Pharmacovigilance-VALERGEN-Asthma

Phase 4

Completed

• Conditions: Asthma.; Asthma; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

• Registration Number: RPCEC00000231
• Lead Sponsor: ational Center of Bioproducts (BIOCEN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2108

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified