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

April 1, 2025 updated by: Laboratorios Silanes S.A. de C.V.

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nasal symptom changes will be assessed daily over a 10-day intervention period using the Total Nasal Symptom Score (TNSS) for allergic rhinitis. Patients will complete the first questionnaire during the randomization visit, followed by daily entries each night before bedtime using a patient diary. The final assessment will be completed during the study's end-of-treatment visit.

Quality of life, global clinical impression, and patient global assessment will be evaluated during in-person visits conducted at baseline, Day 5, and Day 10.

The incidence of adverse events throughout the study will be analyzed by treatment group and reported as frequencies and percentages. Events will be classified according to frequency, seriousness, severity, and their relationship to the investigational product.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Recruiting
        • Laboratorio Silanes, S.A. de C.V.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Murguía Martín, MD
        • Principal Investigator:
          • Tobías Avendaño Santiago, MD
        • Principal Investigator:
          • Erika N Durón López, MD
        • Principal Investigator:
          • María D Escobar Zalapa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Patients whose participation in the study may be influenced (e.g., employees of the research center or sponsor, incarcerated individuals, etc.).
  • Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough, dyspnea) and/or contact within the past 14 days with a suspected or confirmed COVID-19 case and/or a positive COVID-19 test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Desloratadine 5 mg + Betamethasone 0.25 mg
Administered orally, one tablet a day, for 10 days.
Drug: Desloratadine / Betamethasone in fixed dose
1 tablet, once a day of 5 mg / 0.25 mg
Other Names:
  • DESLORA / BETA
Active Comparator: Group B: Desloratadine 5 mg
Administered orally, one tablet a day, for 10 days.
Drug: Desloratadine
1 tablet, once a day of 5 mg
Other Names:
  • DESLORA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the magnitude of change in the TNSS over the 10-day intervention period versus the baseline, by treatment group.
Time Frame: 10 days

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.
Time Frame: 10 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 10 days
A Likert scale for quality of life is a rating scale used to measure opinions, attitudes, or behaviors. It consists of a statement or a question, followed by a series of six answer statements. Quality of life should be assessed by the principal investigator or designated physician at each visit.
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.
Time Frame: 10 days
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. The evaluation range goes from 1 - 7: 1- Marked improvement, 2- improvement, 3- slightly improved, 4- no change, 5- slightly worsened, 6- worsened, and 7- markedly worsened.
10 days
Describe the PGA of the treatment received at days 5 and 10 of the intervention, by treatment group.
Time Frame: 10 days
Patient's Global Assessment (PGA) is often assessed by a single question with a 0-4 response. On Days 5 and 10 of the intervention, a PGA of response to treatment will be conducted, using a scoring scale from 0 to 4, with 4 representing the worst possible assessment.
10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To report the percentage of therapeutic adherence at day 10 of the intervention in each treatment group.
Time Frame: 10 days
Therapeutic adherence will be defined by the principal researcher. Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: 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 Medica de Aguascalientes
  • Principal Investigator: María D Escobar Zalapa, MD, CICMEX Centro de Investigación Clínica de México S de RL de CV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

May 11, 2025

Study Completion (Estimated)

June 11, 2025

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Estimated)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30810-III-23(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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