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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

SCIT-C-VALERGEN-DP-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 04.”

Acronym of Scientific Title:

SCIT-C-VALERGEN-DP-BT-Asthma-Adults-Phase II

Secondary indentifying numbers:

DA-EC2011011

Issuing authority of the secondary identifying numbers:

National Center of Bioproducts (BIOCEN)

Source(s) of monetary or material support:

National Center of Bioproducts (BIOCEN)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

14/03/2006

Reference number:

05.052.05.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Efren

Midle name:

Tomas

Last name:

Cruz Rodriguez

Medical Specialty :

Specialist of Frist Degree in Allergology

Affiliation:

Central Military Hospital Dr Luis Díaz Soto

Postal address:

2 ½ Monumenta Avenue

City:

Havana

País:

Not entered

Zip Code:

Cuba

Telephone:

+53-77680000

+53-77680057

+53-77680577

Email address:

efrein@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Central Military Hospital “Dr. Luis Díaz Soto”, November 13, 2010

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Suspended

Date of first enrollment:

22/05/2011

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Asthma

Intervention(s):

1. Group A (study group, combination therapy): VALERGEN-DP (right arm) and VALERGEN-BT (left arm). 2. Group B (control group, VALERGEN-BT): placebo (right arm) and VALERGEN-BT (left arm). 3. Group C (control group, VALERGEN-DP): VALERGEN-DP (right arm) and Placebo (left arm). In each group the treatment has an increasing phase with subcutaneous vaccination for 13 weeks and maintenance phase with subcutaneous vaccinationcn every 4 weeks until 12 months. - Increasing phase: 1. 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. 2. 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. 3. 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 6000 UB in group A and 3000 UB in groups B and C.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. 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. 3. 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. 4. Determination of Peak Expiratory Flow (PEF), (using standard meter of PEF: FERRARIS POCKETPEAK. Measurement time: twice daily, pre-treatment and during 12 months. 5. 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.

Key secondary outcomes:

1. Respiratory function classification (Criterion according PEF and PEF Variability: normal, mild obstruction, moderate obstruction, severe obstruction). Measurement time: pre-treatment, 6 y 12 months. 2. 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. 3. 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). Measurement time: weekly firsts 13 week and mnthly until 12 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

16 years

Maximum age:

45 years

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 color skin. 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.

Type of population:

Children and Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

120

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Maytee

Last Name:

Mateo Morejon

Specialty:

Bachelor in Biological Science, Master in Biotechnology Process

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Department

Postal Address:

Carretera Beltran Km 1 ½

City:

Bejucal, Mayabeque

País:

Cuba

Zip Code:

CP 13050, Box 6048

Telephone:

53-047-066-82201 al 07, ext of Allergen Department: 2100, 2101 y 2102.

Email :

mayteemm@biocen.cu

mayteemm@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Raul

Middle Name:

Lazaro

Last Name:

Castro Almarales

Specialty:

Specialist of Second Degree in Allergology

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Deparment

Postal Address:

Carretera Beltran Km 1 ½

City:

Bejucal, Mayabeque

País:

Cuba

Zip Code:

CP 13050, Box 6048

Telephone:

53-047-066-82201 al 07, Allergen Department, Ext.: 2100, 2101 and 2102

Email :

rcastro@biocen.cu

inmunoterapia@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000127

Date of Registration in Primary Registry:

2012-04-13

Record Verification Date:

2022/04/07

Next update date:

2023/04/07

Link to the spanish version:

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

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