Revisions for Subcutaneous immunotherapy with PROLINEM-DS-Asthma- Adults-Fase II | Registro Público Cubano de Ensayos Clínicos

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Revision of 15 April 2020 - 5:19pm:

Subcutaneous immunotherapy with PROLINEM-DS-Asthma- Adults-Fase 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.

Scientific title:

Terapeutic effect and safety of therapeutic allergens vaccine Dermatophagoides siboney adjuvanted with proteoliposome of Neisseria meningitidis B in asthmatic patients sensitive to this mite.

Secondary indentifying numbers:

GEC2017PDS020

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:

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:

Mirta

Last name:

Alvarez Castello

Medical Specialty :

Second degree specialist in Allergology

Affiliation:

University Hospital General Calixto Garcia

Postal address:

Universidad y J , Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78311508

+53-78388296

Email address:

mirtaac@infomed.sld.cu

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:

Havana, Hermanos Ameijeiras Clinic Surgery Hospital, MD. Iglermys Figueroa Garcia. First degree specialist in Allergology

Research ethics committees:

General Calixto Garcia University Hospital, September 28, 2018

Hermanos Ameijeiras Clinic Surgery Hospital, September 20, 2018

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

23/07/2018

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):

Vaccination with PROLINEM DS (Dermatophagoides siboney allergen vaccine adjuvanted with Neisseria meningitidis proteoliposome) and Placebo by subcutaneous way: Group 1: Day 0: PROLINEM-DS 1,2 µg Der s1 (0,15 mL) Day 14: PROLINEM-DS 2 µg Der s1 (0,25 mL) Day 28: PROLINEM-DS 4 µg Der s1 (0,5 mL) Day 42: Placebo 0,5 mL Day 56: Placebo 0,5 mL 6 months of last shot: Placebo 0,5 mL Group 2: Day 0: PROLINEM-DS 1,2 µg Der s1 (0,15 mL) Day 14: PROLINEM-DS 2 µg Der s1 (0,25 mL) Day 28: PROLINEM-DS 4 µg Der s1 (0,5 mL) Day 42: PROLINEM-DS 4 µg Der s1 (0,5 mL) Day 56: PROLINEM-DS 4 µg Der s1 (0,5 mL) 6 months of last shot PROLINEM-DS 4 µg Der s1 (0,5 mL) Group 3: Day 0: Placebo 0,15 mL Day 14: Placebo 0,25 mL Day 28: Placebo 0,5 mL Day 42: Placebo 0,5 mL Day 56: Placebo 0,5 mL 6 months of last shot Placebo 0,5 mL

Intervention code:

Antigens, Dermatophagoides

Allergens

Neisseria meningitidis

Immunotherapy, Active

Desensitization, Immunologic

Placebos

Injections, Subcutaneous

Intervention keyword:

Prolinem 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):

1. Symptom score: Dyspnea, cough, expectoration, wheeze and tightness (four-digit score: 0 = non symptom, 1 = mild, 2 = moderate, 3 = severe). Measuring time: pre-treatment, and day 42, 3, 8 and 14 months. 2. Consumption of medications (three-digit score: 0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = corticosteroids). Measuring time: pre-treatment, and day 42, 3, 8 and 14 months.

Key secondary outcomes:

1. Expiratory lung function (spirometer forced technique with portable spirometer (DATOSPIR-70). Determine the Forced Vital Capacity (FVC), and Forced Expiratory Volume in one second (FEV1). Both are expressed as a percentage of the theoretical reference value calculated according to body weight of the patient). Measuring time: pre-treatment, 42 days, 3, 8, and 14 months. 2. 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: pre-treatment, 42 days, 3, 8, and 14 months. 3. Quality of life (Asthma Questionnaire Life Quality (Juniper)). Measuring time: Pretreatment and 3, 8, and 14 months. 4. Allergen-specific antibodies (antibody titer determination and IgG4 serum allergen-specific IgE in patients using an indirect ELISA). Measuring time: pre-treatment, 42 days, 3, 8, and 14 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, 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 star and stop of event);- Intensity of the AE (Light, Moderate, Severe); - Seriousness of the AE (Serious, No serious); - Attitude regarding the treatment in study (No changes, Dose modification, Temporary interruption, Definitive interruption of the treatment in study); - Result of the AE (Recovered, Improved, Persists, Sequels); - Causality Relationship (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated)). Measuring time: days 0, 14, 28, 42, 56, months 3, 5, 7, 8, 10, 12 and 14.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

50 years

Inclusion criteria:

1. Allergic asthmatic patients with a positive history of allergic symptoms caused by house dust. 2. Positive skin test to Dermatophagoides siboney with wheal diameter greater than or equal to 3 mm (VALERGEN-DS 20 000 BU / mL) and negative skin test Blomia tropicalis and Dermatophagoides pteronyssinus, or positive with a diameter lower than for DS. 3. Patients included in the study are patients diagnosed clinically as extrinsic asthmatics, which are classified as intermittent or persistent mild or moderate according to international guidelines for asthma (GINA, Global Initiative for Asthma) 4. Any color skin. 5. Patients express written consent to participate in the trial.

Exclusion criteria:

1. Patients previously treated with immunotherapy with allergenic extracts in previous five years. 2. Patients classified as severe intermittent and persistent asthmatics according to the guide International Asthma Initiative (GINA). 3. Diagnosed autoimmune disease of any kind. 4. Generalized severe eczema. 5. Patients with a diagnosis of tumor disease. 6. Patients under treatment with beta-blockers. 7. Patients where the use of adrenaline is contraindicated (arterial hypertension). 8. Pregnancy and lactation. 9. Patients who required treatment at least one year before the study immunostimulant or immunosuppressant (except corticosteroids), including interferons, cyclosporin A and natural immunomodulators (Vimang, Biomodulin, etc.). 10. Patients who have suffered from bacterial meningitis in the last year. 11. Patients with a history of psychiatric disorders. 12. Patients who do not wish to participate in the trial.

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:

60

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:

Second degree specialist in Allergology

Affiliation:

National Center of Bioproducts (BioCen), Group of Clinical Trials

Postal Address:

Carretera de Beltran Km 1 ½

City:

Bejucal, Mayabeque

Country:

Cuba

Zip Code:

ZC 13050, Box 6048

Telephone:

+53-047-06682201 up 07. Ext: 2100, 2101 and, 2102

Email :

rcastro@biocen.cu

inmunoterapia@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:

First degree specialist in Immunology

Affiliation:

National Center of Bioproducts (BioCen), Group of Clinical Trials

Postal Address:

Carretera de Beltran Km 1 ½

City:

Bejucal, Mayabeque

Country:

Cuba

Zip Code:

ZC 13050, Box 6048

Telephone:

+53-047-06682201 up 07. Ext: 2100, 2101 and, 2102

Email :

mcarmen.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:

RPCEC00000278

Date of Registration in Primary Registry:

14/06/2018

Record Verification Date:

2020/04/15

Next update date:

2021/04/15

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Subcutaneous immunotherapy with PROLINEM-DS-Asthma- Adults-Fase II

About the RPCEC

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