RPCEC00000231CompletedPhase 4
Vigilance of the effectiveness and safety of the VALERGEN vaccines in the treatment of asthma - PV-VALERGEN-Asthma
ational Center of Bioproducts (BIOCEN)0 sites2,108 target enrollmentStarted: January 27, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 2,108
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
Eligibility Criteria
- Ages
- 5 years to one (—)
- Sex
- All
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
- •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.
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