HUMAN EXPERIMENTATION. CODE OF ETHICS OF THE WORLD MEDICAL ASSOCIATION. DECLARATION OF HELSINKI.
P P RICKHAM
https://pubmed.ncbi.nlm.nih.gov/14150898Actively Recruiting
Phase 3
Age: 18Years - 60Years
All Genders
ID06916884
Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis
Led by Laboratorios Silanes S.A. de C.V. · Updated on 2025-04-08
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a fixed-dose combination of Desloratadine 5 mg and Betamethasone 0.25 mg compared to Desloratadine 5 mg alone for treating symptoms of allergic rhinitis. This Phase IIIb, multicenter, randomized, double-blind trial aims to understand how these treatments impact nasal symptoms in patients aged 18 to 60 with moderate to severe allergic rhinitis. Participants will receive either a tablet of the fixed-dose combination or Desloratadine alone once daily for 10 days. Nasal symptoms will be tracked daily using the Total Nasal Symptom Score (TNSS). Quality of life, global clinical impression, and patient global assessment will be measured at baseline, day 5, and day 10 visits. The study also monitors adverse events during the treatment period. Participants will complete daily symptom diaries at night and attend in-person visits at the start, day 5, and day 10 of treatment. Researchers will compare changes in nasal symptoms and quality of life scores between groups over the 10-day period. Safety will be assessed by analyzing any adverse events reported throughout the study. The total participation lasts for 10 days of treatment with follow-up assessments included.
CONDITIONS
Brief Title
Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Willing to participate in the study and able to provide written informed consent.
- Clinical diagnosis of active allergic rhinitis at study entry.
- Moderate to severe nasal symptoms with a Total Nasal Symptom Score (TNSS) of 5 or higher.
- Women of childbearing potential who are sexually active must use an acceptable contraceptive method.
- In the opinion of the investigator, the patient is indicated for treatment with the investigational product and may benefit clinically.
You will not qualify if you...
- 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 pregnancy during the study.
- Acute or chronic lower or upper respiratory tract infections such as cold, influenza, pneumonia, bronchitis, or chronic sinusitis.
- History of non-allergic rhinitis or related nasal conditions.
- History of nasal polyposis, primary ciliary dyskinesia syndrome, or non-allergic rhinitis with eosinophilia syndrome.
- Current smokers or history of alcohol/drug abuse in the past year.
- History of seizure disorders.
- History of severe chronic liver or kidney failure.
- Any condition affecting prognosis or outpatient management, as judged by the investigator.
- History of severe or unstable diseases that may interfere with study evaluations or pose risk.
- Oncology patients (except basal cell skin cancer) or serious illnesses with poor prognosis.
- Participation in another clinical trial or study within the past two weeks.
- Patients whose participation might be influenced, such as employees of the research center or sponsor.
- Symptoms or recent contact related to active COVID-19 infection within 14 days.
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 days
Participants take one tablet daily of either the fixed-dose combination of Desloratadine/Betamethasone or Desloratadine alone for 10 days. Nasal symptoms are recorded daily using a patient diary, and quality of life and clinical impressions are assessed during scheduled visits.
3 in-person visits (baseline, Day 5, and Day 10) plus daily diary entries
Trial Site Locations
Total: 1 location
1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Actively Recruiting
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Research Team
J
Jorge A Gonzalez, PhD
Y
Yulia Romero-Antonio, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Joan Busner, Steven D Targum
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https://pubmed.ncbi.nlm.nih.gov/35786822Effect of desloratadine versus placebo on nasal airflow and subjective measures of nasal obstruction in subjects with grass pollen-induced allergic rhinitis in an allergen-exposure unit.
Friedrich Horak, Ursula P Stübner, Rene Zieglmayer...
https://pubmed.ncbi.nlm.nih.gov/12063524Efficacy and safety of desloratadine in the treatment of perennial allergic rhinitis.
F Estelle R Simons, Bruce M Prenner, Albert Finn...
https://pubmed.ncbi.nlm.nih.gov/12642846Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis.
Teolinda Mendoza de Morales, Francis Sánchez
https://pubmed.ncbi.nlm.nih.gov/23282980Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial.
Gustavo F Wandalsen, Carolina Miranda, Luis Felipe Ensina...
https://pubmed.ncbi.nlm.nih.gov/27670203Desloratadine: an update of its efficacy in the management of allergic disorders.
David Murdoch, Karen L Goa, Susan J Keam
https://pubmed.ncbi.nlm.nih.gov/12962522A review of the efficacy of desloratadine, fexofenadine, and levocetirizine in the treatment of nasal congestion in patients with allergic rhinitis.
Claus Bachert
https://pubmed.ncbi.nlm.nih.gov/19539095