Subcutaneous immunotherapy with PROLINEM-DS-Asthma- Adults-Fase II

Phase 2

Recruiting

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

• Registration Number: RPCEC00000278
• Lead Sponsor: ational Center of Bioproducts (BioCen)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-14
• Study Completion: 2024-04-08
• Results First Posted: 2024-08-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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.<br>