Sublingual immunotherapy with VALERGEN-Asthma-Children-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.

Scientific title:

Therapeutic effect and security of the sublingual vaccines of house-dust mites, with different posologicals regimens in asthmatic children sensitive to those mites (Version 1).

Secondary indentifying numbers:

DA-EC2012012

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 :

11/04/2013

Reference number:

445/05-001-13B

Principal investigator

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

First name:

Pediatric Hospital “William Soler”, Concepción Insua, MD. Specialist of 1er Degree in Immunology . Pediatric Hospital “Juan Manuel Marquez”, Rafaela Andina Corrales, MD. Specialist of 1er Degree in Allergology. Pediatric Hospital “Angel Arturo Aballi”, Marlene Jiménez Frandin MD. Specialist of 1er Degree in Allergology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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. In the protocol all the investigators are considered principal investigators.

Research ethics committees:

Pediatric Hospital William Soler, September 27, 2012 Pediatric Hospital Juan Manuel Marquez, October 15, 2012 Pediatric Hospital Angel Arturo Aballi, October 3, 2012

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

16/10/2013

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):

Group A: VALERGEN-DP Group B: VALERGEN-BT In each group there are 3 schemes. In each scheme, the treatment is presented as: - Increasing Phase: Vaccination, sublingually, daily for 23 days - Maintenance phase: Vaccination, sublingually, 2 times per week until completing 6 months Increasing Phase. The vaccine will be administered in volumes of 1, 2, 3, 4, 6, 8 and 10 drops depending on day 1, 2, 3, 4, 5, 6 and 7 of each week, respectively. Group A Scheme 1. It begins in the concentration of 2UB/mL Week 1. Day 1 to 7. Concentration of 2 BU / mL Week 2. Day 8 to 14. Concentration of 20 BU / mL Week 3. Day 15 to 21. Concentration of 200 BU / mL Week 4. Day 22 and 23. Concentration of 2000 BU / mL Group A Scheme 2. It begins in the concentration of 20 UB/mL Week 1. Day 1 to 7. Concentration of 20 BU / mL Week 2. Day 8 to 14. Concentration of 200 BU / mL Week 3. Day 15 to 21. Concentration of 2000 BU / mL Week 4. Day 22 and 23. Concentration of 20000 BU / mL Group A Scheme 3. It begins in the concentration of 200 UB/mL Week 1. Day 1 to 7. Concentration of 200 BU / mL Week 2. Day 8 to 14. Concentration of 2000 BU / mL Week 3. Day 15 to 21. Concentration of 20000 BU / mL Week 4. Day 22 and 23. Concentration of 200000 BU / mL Group B Scheme 1. It begins in the concentration of 2UB/mL Week 1. Day 1 to 7. Concentration of 2 BU / mL Week 2. Day 8 to 14. Concentration of 20 BU / mL Week 3. Day 15 to 21. Concentration of 200 BU / mL Week 4. Day 22 and 23. Concentration of 2000 BU / mL Group B Scheme 2. It begins in the concentration of 20 UB/mL Week 1. Day 1 to 7. Concentration of 20 BU / mL Week 2. Day 8 to 14. Concentration of 200 BU / mL Week 3. Day 15 to 21. Concentration of 2000 BU / mL Week 4. Day 22 and 23. Concentration of 20000 BU / mL Group B Scheme 3. It begins in the concentration of 200 UB/mL Week 1. Day 1 to 7. Concentration of 200 BU / mL Week 2. Day 8 to 14. Concentration of 2000 BU / mL Week 3. Day 15 to 21. Concentration of 20000 BU / mL Week 4. Day 22 and 23. Concentration of 200000 BU / mL Maintenance phase. It begins when the patient reaches the maximum tolerated dose (range between 2 and 400 000 BU / mL). The maximum tolerated dose is defined as the dose at which no systemic reactions were observed. For patients receiving the whole increasing phase, the maintenance dose will be 200, 2000 and 20000 UB as Scheme 1, 2 or 3 respectively. In all cases, be applied at this stage 2 drops, 2 times per week. In both groups, the second scheme is the control group.

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):

Symptom score: Dyspnea, cough, expectoration, wheeze and tightness (four-digit score: 0 = non symptom, 1 = mild, 2 = moderate, 3 = severe). Measuring time: daily during 6 months. Consumption of medications (three-digit score: 0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = corticosteroids)). Measuring time: daily during 6 months. Determination of Peak Expiratory Flow (PEF), (using standard meter of PEF: FERRARIS POCKETPEAK Measuring time: twice a day during 6 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)). Measuring time: 6 months. Quality of life (PAQLQ(S)). Measuring time: 6 months.

Key secondary outcomes:

Allergen-specific antibodies (antibody titer determination and IgG4 serum allergen-specific IgE in patients using an indirect ELISA). Measuring time: 6 months. Adverse events (AE). Measuring time: during 6 months. - 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 beginning and termination of event) - 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) - Relationship of causation of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated)

Selection criterias

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

Gender:

Male/Female

Minimum age:

5 years

Maximum age:

15 years

Inclusion criteria:

1. Asthmatic allergic patients with a clinical positive history of allergic symptoms provoked by the house-dust. 2. It proves cutaneous positive with the allergen extracts of D. pteronyssinus or B. Tropicalis to 20 000 UB / mL Keeping in mind that the cutaneous answer for the respective allergen is predominant when compared to that obtained with other mites, the patients will be included in one of the two groups: A: D. pteronyssinus, B: B. tropicalis) 3. Patients clinically diagnosed as extrinsic asthmatics that, according to the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Agreement on Asthma Diagnosis and Treatment. 4. Age between 5 and 15 years. 5. Any sex and race. 6. Patient whose parents or tutors express their informed consent in writing to participate in the trial

Exclusion criteria:

1. Patients on allergenic extract immunotherapy during the two years before. 2. Patients classified as intermittent or severe persistent asthmatics after being interviewed. 3. Patients with a diagnostic of an autoimmune disease. 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 needed,at least a year before the study, immunostimulant or immunosuppressor treatment (no corticosteroids) including interferon and cyclosporine A. 10. Pregnancy and breastfeeding (will be perform pregnancy test to females after menarche). 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

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:

300

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:

Mary

Middle Name:

Carmen

Last Name:

Reyes Zamora

Specialty:

IGM and Immunology

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Department

Postal Address:

Carretera de Beltrán Km 1 ½,

City:

Bejucal, Mayabeque

País:

Cuba

Zip Code:

CP 13050, Box 6048

Telephone:

53-047-066-82201 - 07, ext: 2100, 2101 y 2102.

Email :

maryreyes@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:

Raúl

Middle Name:

Lázaro

Last Name:

Castro Almarales

Specialty:

IGM and Allergy

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Deparment

Postal Address:

Carretera de Beltrán Km 1 ½

City:

Bejucal, Mayabeque

País:

Cuba

Zip Code:

CP 13050, Box 6048

Telephone:

53-047-066-82201 - 07, ext: 2100, 2101 y 2102.

Email :

rcastro@biocen.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:

RPCEC00000125

Date of Registration in Primary Registry:

2012-04-02

Record Verification Date:

2012-03-30 20:00

Link to the spanish version:

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Sublingual immunotherapy with VALERGEN-Asthma-Children-Phase II

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