Last updated 16 days ago
Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
70 patients around the world
Available in Mexico
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.
Laboratorios Silanes S.A. de C.V.
1Research sites
70Patients around the world
This study is for people with
Allergic rhinitis
Requirements for the patient
To 60 Years
All Gender
Medical requirements
- Willing to participate in the study and able to provide written informed consent.Clinical diagnosis 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, 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.
- 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 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, 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.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, as reported in the medical history or patient interview.Any condition, in the investigator's opinion, that affects prognosis or precludes outpatient management.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 or patients with serious illnesses who have a poor prognosis or life expectancy of less than one year.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.Patients with symptoms suggestive of active COVID-19 infection and/or contact within the past 14 days with a suspected or confirmed COVID-19 case.
Sites
Laboratorios Silanes S.A.
Recruiting
StudyDESCUBRA
SponsorLaboratorios Silanes S.A. de C.V.
Study typeInterventional
Conditions
Requirements
To 60 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06916884
