Sublingual immunotherapy with VALERGEN-Asthma-Children-Phase II

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:

SLIT VALERGEN-Asthma-Children-Phase II

Scientific title:

Therapeutic effect and safety of the sublingual vaccines of house-dust mites with different treatment schedules in asthmatic children sensitive to those mites (Version 1.3).

Acronym of Scientific Title:

SLIT VALERGEN-Asthma-Children-Phase II

Secondary indentifying numbers:

GEC2012DPBT016

Issuing authority of the secondary identifying numbers:

National Center of Bioproducts (BioCen)

Source(s) of monetary or material support:

National Center of Bioproducts (BioCen)Cuban Ministry of Public Health

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 Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

11/04/2013

Reference number:

445/05-001-13-B

Principal investigator

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

First name:

Rafaela

Last name:

Andina Corrales

Medical Specialty :

Specialist of Frist Degree in Allergology

Affiliation:

Pediatric Hospital “Juan Manuel Márquez”

Postal address:

31 Avenue and 76 Street, Marianao

City:

Havana

País:

Cuba

Zip Code:

11500

Telephone:

+53-72609651

Email address:

rafaelaandina@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:

Havana, Pediatric Hospital Ángel Arturo Aballí, Emilia Rivero Pino, MD, Specialist of Frist Degree in Allergology

Havana, Pediatric Hospital Pedro Borras, Julia Eugenia Urbina Reynaldo, MD, Specialist of Frist Degree in Allergology

Havana, Center of Medical Surgical Investigations (CIMEQ), Omar Herrera Barrios, MD, Specialist of Frist Degree in Allergology

Havana, Clinic of 43, Omar Herrera Barrios, MD, Specialist of Frist Degree in Allergology

Holguín, Pediatric Hospital Octavio de la Concepción y la Pedraja, Sara Iris Romero Cuenca, MD, Specialist of Frist Degree in Allergology

Sancti Spíritus, Pediatric Docent Hospital José Martí, Álvaro Tomás González Marín, MD, Specialist of Second Degree in Allergology

Sancti Spíritus, University Policlinic Juan M. Martínez Puentes (Policlinic North), Álvaro González Iglesias, MD, Specialist of Frist Degree in Allergology

Sancti Spíritus, University Policlinic Manuel de Jesús Lara Cantero, Adriana Albert Montero, MD, Specialist of Frist Degree in Allergology

Sancti Spíritus, University Policlinic Ramón Balboa Monzón, Anabel Ruiz Cárdenas, MD, Specialist of Frist Degree in Allergology

Sancti Spíritus, Docent Policlinic of family Camilo Cienfuegos, Lidia Mabel Pérez Reyes, MD, Specialist of Frist Degree in Allergology

Sancti Spíritus, University Policlinic, Antonio Ávila Valdivia, Dra. Ropsalig Guerra Marzo, MD, Specialist of Frist Degree in Allergology

Camagüey, Pediatric Hospital Eduardo Agramonte Piña, Adianez Sugrañes Montalván, MD, Specialist of Frist Degree in Allergology

Santiago de Cuba, Pediatric South Docent Hospital Antonio María Béguez César, Caridad Sanchez Silot, MD, Specialist of Second Degree in Allergology

Research ethics committees:

Pediatric Hospital Juan Manuel Marquez, December 19, 2011, April 11, 2018

Pediatric Hospital Angel Arturo Aballi, December 7, 2011, April 3, 2018

Pediatric Hospital Pedro Borras, March 26, 2018

Center of Medical Surgical Investigations (CIMEQ), April 19, 2018

Clinic of 43, April 30, 2018

Pediatric Hospital Octavio de la Concepción y la Pedraja, April 2, 2018

Allergy Clinic of Policlinic Máximo Gómez Báez, April 10, 2018

Pediatric Docent Hospital José Martí, March 7, 2018

University Policlinic Juan M. Martínez Puentes (Policlinic North), March 5, 2018

University Policlinic Rudelsindo García del Rijo (Policlinic South), March 9, 2018

University Policlinic Manuel de Jesús Lara Cantero, March 20, 2018

University Policlinic Ramón Balboa Monzón, February 13, 2018

Docent Policlinic of family Camilo Cienfuegos, March 26, 2018

University Policlinic, Antonio Ávila Valdivia, March 26, 2018

Pediatric Hospital Eduardo Agramonte Piña, March 26, 2018

Pediatric South Docent Hospital Antonio María Béguez César, March 6, 2018

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

16/09/2013

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 has an increasing and maintenance phase. - Increasing phase: Sublingual Vaccination, daily for 23 days - Maintenance phase: Vaccination, sublingually, 2 times per week until completing 6 months Increasing Phase. 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. 1. Group A1: Schedule 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 2. Group A2: Schedule 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 3. Group A3: Schedule 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 4. Group B1: Schedule 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. 5. Group B2: Schedule 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 6. Group B3: Schedule 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 phase 2 drops, twice for week. In both groups, the second schedule 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):

1. 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. 2. 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: Pretreatment and 6 months. 3. Quality of life (PAQLQ(S)). Measuring time: Pretreatment and 6 months.

Key secondary outcomes:

1. Allergen-specific antibodies (antibody titer determination and IgG4 serum allergen-specific IgE in patients using an indirect ELISA). Measuring time: 6 months. 2. 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) - Seriousness 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). Measuring time: Daily during the frits 23 days and monthly until 6 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:

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 color skin. 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:

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:

Rafaela

Last Name:

Andina Corrales

Specialty:

Specialist 1st Degree in Allergology

Affiliation:

Juan Manuel Marquez Pediatric Hospital

Postal Address:

ave 31 esq 76, Marianao

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

72609651

Email :

rafaelaandina@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:

Mary

Middle Name:

Carmen

Last Name:

Reyes Zamora

Specialty:

Frist Degree Specialist in Immunology, Master in Clinical Trials

Affiliation:

National Center of Bioproducts (BIOCEN), Group of Clinical Trials.

Postal Address:

Carretera de Beltrán Km 1 ½, Bejucal

City:

Mayabeque

País:

Cuba

Zip Code:

32600

Telephone:

+53 47 682201-07 ext 1145 and 1147

Email :

mcarmen.reyes@biocen.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

27/12/2018

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:

2022/10/14

Next update date:

2023/10/14

Link to the spanish version:

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Sublingual immunotherapy with VALERGEN-Asthma-Children-Phase II

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