Combined immunotherapy VALERGEN-DP and VALERGEN-BT-Asthma-Adults-Phase II

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000127
• Date of registration: 13/04/2012
• Primary sponsor: National Center of Bioproducts (BIOCEN)
• Public title: Combined immunotherapy VALERGEN-DP and VALERGEN-BT-Asthma-Adults-Phase II
• Scientific title: “Clinical trial with allergenic extracts Dermatophagoides pteronyssinus (VALERGEN-DP) and Blomia tropicalis (VALERGEN-BT) by subcutaneous therapeutic use in sensitized asthmatic adults. Version 4.”
• Date of first enrolment: 22/05/2011
• Target sample size: 120
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000127-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Raul Castro Almarales
• Affiliation: National Center of Bioproducts (BIOCEN), Allergen Deparment

• Name: Maytee Mateo Morejon
• Affiliation: National Center of Bioproducts (BIOCEN), Allergen Department

Key inclusion & exclusion criteria

Inclusion criteria: 1. Asthmatic allergic patients with positive responses during the preliminary survey in the following aspects: family and personal history of atopy, clinical symptoms only triggered when exposed to dust at home, mainly indoors, when getting up in the morning or going to bed at night. 2. Skin test positive with similar diameter (difference not mayor of 2 mm) to allergenic extracts of D. pteronyssinus and B. tropicalis, VALERGEN, 20,000 BU/ml. 3. Patients included in the study will be patients clinically diagnosed as extrinsic asthmatics who, according the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Consensus on Asthma Diagnosis and Treatment (GINA). 4. Age between 16 and 45 years. 5. Any sex and race. 6. Patients expressing their consent in writing to participate in clinical trial.
Exclusion criteria: 1. Patients on allergenic extract immunotherapy during the two preceding years. 2. Patients classified as intermittent or severe persistent asthmatics after being interviewed. 3. Patients with a diagnosed autoimmune disease of any kind 4. Generalized severe eczema. 5. Patients with diagnosed tumoral disease. 6. Patients on betablocker treatment. 7. Patients with psychiatric disorders. 8. Patients not cooperating with treatment. 9. Patients who, at least one year before the study, needed immunostimulant or immunosuppressor treatment (no corticosteroids), including interferon and cyclosporine A. 10. Pregnancy and breastfeeding. 11. Adrenalin-contraindicated patients (high blood pressure). 12. Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules.

Age minimum: 16 years
Age maximum: 45 years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Group A (study group, combination therapy): VALERGEN-DP (right arm) and VALERGEN-BT (left arm) Group B (control group, VALERGEN-BT): placebo (right arm) and VALERGEN-BT (left arm). Group C (control group, VALERGEN-DP): VALERGEN-DP (right arm) and Placebo (left arm). In each group the treatment has 2 phases: - Increasing phase: Vaccination, subcutaneously, weekly for 13 weeks - Maintenance phase: Vaccination subcutaneously every 4 weeks until 12 months. Increasing phase Group A Week 1 to 3. Concentration of 10 UB/mL VALERGEN-DP and 10 BU / mL VALERGEN-BT Week 4 to 6. Concentration of 100 UB/mL VALERGEN-DP and 100 BU / mL VALERGEN-BT Week 7 to 10. Concentration of 1000 UB/mL VALERGEN-DP and 1000 BU / mL VALERGEN-BT Week 11 to 13. Concentration of 10000 UB/mL VALERGEN-DP and 10000 BU / mL VALERGEN-BT Group B. Week 1 to 3. Concentration of 10 UB/mL VALERGEN-BT and Placebo Week 4 to 6. Concentration of 100 UB/mL VALERGEN-BT and Placebo Week 7 to 10. Concentration of 1000 UB/mL VALERGEN-BT and Placebo Week 11 to 13. Concentration of 10000 UB/mL VALERGEN-BT and Placebo Group C. Week 1 to 3. Concentration of 10 UB/mL VALERGEN-DP and Placebo Week 4 to 6. Concentration of 100 UB/mL VALERGEN-DP and Placebo Week 7 to 10. Concentration of 1000 UB/mL VALERGEN-DP and Placebo Week 11 to 13. Concentration of 10000 UB/mL VALERGEN-DP and Placebo Maintenance phase. It starts when the patient reaches the maximum tolerated dose (recommended between 800 and 6000 UB/mL). The maximum tolerated dose is defined as the dose at which no systemic reactions were observed grade I-IV. For patients receiving complete the increasing phase, the maintenance dose is 6000UB in group A and 3000UB in groups B and C.

Primary Outcome(s)

Symptom score: Dyspnea, cough, expectoration, wheeze and tightness (four-digit score: 0 = non symptom, 1 = mild, 2 = moderate, 3 = severe). Measurement time: daily, pre-treatment and during 12 months. 2. Consumption of medications (three-digit score: 0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = corticosteroids)). Measurement time: daily, pre-treatment and during 12 months. Determination of Peak Expiratory Flow (PEF), (using standard meter of PEF: FERRARIS POCKETPEAK Measurement time: twice daily, pre-treatment and during 12 months. Skin reactivity: (value Ch10: relative allergen concentration causing in the patient a similar wheal to induced wheal by a HCL histamine solution (10 mg/mL= 54.3 mmol/L de Histamina base)). Measurement time: pre-treatment, 6 and 12 months. Quality of life (according to AQLQ(S) Asthma Quality of Life Questionnaire: seven-digit score (1 = maxim deteriorate to 7= no deteriorate)). Measurement time: pre-treatment, 6 and 12 months.

Secondary Outcome(s)

Respiratory function classification (Criterion according PEF and PEF Variability: normal, mild obstruction, moderate obstruction, severe obstruction). Measurement time: pre-treatment, 6 y 12 months. General evaluation (based on symptom-medication score, respiratory function, skin reactivity, quality of life: better, equal, worse). Measurement time: pre-treatment, 6 y 12 months. Allergen-specific antibodies (Measuring serum allergen-specific antibodies IgG4 and IgE level in the patients using indirect ELISA). Measurement time: pre-treatment, 6 and 12 months. Adverse events (AE). Measurement time: during 12 months according to the treatment scheme. - 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 the beginning and the end of the AE) - 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, Persists or sequels) - Causal Relationship of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated)

Secondary ID(s)

DA-EC2011011

Source(s) of Monetary Support

National Center of Bioproducts (BIOCEN)

Secondary Sponsor(s)

Not applicable