Status:
RECRUITING
Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 11 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06916884
Start Date
November 11 2024
End Date
June 11 2025
Last Update
April 8 2025
Active Locations (1)
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1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000