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Efficacy of VALERGEN-BT sublingual vaccine in asthmatic adults.
View current
Revisions
Comparing two revisions:
15 April 2020 - 6:38pm
by BIOCEN
30 April 2020 - 4:27pm
by BIOCEN
< previous diff
next diff >
Changes to
Authorization date
-
2005
-
05
-
27 04
:00:00
+
2017
-
02
-
17 00
:00:00
Changes to
Clinical sites
-
Not applicable
+
Havana, Joaquín Albarrán Hospital , MD Rosa Naranjo, 1st Degree Specialist in Allergology
+
Havana, 43 Clinic, MD Omar Herrera Barrios, 1st degree Allergology and 2nd Degree in Internal Medicine
+
Sancti Spíritus, Maternal and Child Surgical Clinical Hospital Camilo Cienfuegos, MD Niurka Martínez Díaz, 1st Degree Specialist in Allergology
+
Sancti Spíritus, University Polyclinic Juan M. Martínez Puentes (Pol. Norte), MD Álvaro González Iglesias,1st Degree Specialist in Allergology
+
Sancti Spíritus, University Polyclinic Antonio Ávila Valdivia, MD Ropsalig Guerra Marzo,1st Degree Specialist in Allergology
+
Sancti Spíritus, University Polyclinic Manuel de Jesús Lara Cantero,MD Adriana Albert Montero. 1st Degree Specialist in Allergology
+
Camagüey, Provincial Hospital Manuel Ascunce Domenech, MD Osaida Calderin Marin. 1st Degree Specialist in Allergology
+
Camagüey, Amalia Simoni Hospital, MD. Edilberto Machado del Risco. 1st Degree Specialist in Allergology
Changes to
Recruitment status
-
Complete
+
Recruiting
Changes to
Data sharing plan
-
+
Not entered
Changes to
Date of first enrollment
-
2005
-
09
-07
04
:00:00
+
2019
-
02
-07
00
:00:00
Changes to
First name
-
Mercedes
+
María
Changes to
Midle name
-
+
de los Ángeles
Changes to
Health condition(s) or Problem(s) studied
-
Bronchial asthma
+
Asthma
Changes to
Last name
-
Ronquillo Diaz
+
Tamayo Gutierrez
Changes to
Medical Specialty
-
2nd
Degree Specialist in Allergology
+
1st
Degree Specialist in Allergology
Changes to
Target sample size
-
40
patients
(20 active, 20 placebo)
+
120
patients
Changes to
First Name
-
Raul
+
María
Changes to
Middle Name
-
Lazaro
+
de los Ángeles
Changes to
Last Name
-
Castro Almarales
+
Tamayo Gutierrez
Changes to
Specialty
-
2nd
degree specialist in Allergology
, Master in Transmmisible Deseases
+
1st
degree specialist in Allergology
Changes to
Affiliation
-
National Biopreparations Center (BIOCEN)
+
Calixto García Iñiguez
Changes to
Postal Address
-
Carretera
de
Beltran Km 1 1/2
+
Universidad y J , Plaza
de
la Revolucion
Changes to
City
-
Bejucal, Mayabeque
+
Havana
Changes to
Zip Code
-
13050, Box 6048
+
10400
Changes to
Telephone
-
+53-047066-82201 al 07, Allergen Department Ext.: 2100, 2101 and 2102.
+
78311508
Changes to
Telephone
-
+53-047066-82201 al 07,
Allergen Department
Ext.:
2100, 2101
and
2102
.
+
+53-047066-82201 al 07,
Ext.:
1145
and
1147
.
Changes to
Record Verification Date
-
2020/04/
15
+
2020/04/
30
Changes to
Next update date
-
2021/04/
15
+
2021/04/
30
Changes to
Secondary indentifying numbers
-
2005CALIXTOSL-BT06
+
GEC2017DPBT017
Revision of 30 April 2020 - 4:27pm:
Efficacy of VALERGEN-BT sublingual vaccine in asthmatic adults.
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:
Clinical trial of Blomia tropicalis (VALERGEN-BT) allergenic extract for sublingual therapeutic use in asthmatic adults sensitive to this allergen
Secondary indentifying numbers:
GEC2017DPBT017
Issuing authority of the secondary identifying numbers:
National Biopreparations Center (BIOCEN)
Primary sponsor:
National Biopreparations Center (BIOCEN)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Government funds
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 :
17/02/2017
Reference number:
1001/05-008-05B.
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
María
Midle name:
de los Ángeles
Last name:
Tamayo Gutierrez
Medical Specialty :
1st Degree Specialist in Allergology
Affiliation:
Calixto Garcia Inniguez Hospital
Postal address:
Universidad and J street
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-78311508
Email address:
mariatamayo@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, Joaquín Albarrán Hospital , MD Rosa Naranjo, 1st Degree Specialist in Allergology
Havana, 43 Clinic, MD Omar Herrera Barrios, 1st degree Allergology and 2nd Degree in Internal Medicine
Sancti Spíritus, Maternal and Child Surgical Clinical Hospital Camilo Cienfuegos, MD Niurka Martínez Díaz, 1st Degree Specialist in Allergology
Sancti Spíritus, University Polyclinic Juan M. Martínez Puentes (Pol. Norte), MD Álvaro González Iglesias,1st Degree Specialist in Allergology
Sancti Spíritus, University Polyclinic Antonio Ávila Valdivia, MD Ropsalig Guerra Marzo,1st Degree Specialist in Allergology
Sancti Spíritus, University Polyclinic Manuel de Jesús Lara Cantero,MD Adriana Albert Montero. 1st Degree Specialist in Allergology
Camagüey, Provincial Hospital Manuel Ascunce Domenech, MD Osaida Calderin Marin. 1st Degree Specialist in Allergology
Camagüey, Amalia Simoni Hospital, MD. Edilberto Machado del Risco. 1st Degree Specialist in Allergology
Research ethics committees:
Calixto Garcia Inniguez Hospital, June 22, 2004
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
07/02/2019
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):
(Active) study group: The study group was given increasing sublingual volumes (drops) of the researched vaccine at different doses (20, 200 and 2,000 BU/ml) for three weeks during the incremental phase. Afterwards, during the maintenance phase, a fixed dose was administered (20 drops of the 2,000 BU/ml dose, maximum permissible dose, 2,000 BU), until reaching twelve months, twice a week (Monday and Friday). Control group (placebo): The control group was given the placebo, namely, a diluent solution for allergenic extracts (BIOCEN). The placebo dosage was identical to that administered to the active group.
Intervention code:
Sublingual Immunotherapy
Allergens
Desensitization, Immunologic
Placebos
Intervention keyword:
allergenic extract Blomia tropicalis VALERGEN-BT
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):
Score by symptoms, score by drug consumption, respiratory function (value of Exhalation Peak Flow (EPF) and EPF Variability), cutaneous reactivity (Ch10 value: relative allergen concentration causing in the patient a bump similar to the one caused by a 10 mg/ml HCL histamine solution (54.3 mmol/l base histamine). Measuring time: 6 month and 1 year.
Key secondary outcomes:
Respiratory function classification (depends on EPF and Variability), general evaluation (depends on symptoms, medication, respiratory function, Ch10). Measuring time: 6 month and 1 year.
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 to Blomia tropicalis allergenic extract, 20,000 BU/ml VALERGEN-BT. The response to the allergen under study is predominant when compared to that obtained with other mites. 3. Patients included in the study will be patients clinically diagnosed as extrinsic asthmatics who, 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 16 and 45 years. 5. Any sex and race. 6. Patients expressing their consent in writing to participate in our trial.
Exclusion criteria:
1. Patients not giving their consent in writing to participate in our trial. 2. Patients on allergenic extract immunotherapy during the two preceding years. 3. Patients classified as intermittent or severe persistent asthmatics after being interviewed. 4. Patients with a diagnosed autoimmune disease of any kind. 5. Generalized severe eczema. 6. Patients with diagnosed tumoral disease. 7. Patients on betablocker treatment. 8. Patients with psychiatric disorders. 9. Patients not cooperating with treatment. 10. Patients who, at least one year before the study, needed immunostimulant or immunosuppressor treatment (no corticosteroids), including interferon and cyclosporine A. 11. Pregnancy and breastfeeding. 12. Adrenalin-contraindicated patients (high blood pressure). 13. Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules.
Type of population:
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:
Placebo
Study design:
Parallel
Phase:
2
Target sample size:
120 patients
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:
María
Middle Name:
de los Ángeles
Last Name:
Tamayo Gutierrez
Specialty:
1st degree specialist in Allergology
Affiliation:
Calixto García Iñiguez
Postal Address:
Universidad y J , Plaza de la Revolucion
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
78311508
Email :
mariatamayo@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:
2nd degree specialist in Allergology, Master in Transmmisible Deseases
Affiliation:
National Biopreparations Center (BIOCEN)
Postal Address:
Carretera de Beltran Km 1 1/2
City:
Bejucal, Mayabeque
Country:
Cuba
Zip Code:
13050, Box 6048
Telephone:
+53-047066-82201 al 07, Ext.:1145 and 1147.
Email :
rcastro@biocen.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
Not entered
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:
RPCEC00000029
Date of Registration in Primary Registry:
2010-12-08
Record Verification Date:
2020/04/30
Next update date:
2021/04/30
Link to the spanish version:
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