biomodulina T phase II study in geriatric patients with respiratory diseases

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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:

Phase II Clinical Study Immunomodulating Effect of Biomodulina T in geriatric patients with frequent respiratory diseases.

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

National Center of Bioproducts (BioCen) Cuban 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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Barbara

Midle name:

Mayra

Last name:

Leyva Salermo

Medical Specialty :

Second Degree Specialist in Geriatrics

Affiliation:

Longevity Research Center, Aging and Health. CITED

Postal address:

27th Street and G Vedado, Revolution Square

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382174

Email address:

babyl@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:

CITED November 3, 2014

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

30/04/2015

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:

Recurrent respiratory diseases

Intervention(s):

Group I (Experimental): 3 mg daily Biomodulina T be administered sublingually (divided by 2 times daily) for 25 days Group II (Control): 3 mg daily Biomodulina T be administered intramuscularly (1 time per day) for 25 days

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):

Immunologic: Subpopulations CD3, CD4, CD8 and CD19 (by flow cytometry). Measurement time: every 2 months after the first administration and up to 6 months after treatment.

Key secondary outcomes:

- Clinics Influenza (yes/no). Measurement time: every 2 months after the first administration and up to 6 months after treatment. Bronchopneumonia (yes/no). Measurement time: every 2 months after the first administration and up to 6 months after treatment. Number of Income (yes/no, if yes, how many in one year). Measurement time: every 2 months after the first administration and up to 6 months after treatment. - Adverse events (AEs). Measurement time: every 2 months after the first administration and up to 6 months after treatment. It is measured as follows: Occurrence of an EA in the patient (yes / no). Description EA (Name of adverse event). According to the preliminary information available (unexpected and expected) According to the intensity of EA (Mild, Moderate) Severity EA (Grave / serious, not serious / not serious) Attitude regarding the treatment under study (unchanged, temporary interruption or definitive treatment under study) Outcome of EA (recovered, improved persists or sequels) Causality relationship (1. Very Likely, 2.Probable, 3.Posible, 4.Improbable, 5.No related, 6.No evaluable)

Selection criterias

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

Gender:

Male/Female

Minimum age:

60 years

Maximum age:

None

Inclusion criteria:

1. Background of viral infections and / or recurrent bacterial (more than 2) during the last twelve months. 2. Reduction of some parameters of Cellular Immunity (populations of T and B lymphocytes, subpopulations CD4, CD8 or cytokines, and / or populations of immune complexes). 3. Altered skin tests. 4. People over 60 years of age, of both sexes regardless of skin color. 5. Willingness to participate in the trial.

Exclusion criteria:

1. Patients with collagen diseases. 2. Liver chronic carriers. 3. Carriers Tuberculosis and Hansen. 4. Carriers of diagnosed malignancies. 5. Patients who have previously received some form of treatment effects on the immune system, whether modulators or suppressors in the previous six months. 6. Patients in convalescence period (up to two weeks) of an acute infectious disease that could alter the immune response. 7. Patients with diseases that alter gastrointestinal drug absorption.

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:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

50

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:

Barbara

Middle Name:

Mayra

Last Name:

Leyva Salermo

Specialty:

Second Degree Specialist in Geriatrics

Affiliation:

Longevity Research Center, Aging and Health. CITED

Postal Address:

27th Street and G Vedado, Revolution Square

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+537-838-2174

Email :

babyl@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:

Elisa

Middle Name:

Maria

Last Name:

Aznar García

Specialty:

PhD Health. Titular Researcher. Drug Registration Specialist and Clinical Trials.

Affiliation:

National Center of Bioproducts (BioCen)

Postal Address:

Beltran Road, Km 1 ½ Bejucal.

City:

Mayabeque

País:

Cuba

Zip Code:

32600

Telephone:

+5347 682201 ext.1145

Email :

eaznar@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:

RPCEC00000194

Date of Registration in Primary Registry:

13/04/2015

Record Verification Date:

2015/04/13

Next update date:

2016/04/13

Link to the spanish version:

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biomodulina T phase II study in geriatric patients with respiratory diseases

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