BridgeMD
Compares treatment options for Allergic Rhinitis
Official title Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
ClinicalTrials.gov ID: NCT06916884
What this study is testing
What is Desloratadine / Betamethasone in fixed dose?
Desloratadine / Betamethasone in fixed dose is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for allergic rhinitis.
Also referred to as DESLORA / BETA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- In the opinion of the Principal Investigator or treating physician, the patient is indicated for treatment with the investigational product and may...
You likely can't join if
- 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...
See the full eligibility 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.
- 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 how well it works 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.