Efficacy of VALERGEN-DS subcutaneous vaccine in asthmatic adults.

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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:

Clinical trial of Dermatophagoides siboney (VALERGEN-DS) allergenic extract for therapeutic use in asthmatic adults sensitive to this allergen

Secondary indentifying numbers:

2003CALIXTOSC- DS02

Issuing authority of the secondary identifying numbers:

National Biopreparations Center (BIOCEN)

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 :

06/02/2003

Reference number:

044/40-261

Principal investigator

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

First name:

Mercedes

Last name:

Ronquillo Diaz

Medical Specialty :

2nd 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:

alergia@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:

Calixto Garcia Inniguez Hospital, May 22, 2002

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

16/03/2003

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:

Bronchial 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 subcutaneous injections in deltoid region, and increasing volumes of the researched vaccine at different doses (20, 200, 2,000 and 20,000 BU/ml) for 13 weeks during the incremental phase. Afterwards, during the maintenance phase, a fixed dose was administered (0.3ml (6,000BU) of the 20,000BU/ml dose, maximum permissible dose, 6,000BU), until reaching 12 months every 4 weeks. 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:

Pyroglyphidae

Desensitization, Immunologic

Allergens

Injections, Subcutaneous

Placebos

Intervention keyword:

allergenic extract Dermatophagoides siboney VALERGEN-DS

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 D. siboney allergenic extract, 20,000BU/ml VALERGEN-DS. 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:

3

Target sample size:

40 patients (20 active, 20 placebo)

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:

Raul

Middle Name:

Lazaro

Last Name:

Castro Almarales

Specialty:

2nd degree specialist in Allergology, Master in Transmmisible Deseases

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Department

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, Allergen Department Ext.: 2100, 2101 y 2102.

Email :

rcastro@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:

Raul

Middle Name:

Lazaro

Last Name:

Castro Almarales

Specialty:

2nd degree specialist in Allergology, Master in Transmmisible Deseases

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Department

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, Allergen Department 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:

RPCEC00000028

Date of Registration in Primary Registry:

2010-12-07

Record Verification Date:

2008-01-22 19:00

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Efficacy of VALERGEN-DS subcutaneous vaccine in asthmatic adults.

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