Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine

NCT06916884 | Recruiting Phase 3

• 1 other identifier: SIL-30810-III-23(1)
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Phase IIIb , longitudinal, multicenter, randomized, double-blind, to evaluate efficacy and safety of the fixed-dose combination of Desloratadine 5 mg / Betamethasone 0.25 mg versus Desloratadine 5 mg monotherapy as treatment for symptoms associated with allergic rhinitis.

Conditions

Allergic Rhinitis

Keywords

rhinitis; allergies; respiratory system

Outcome Measures

Primary Outcomes (2)

• Comparison of the magnitude of change in the TNSS over the 10-day intervention period versus the baseline, by treatment group.

  The Total Nasal Symptom Score (TNSS) is a clinical measure used to assess the severity of nasal symptoms in patients, particularly those suffering from allergic rhinitis. It assess the four cardinal symptoms of allergic rhinitis: sneezing, rhinorrhea (nasal mucus discharge), nasal pruritus (itching), and nasal obstruction (difficulty breathing). According to the evaluation the magnitude of the symptoms could be classified as: None, Mild, Moderate and Severe. The researcher will apply the TNSS score to each patient at each visit and follow up call, to assess improvement in symptoms. At the end of the clinical trial the magnitude of change will be measured and compared between treatment groups.

  10 days

• will be measured and compared between treatment groups.

  To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher.

  10 days

Secondary Outcomes (3)

• Compare quality of life, measured as the change in score on the modified Likert scale for this outcome, by treatment group, at days 5 and 10 of the intervention compared to baseline.

  10 days

• Describe disease severity and improvement using the CGI scale by treatment group, at days 5 and 10 of the intervention compared to baseline.

  10 days

• Describe the PGA of the treatment received at days 5 and 10 of the intervention, by treatment group.

  10 days

Other Outcomes (1)

• To report the percentage of therapeutic adherence at day 10 of the intervention in each treatment group.

  10 days

Study Arms (2)

Group A: Desloratadine 5 mg + Betamethasone 0.25 mg

EXPERIMENTAL

Administered orally, one tablet a day, for 10 days.

Drug: Desloratadine / Betamethasone in fixed dose

Group B: Desloratadine 5 mg

ACTIVE COMPARATOR

Administered orally, one tablet a day, for 10 days.

Drug: Desloratadine

Interventions

Desloratadine / Betamethasone in fixed dose DRUG

1 tablet, once a day of 5 mg / 0.25 mg

Also known as: DESLORA / BETA

Group A: Desloratadine 5 mg + Betamethasone 0.25 mg

Desloratadine DRUG

1 tablet, once a day of 5 mg

Also known as: DESLORA

Group B: Desloratadine 5 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to participate in the study and able to provide written informed consent.
• Clinical diagnosis (based on medical history and physical examination) of active allergic rhinitis at study entry.
• Patients presenting with moderate to severe nasal symptoms, with a Total Nasal Symptom Score (TNSS) ≥5.
• In the case of women of childbearing potential who are sexually active, the use of an acceptable contraceptive method (barrier and/or hormonal), as determined by the investigator.
• In the opinion of the Principal Investigator or treating physician, the patient is indicated for treatment with the investigational product and may derive clinical benefit from it.

You may not qualify if:

• Patients for whom the investigational drug is medically contraindicated.
• Known allergy or hypersensitivity to the active ingredient, study medications, related products, or excipients.
• History of nasal trauma (surgical or accidental) within the past week.
• Positive pregnancy test, pregnant or breastfeeding women, or women planning to become pregnant during the course of the study.
• Acute or chronic lower or upper respiratory tract infections, such as the common cold, influenza, pneumonia, bronchitis, or chronic sinusitis.
• History of non-allergic rhinitis, such as chronic non-allergic rhinitis, drug-induced rhinitis, atrophic rhinitis, hormonal rhinitis, or unilateral rhinitis, as reported in the medical history or patient interview.
• History of nasal polyposis, primary ciliary dyskinesia syndrome, and/or non-allergic rhinitis with eosinophilia syndrome (NARES).
• Current smokers, or history of alcohol and/or drug abuse in the past year according to DSM-V criteria.
• History of seizure disorders, status epilepticus, or generalized tonic-clonic seizures.
• History of chronic hepatic failure classified as Child-Pugh C, as reported in the medical history or patient interview.
• History of chronic renal failure (glomerular filtration rate \< 30 mL/min/1.73 m²), as reported in the medical history or patient interview.
• Any condition, in the investigator's opinion, that affects prognosis or precludes outpatient management, which must be evaluated by the principal investigator to determine the subject's eligibility.
• History of severe, progressive, unstable, or advanced disease of any kind that could interfere with efficacy and safety evaluations or pose a risk to the patient.
• Oncology patients (except those with basal cell skin cancer) or patients with serious illnesses who, in the investigator's opinion, have a poor prognosis or life expectancy of less than one year, including those with mental health disorders.
• Active participation in another clinical trial involving an investigational treatment or participation in any clinical study within the previous two weeks.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

RECRUITING

Related Publications (16)

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  PMID: 12063524 BACKGROUND

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MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis; Hypersensitivity

Interventions

desloratadine; Betamethasone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Francisco Murguía Martín, MD

  Unidad de Medicina Especializada SMA

  PRINCIPAL INVESTIGATOR

• Tobías Avendaño Santiago, MD

  Oaxaca Site Management Organization, S.C

  PRINCIPAL INVESTIGATOR

• Erika N Durón López, MD

  Centro de Investigación Médica de Aguascalientes

  PRINCIPAL INVESTIGATOR

• María D Escobar Zalapa, MD

  CICMEX Centro de Investigación Clínica de México S de RL de CV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge A Gonzalez, PhD

CONTACT

5254883785; jogonzalez@silanes.com.mx

Yulia Romero-Antonio, B.S.

CONTACT

5254883785; yromero@silanes.com.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: November 11, 2024
• Primary Completion: May 11, 2025
• Study Completion: June 11, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)