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

Phase 3

Recruiting

• Conditions: Allergic Rhinitis
• Interventions: Drug: Desloratadine / Betamethasone in fixed dose; Drug: Desloratadine

• Registration Number: NCT06916884
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

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.

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 Timeline

• Study Start: 2024-11-11
• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-05-11
• Study Completion: 2025-06-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Desloratadine 5 mg + Betamethasone 0.25 mg	Desloratadine / Betamethasone in fixed dose	Administered orally, one tablet a day, for 10 days.
Group B: Desloratadine 5 mg	Desloratadine	Administered orally, one tablet a day, for 10 days.

Primary Outcome Measures

Name	Time	Method
Comparison of the magnitude of change in the TNSS over the 10-day intervention period versus the baseline, by treatment group.	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.
will be measured and compared between treatment groups.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laboratorio Silanes, S.A. de C.V.; 🇲🇽 Mexico City, Mexico