Revisions for Pharmacovigilance-VALERGEN-Asthma | Registro Público Cubano de Ensayos Clínicos

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Pharmacovigilance-VALERGEN-Asthma

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:

PV-VALERGEN-Asthma

Scientific title:

Vigilance of the effectiveness and safety of the VALERGEN vaccines in the treatment of asthma

Acronym of Scientific Title:

PV-VALERGEN-Asthma

Secondary indentifying numbers:

DA-EC2012013

Issuing authority of the secondary identifying numbers:

National Center of Bioproducts (BIOCEN)

Source(s) of monetary or material support:

National Center of Bioproducts (BIOCEN) Ministry of Public Health (MINSAP)

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:

Others instances

Other regulatory instances:

Center for Development of Pharmacoepidemiology

Authorization date :

26/09/2010

Reference number:

Not applicable (the approval of the Scientific committee no has a number)

Principal investigator

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

First name:

Maytee

Last name:

Mateo Morejon

Medical Specialty :

Bachelor in Biological Sciences, Master in Biotechnology Process

Affiliation:

National Center of Bioproducts (BioCen)

Postal address:

Carretera Beltran Km 1 ½

City:

Bejucal, Mayabeque

Country:

Cuba

Zip Code:

ZC: 13050, Box 6048

Telephone:

+53-047682201 ext. 2102

Email address:

mayteemm@biocen.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:

Mayabeque, Hospital "Aleida Fernandez Charduet", Juan Carlos Castro Cuello, MD. First degree specialist in allergology

Mayabeque, Polyclinic "Turcios Lima", Doris Diaz, MD. First degree specialist in allergology

Havana, Pediatric hospital "William Soler", Alexander Ciria Martin, MD. First degree specialist in allergology

Havana, Hospital "Salvador Allende", Ada del C. Castillo Mendez, MD. First degree specialist in allergology

Havana, Pediatric hospital "Cerro", Roberto Aguila, MD. First degree specialist in allergology

Havana, Hospital "Enrique Cabrera", Raima de los Milagros Tase Vila, MD. First degree specialist in allergology

Havana, Hospital "Calixto Garcia", Mercedes Ronquillo Diaz, MD. First degree specialist in allergology

Havana, Teaching hospital "Joaquin Albarran", Rosa Maria Naranjo Robalino, MD. First degree specialist in allergology

Havana, Peaditric hospital "Angle Arturo Aballi", Marlene Jimenez Frandin, MD. First degree specialist in allergology

Havana, Pediatric hospital "Centro Habana", Magdalena Cuevas Hernandez, MD. First degree specialist in allergology

Havana, Military hospital "Carlos J. Finlay", Yanet Rodriguez, MD. First degree specialist in allergology

Havana, Hospital "Hermanos Amejeiras", Iglermis Figueroa Garcia, MD. First degree specialist in allergology

Havana, Hospital "Manuel Fajardo", Grizel de la Caridad Diaz Rodriguez, MD. First degree specialist in allergology

Havana, Polyclinic "Cristobal Labra", Julia Eugenia Urbina Reynaldo, MD. First degree specialist in allergology

Matanzas, Hospital "Faustino Perez", Kenia Espinosa Mendez, MD. First degree specialist in allergology

Sancti Spíritus, Provincial hospital "General Camilo Cienfuegos", Tania Perez Jimenez, MD. First degree specialist in allergology

Ciego de Avila, Hospital "Roberto Rodriguez", Nelva E. Gonzalez Cedre, MD. First degree specialist in allergology

Camaguey, Provincial hospital of Camaguey, Maria Morales Menendez, MD. First degree specialist in allergology

Camaguey, Policlínico Previsora, Olimpio Rodriguez Santos, MD. First degree specialist in allergology

Camaguey, Hospital "Amalia Simoni", Silma Perez Iglesias, MD. First degree specialist in allergology

Camaguey, Polyclinic of pediatric specialities of Camaguey, Jose Victor Gonzalez Abreu, MD. First degree specialist in allergology

Las Tunas, Polyclinic "Gustavo Aldereguia Lima", Edgar Rodriguez Gonzalez, MD. First degree specialist in allergology

Las Tunas, Polyclinic "Guillermo Tejas Silva", Maura Avila Castro, MD. First degree specialist in allergology

Santiago de Cuba, Medical specialities clinic, Ana Olga del Arco Perez, MD. First degree specialist in allergology

Holguin, Hospital "Octavio de la Concepcion y la Pedraja", Vilma Rosa Perez Rodriguez, MD. First degree specialist in allergology

Cienfuegos, Pediatric hospital of Cienfuegos, Andres Osquel Benitez Goitizolo, MD. First degree specialist in allergology

Research ethics committees:

Center for Development of Pharmaco-epidemiology, September 26, 2010 (Scientific committee)

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

01/02/2011

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.

Health condition(s) code:

Asthma

Bronchial Diseases

Lung Diseases, Obstructive

Lung Diseases

Respiratory Tract Diseases

Respiratory Hypersensitivity

Hypersensitivity, Immediate

Hypersensitivity

Immune System Diseases

Environmental Illness

Intervention(s):

Guidelines prescribed by the manufacturer (Informative sheet of VALERGEN) for VALERGEN-DP, VALERGEN-DS Y VALERGEN-BT according to administration route, subcutaneous or sublingual. Sublingual route: Treatment has 2 phases: Increasing phase administration daily for 23 days and maintenance phase (twice for week, Monday a Friday) until 12 months. Increasing phase: Day 1 to 7: Concentration of 20 UB/mL. Day 8 to 14: Concentration of 200 UB/mL. Day 15 to 21: Concentration of 2000 UB/mL. Day 22 to 23: Concentration of 20000 UB/mL. Maintenance phase. It starts when the patient reaches the maximum tolerated dose (recommended between 600 and 2000 UB/mL). The maximum tolerated dose is the dose at which no systemic reactions grade I-IV. For patients receiving complete the increasing phase, the maintenance dose is 2000 UB. Subcutaneous route: Treatment has 2 phases: Increasing phase administration weekly for 13 weeks and maintenance phase every 4 weeks until 12 months. Increasing phase: Week 1 to 3: Concentration of 20 UB/mL. Week 4 to 6: Concentration of 200 UB/mL. Week 7 to 10. Concentration of 2000 UB/mL. Week 11 to 13: Concentration of 20000 UB/mL. Maintenance phase. It starts when the patient reaches the maximum tolerated dose (recommended between 800 and 6000 UB/mL). The maximum tolerated dose is the dose at which no are systemic reactions grade I-IV. For patients receiving complete the increasing phase, the maintenance dose is 6000 UB. It will accepted change for the dose indicated in the prospectus, which are characteristic of allergenspecific immunotherapy. The physician will choose the route of administration sublingual or subcutaneous whichever seems most appropriate for each patient.

Intervention code:

Dermatophagoides pteronyssinus

Pyroglyphidae

Sublingual Immunotherapy

Desensitization, Immunologic

Immunotherapy, Active

Injections, Subcutaneous

Administration, Sublingual

Intervention keyword:

VALERGEN-DP, VALERGEN-DS, VALERGEN-BT, allergenic extract, Dermatophagoides siboney, Blomia tropicalis

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. Frequency of asthma attacks (Occurrence of crises in the past 14 days. Is calculated by dividing the number of days with crisis from 14-range between 0 and 1). Measuring time: at baseline, 6 and 12 months. 2. Severity of asthma attacks (Considering where the patient resolved the crisis in the last 14 days where 0: not present crisis and these were resolved at home, 1: all crises were resolved at home, but was required broncodilatadore, 2 use: at least one crisis required the use of inhaled corticosteroids and / or oral at home or required home care in emergency, 3: hospitalization is required). Measuring time: at baseline, 6 and 12 months. 3. Consumption of medications Keeping in mind the consumption of medications in the last 14 days (0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = inhaled corticosteroids, 3= oral and injected corticosteroids). Measuring time: at baseline, 6 and 12 months. 4. Quality of life (according to Asthma-Junniper Quality of Life Questionnaire AQLQ(S): seven-digit score (1 = maxim deteriorate to 7= no deteriorate)). Measuring time: at baseline, 6 and 12 months. 5. Adverse events-AE (- 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, it persists or sequels) - Causality Relationship of the AE (1.Very Likely, 2.Likely, 3.Possible, 4.Non-Improbable, 5.No related, 6.No evaluable). Measuring time: weekly in the first months, monthly from months 2 until months 12.

Key secondary outcomes:

General Criteria for Improvement (Based on the score of frequency and severity of asthma attacks, and drug use, quality of life index: better, same or worse). Measuring time: 6 and 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:

5 years

Maximum age:

None

Inclusion criteria:

1. Patients with confirmed diagnosis of intermittent asthma and mild to moderate persistent, associated with allergic sensitization to dust mites Dermatophagoides pteronyssinus, Dermatophagoides Siboney or Blomia tropicalis, indicating medical VALERGEN immunotherapy vaccines according manufacturer's instructions. 2. Patients monosensitized and polysensitized. 3. Both gender. 4. Over 5 years of age. 5. Patients with the ability to answer to interview questions or carer/tutor who can answer for patient.

Exclusion criteria:

1. Patients without the capacity to answer to interview questions or carer / tutor who can answer for patient. 2. Patients who can not be located for follow-up phone (with SLIT treatment) 3. Patients unwilling to provide information. 4. Patients with contraindications for the application of immunotherapy with VALERGEN vaccines, according to the manufacturer's instructions. 5. Patients previously treated with immunotherapy with allergenic extracts in the two previous years. 6. Patients who do not commit to regularly attend follow-up visits.

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

Target sample size:

2108

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 Sciences, Master in Biotechnology Process

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Department

Postal Address:

Carretera de Beltran Km 1 ½

City:

Bejucal, Mayabeque

Country:

Cuba

Zip Code:

ZP 13050, Box 6048

Telephone:

+53-047066-82201 al 07, Allergen Department Ext 2100, 2101 y 2102.

Email :

mayteemm@biocen.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:

First degree specialist in Immunology. Master in clinical trials

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Department

Postal Address:

Carretera de Beltran Km 1 ½

City:

Bejucal, Mayabeque

Country:

Cuba

Zip Code:

ZP 13050, Box 6048

Telephone:

+53-047682201 al 07, Allergen Department Ext: 2100, 2101 y 2102.

Email :

mary.reyes@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:

RPCEC00000231

Date of Registration in Primary Registry:

27/01/2017

Record Verification Date:

2017/01/29

Next update date:

2018/01/29

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Pharmacovigilance-VALERGEN-Asthma

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