Revisions for Intranasal chlorpheniramine (0.4%) for the perennial allergic rhinitis (AR) treatment in adults. Phase IV. | Registro Público Cubano de Ensayos Clínicos

--- 13 February 2025 - 4:41pm by Ferrer
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-Dr. Ferrer BioPharma
+APEX DRUG HOUSE
-Dr. Ferrer BioPharma
+APEX DRUG HOUSE
-Dr. Ferrer BioPharma, Cuban Ministry of Public Health (MINSAP)
+APEX DRUG HOUSE, Cuban Ministry of Public Health (MINSAP)

Revision of 13 February 2025 - 4:41pm:

Intranasal chlorpheniramine (0.4%) for the perennial allergic rhinitis (AR) treatment in adults. Phase IV.

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:

Multicenter phase IV clinical study in two stages, to evaluate the efficacy, safety and use in real clinical practice of Chlorpheniramine Maleate (0.4%) nasal spray, in patients with perennial allergic rhinitis.

Acronym of Scientific Title:

Not applicable

Secondary indentifying numbers:

DFB-004

Issuing authority of the secondary identifying numbers:

APEX DRUG HOUSE

Source(s) of monetary or material support:

APEX DRUG HOUSE, 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:

Trials notification

Regulatory instance:

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

Notification date :

05/02/2025

Reference number:

In process

Principal investigator

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

First name:

Iglermys

Last name:

Figueroa Garcia

Medical Specialty :

Second Degree Specialist in Allergology and Second Degree Specialist in Comprehensive General Medicine

Affiliation:

“Hermanos Ameijeiras” Surgical Clinical Hospital

Postal address:

San Lazaro # 701 esq. to Belascoain.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-54004305

Email address:

iglermis@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, “Calixto Garcia” University Hospital , Dignalvis Aldana Patterson, MD. Second Degree Specialist in Allergology

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

12/02/2025

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:

Perennial Allergic Rhinitis

Intervention(s):

Stage I Chlorpheniramine group (experimental): Chlorpheniramine maleate (0.4%), 2 sprays in each nostril, 4 times a day, for 28 days. Placebo group (control): Placebo: 2 sprays in each nostril, 4 times a day, for 28 days. Stage II Chlorpheniramine group (experimental): Chlorpheniramine maleate (0.4%), 2 sprays in each nostril, 4 times a day, for 6 months.

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):

Total nasal symptoms (It is evaluated using the Total Nasal Symptoms Questionnaire (TNSS)). Measurement time: Stage I: At baseline and, 7, 14 and, 28 days after treatment started. Stage II: At baseline, 7, 14 and, 28 days and, 3 and 6 months after treatment started.

Key secondary outcomes:

1. Quality of life (It is evaluated according to the score for each of the items and the total score of the following questionnaires: Sino-nasal Symptoms Questionnaire (SNOT-22), Leicester Cough Questionnaire (LCQ), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)).Measurement time: Stage I: At baseline and, 7, 14 and, 28 days after treatment started. Stage II: At baseline, 7, 14 and, 28 days and, 3 and 6 months after treatment started. 2. Adverse Events-AE (Occurrence of any AE in the subject (yes/no), Description of the AE (Name of the adverse event), Duration of the EA (Difference in dates between the start and end of the event), AE intensity (Mild, Moderate, Severe), Severity of the AE (Serious/serious, Not serious/not serious), Attitude towards the study treatment (no changes, dose modification, temporary or permanent interruption of the study treatment), Result of the AE (recovered, improved, persists or sequelae), Causality relationship (1. Very Likely, 2. Probable, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluable)). Measurement time: Stage I: At baseline and, 7, 14 and, 28 days after treatment started. Stage II: At baseline, 7, 14 and, 28 days and, 3 and 6 months after treatment started.

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

- Age and Gender: 1. Male and female patients over 18 years of age. Diagnosis of Perennial Allergic Rhinitis (PRA): 1. Documented history of RAP for at least 1 year. 2. Confirmation of IgE-mediated hypersensitivity to perennial allergens (for example, dust mites, mold, cat or dog dander), demonstrated by: a)Skin prick test: Wheal with a diameter ≥5 mm larger than the negative control, with a positive histamine control (>5 mm). b) Measurement of specific IgE in serum. - Ability to Participate: 1. Willingness and ability to comply with the protocol requirements and attend scheduled visits. - Health Status: 1. Good general health, with no significant medical conditions that interfere with the interpretation of the results. - - - Consent: 1. Ability to provide written informed consent. cheduled visits.

Exclusion criteria:

- Nasal Conditions: 1. Superficial erosion or ulceration of the nasal mucosa. 2. Clinically significant nasal polyposis or severe structural abnormalities. 3. Chronic recurrent sinusitis (>3 episodes per year). - Respiratory Diseases: 1. Active or recent respiratory infections (<14 days). 2. Severe lung diseases (COPD, moderate/severe asthma requiring more than rescue bronchodilators). - Use of Conflicting Medications: 1. Recent use of medications that may interfere with the evaluation of symptoms (antihistamines, decongestants, corticosteroids). 2. Therapy with monoamine oxidase inhibitors (MAOIs). 3. Active immunotherapy or recent changes in immunotherapy doses. - Cardiac or Neurological Conditions: 1. Clinically significant cardiac arrhythmias or QT interval prolongation (>500 ms). 2. Clinically diagnosed obstructive sleep apnea syndrome. - Other Exclusions: 1. Known hypersensitivity to chlorpheniramine maleate or its components. 2. Nasal or sinus surgery in the last year. 3. Pregnancy or breastfeeding. 4. Inability to give informed consent or comply with the protocol.

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:

4

Target sample size:

400

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:

Iglermys

Last Name:

Figueroa Garcia

Specialty:

Second Degree Specialist in Allergology and Second Degree Specialist in Comprehensive General Medicine

Affiliation:

“Hermanos Ameijeiras” Surgical Clinical Hospital

Postal Address:

San Lazaro # 701 esq. to Belascoain

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-54004305

Email :

iglermis@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:

Cesar

Middle Name:

Ulices

Last Name:

Alas Pineda

Specialty:

Medicine and General Surgery

Affiliation:

Analytic department, Biopharma Pulmonary Institute

Postal Address:

701 N Federal Hwy, Suite 501

City:

Hallandale Beach, Florida

Country:

United States

Zip Code:

33009

Telephone:

+1 (603) 349 0506

Email :

analytics@pulmonary-institute.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

“Hermanos Ameijeiras” Surgical Clinical Hospital

“Calixto Garcia” University Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

28/01/2025

22/01/2025

Postal address of Ethic Committee :

San Lazaro # 701 esq. a Belascoain, Centro Habana, ZC:10400, Havana, Cuba

Avenida Universidad y J. Vedado. ZC: 10400, Plaza, Havana, Cuba

Telephone:

+53-52833178

+53-52709138

Email:

hha@infomed.sld.cu

lydm87@gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

27/01/2026

Date of available results:

02/03/2026

Date of first publication:

02/05/2026

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:

RPCEC00000454

Date of Registration in Primary Registry:

12/02/2025

Record Verification Date:

2025/02/13

Next update date:

2026/02/13

Link to the spanish version:

Click here

Registered Trials

Registration process

Intranasal chlorpheniramine (0.4%) for the perennial allergic rhinitis (AR) treatment in adults. Phase IV.

About the RPCEC

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