VALERGEN-combination of routes- Asthma-Adults-Phase II

Phase 2

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

• Registration Number: RPCEC00000298
• Lead Sponsor: ational Center of Bioproducts (BioCen)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 180

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.