Revisions for Efficacy of nasal provocation test with VALERGEN-DP, DS and BT | Registro Público Cubano de Ensayos Clínicos

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Changes to Secondary indentifying numbers
-	GEC2017DPDSBT021	+	GEC2019DPDSBT023

Revision of 6 April 2022 - 4:08pm:

Efficacy of nasal provocation test with VALERGEN-DP, DS and BT

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:

Diagnostic efficacy of the nasal provocation test in patients with allergic rhinitis sensitive to house dust mites.

Secondary indentifying numbers:

GEC2019DPDSBT023

Issuing authority of the secondary identifying numbers:

National Center of Bioproducts (BioCen)

Source(s) of monetary or material support:

National Center for Biopreparations (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)

Authorization date :

06/06/2019

Reference number:

652/05.007.19BNV

Principal investigator

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

First name:

Omar

Last name:

Herrera Barrios

Medical Specialty :

Specialist in 1st grade Allergology and 2nd Degree in Internal Medicine

Affiliation:

43 Clinic, Alergology department

Postal address:

43 Avenue, corner 28. Reparto Kohly, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-78543212

Email address:

omar.herrera@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, Medical Surgical Research Center (CIMEQ), Jose Severino Rodriguez Canosa, MD. Specialist of 2nd degree in Allergology and, 1st Degree in Integral General Medicine.

Havana, University Hospital "General Calixto Garcia", Alina de la Caridad Gonzalez Paredes, MD. 1st Degree Specialist in Allergology and Integral General Medicine.

Research ethics committees:

Clinic of 43, January 4th, 2019

Medical Surgical Research Center (CIMEQ), September 13th, 2018

University Hospital "General Calixto García", February 4th, 2019

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

02/12/2019

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:

Allergic rhinitis

Health condition(s) code:

Rhinitis, Allergic

Rhinitis

Nose Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Immune System Diseases

Respiratory Hypersensitivity

Hypersensitivity, Immediate

Hypersensitivity

Intervention(s):

There are two groups of patients, one of the non-allergic patients and one of the allergic patients. Everyone will receive the two interventions. Control Group - Puncture Skin Test: It is performed on the both arms and, it will be do according to the requirements of the World Allergy Organization. Experimental Group - Nasal Provocation Test: Both groups will be do this test after the previous test, between one and eight weeks. The standardized allergenic extracts of DS, DP and BT, will be used to different elements (2, 20, 200, 2 000 and 20 000 UB / mL) with intervals of 15 minutes.

Intervention code:

Nasal Provocation Tests

Skin Tests

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):

Reactivity of the nasal mucosa (Score according to the Lebel scale). Measurement time: 15 minutes after Nasal Provocation Test

Key secondary outcomes:

1. Cutaneous reactivity (Average wheal diameter in mm). Measurement time: 15 minutes after Puncture Skin Test. 2. 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 Criteria: 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 the beginning and the end of the AE), Intensity of the AE (Light, Moderate, Severe), Seriousness of the AE (Serious, No serious) - Attitude regarding the procedure in study (Without changes, Dose modification, Temporary interruption, Definitive interruption), Result of the AE (Recovered, Improved, Persists, Sequels), Causal Relationship of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated)). Measurement time: after every test and, 72 hours.

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:

- Allergic group (Group A): 1) Patients with a positive clinical history of persistent allergic rhinitis to home dust, according to the diagnostic criteria. 2) Age between 18 and 50 years. 3) Patients with a skin prick test with allergen extracts investigated (VALERGEN-DP, VALERGEN-DS and VALERGEN-BT 20 000 UB/ mL), negative (diameter of wheal <3 mm). 4) People of any sex who express their informed consent in writing to participate in the study. 5) Negative nasal discharge. 6) Physical Examination of anterior nostril negative for allergic rhinitis. - Non-allergic group (Group B): 1) Non-allergic subjects without a positive clinical history of persistent allergic rhinitis to house dust, according to the diagnostic criteria described. 2) Age between 18 and 50 years. 3) Non-allergic individuals with a skin prick test with allergen extracts investigated (VALERGEN-DP, VALERGEN-DS and VALERGEN-BT at 20,000 UB/mL), negative (wheal diameter <3 mm). 4) People of any sex who express their informed consent in writing to participate in the study. 5) Negative nasal discharge. 6) Physical Examination of anterior nostril negative for allergic rhinitis.

Exclusion criteria:

1) Patients treated by Immunotherapy with allergenic extracts of D. pteronyssinus, D. siboney, D. farinae, B. tropical or home dust in the last two years. 2) Patients with symptoms of asthma, otitis media with effusion, acute sinusitis, rhinitis or conjunctivitis at the time of the tests. 3) Current use of drugs that interfere with the cutaneous and nasal reaction of the tests to be performed, which must be previously suspended. 4) Dermographism, atopic dermatitis in the area of skin test and urticaria. 5) Patients who do not express their written consent to participate in the study.

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:

Diagnostic

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

300

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:

Medical Specialist of Second Degree of General Integral Medicine and Allergology

Affiliation:

National Center for Biopreparations (BioCen), Clinical Trials Group

Postal Address:

Carretera de Beltran km 1 1/2, Bejucal

City:

Mayabeque

Country:

Cuba

Zip Code:

32600

Telephone:

+53-47682441

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:

Raul

Middle Name:

Lazaro

Last Name:

Castro Almarales

Specialty:

Medical Specialist of Second Degree of General Integral Medicine and Allergology

Affiliation:

National Center of Bioproducts (BioCen)

Postal Address:

Carretera de Beltran km 1 1/2, Bejucal

City:

Mayabeque

Country:

Cuba

Zip Code:

32600

Telephone:

+53-47682441

Email :

rcastro@biocen.cu

inmunoterapia@infomed.sld.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:

RPCEC00000301

Date of Registration in Primary Registry:

15/04/2019

Record Verification Date:

2020/04/15

Next update date:

2021/04/15

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Efficacy of nasal provocation test with VALERGEN-DP, DS and BT

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