Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
Recruiting
Phase 3Interventional Study
Allergic Rhinitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Laboratorios Silanes S.A. de C.V. · Industry
Who this trial is looking for
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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.
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Eligibility Criteria
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 Nas…
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.
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