Can an antihistamine–steroid combo pill beat standard allergy meds?
NCT ID NCT06916884
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a once-daily pill combining desloratadine (an antihistamine) and betamethasone (a corticosteroid) relieves nasal allergy symptoms better than desloratadine alone. About 70 adults with moderate-to-severe allergic rhinitis will take either the combo or the single drug for 10 days. Researchers will compare changes in nasal symptom scores and track side effects to see if the combination offers a meaningful advantage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a fixed-dose combination of desloratadine (an antihistamine) and betamethasone (a corticosteroid)
- What this could lead to
- If the combination works better than the antihistamine alone, it could offer a more effective daily pill for people with moderate-to-severe allergic rhinitis.
- What could go wrong
- This is a relatively small phase 3 trial (70 people), and adding a steroid may increase side effects without providing meaningful extra relief. Results may not apply to all allergy sufferers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
70 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
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Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Laboratorio Silanes, S.A. de C.V.
Mexico City, 11000, Mexico
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