOCEN), Allergen Department
Outcome results
None listed