Allergic RhinitisPhase 3DESCUBRANCT06916884
Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
A Phase 3 study testing Desloratadine / Betamethasone in fixed dose and Desloratadine in people with Allergic Rhinitis, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Desloratadine / Betamethasone in fixed dose and Desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- 11 Nov 2024to 15 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis
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.
Read the detailed description
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.
- Conditions
- Allergic Rhinitis
- Being tested
- Desloratadine / Betamethasone in fixed dose, Desloratadine
- Keywords
- rhinitis, allergies, respiratory system
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine / Betamethasone in fixed doseDrug
Also called DESLORA / BETA
1 tablet, once a day of 5 mg / 0.25 mg
DesloratadineDrug
Also called DESLORA
1 tablet, once a day of 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A: Desloratadine 5 mg + Betamethasone 0.25 mg | Experimental | Administered orally, one tablet a day, for 10 days. Receives: Drug: Desloratadine / Betamethasone in fixed dose |
| Group B: Desloratadine 5 mg | Active comparator | Administered orally, one tablet a day, for 10 days. Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the magnitude of change in the TNSS over the 10-day intervention period versus the baseline, by treatment group.
The Total Nasal Symptom Score (TNSS) is a clinical measure used to assess the severity of nasal symptoms in patients, particularly those suffering from allergic rhinitis. It assess the four cardinal symptoms of allergic rhinitis: sneezing, rhinorrhea (nasal mucus discharge), nasal pruritus (itching), and nasal obstruction (difficulty breathing). According to the evaluation the magnitude of the symptoms could be classified as: None, Mild, Moderate and Severe.
The researcher will apply the TNSS score to each patient at each visit and follow up call, to assess improvement in symptoms. At the end of the clinical trial the magnitude of change will be measured and compared between treatment groups.
Measured: 10 days
Adverse events will be measured and compared between treatment groups.
To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher.
Measured: 10 days
Secondary outcomes (3)
Compare quality of life, measured as the change in score on the modified Likert scale for this outcome, by treatment group, at days 5 and 10 of the intervention compared to baseline.
A Likert scale for quality of life is a rating scale used to measure opinions, attitudes, or behaviors. It consists of a statement or a question, followed by a series of six answer statements. Quality of life should be assessed by the principal investigator or designated physician at each visit.
Measured: 10 days
Describe disease severity and improvement using the CGI scale by treatment group, at days 5 and 10 of the intervention compared to baseline.
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. The evaluation range goes from 1 - 7: 1- Marked improvement, 2- improvement, 3- slightly improved, 4- no change, 5- slightly worsened, 6- worsened, and 7- markedly worsened.
Measured: 10 days
Describe the PGA of the treatment received at days 5 and 10 of the intervention, by treatment group.
Patient's Global Assessment (PGA) is often assessed by a single question with a 0-4 response. On Days 5 and 10 of the intervention, a PGA of response to treatment will be conducted, using a scoring scale from 0 to 4, with 4 representing the worst possible assessment.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start11 Nov 2024
- Primary completion15 Oct 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Murguía Martín, MD, Principal investigator, Unidad de Medicina Especializada SMATobías Avendaño Santiago, MD, Principal investigator, Oaxaca Site Management Organization, S.CErika N Durón López, MD, Principal investigator, Centro de Investigación Médica de AguascalientesMaría D Escobar Zalapa, MD, Principal investigator, CICMEX Centro de Investigación Clínica de México S de RL de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916884
- Sponsor's protocol ID
- SIL-30810-III-23(1)
- Acronym
- DESCUBRA
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
RICKHAM PP. HUMAN EXPERIMENTATION. CODE OF ETHICS OF THE WORLD MEDICAL ASSOCIATION. DECLARATION OF HELSINKI. Br Med J. 1964 Jul 18;2(5402):177. doi: 10.1136/bmj.2.5402.177. No abstract available.
PubMed 14150898Shukla AK, Jhaj R, Misra S, Ahmed SN, Nanda M, Chaudhary D. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. J Family Med Prim Care. 2021 Sep;10(9):3303-3308. doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.
PubMed 34760748Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PubMed 20526405Comite Nacional de Endocrinologia. [Considerations for safe glucocorticoid therapy]. Arch Argent Pediatr. 2018 Jun 1;116(3):s71-s76. doi: 10.5546/aap.2018.s71. Spanish.
PubMed 35786822Horak F, Stubner UP, Zieglmayer R, Harris AG. Effect 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. J Allergy Clin Immunol. 2002 Jun;109(6):956-61. doi: 10.1067/mai.2002.124657.
PubMed 12063524Simons FE, Prenner BM, Finn A Jr; Desloratadine Study Group. Efficacy and safety of desloratadine in the treatment of perennial allergic rhinitis. J Allergy Clin Immunol. 2003 Mar;111(3):617-22. doi: 10.1067/mai.2003.168.
PubMed 12642846Mendoza de Morales T, Sanchez F. Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis. World Allergy Organ J. 2009 Apr;2(4):49-53. doi: 10.1097/WOX.0b013e31819f2105.
PubMed 23282980Wandalsen GF, Miranda C, Ensina LF, Sano F, Amazonas RB, Silva JMD, Sole D. Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial. Braz J Otorhinolaryngol. 2017 Nov-Dec;83(6):633-639. doi: 10.1016/j.bjorl.2016.08.009. Epub 2016 Sep 13.
PubMed 27670203Murdoch D, Goa KL, Keam SJ. Desloratadine: an update of its efficacy in the management of allergic disorders. Drugs. 2003;63(19):2051-77. doi: 10.2165/00003495-200363190-00010.
PubMed 12962522Bachert C. A review of the efficacy of desloratadine, fexofenadine, and levocetirizine in the treatment of nasal congestion in patients with allergic rhinitis. Clin Ther. 2009 May;31(5):921-44. doi: 10.1016/j.clinthera.2009.05.017.
PubMed 19539095Snyman JR, Potter PC, Groenewald M, Levin J; Claricort Study Group. Effect of betamethasone-loratadine combination therapy on severe exacerbations of allergic rhinitis : a randomised, controlled trial. Clin Drug Investig. 2004;24(5):265-74. doi: 10.2165/00044011-200424050-00003.
PubMed 17503888Bernstein DI, Schwartz G, Bernstein JA. Allergic Rhinitis: Mechanisms and Treatment. Immunol Allergy Clin North Am. 2016 May;36(2):261-78. doi: 10.1016/j.iac.2015.12.004. Epub 2016 Mar 10.
PubMed 27083101May JR, Dolen WK. Management of Allergic Rhinitis: A Review for the Community Pharmacist. Clin Ther. 2017 Dec;39(12):2410-2419. doi: 10.1016/j.clinthera.2017.10.006. Epub 2017 Oct 25.
PubMed 29079387Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.
PubMed 27434218Greiner AN, Hellings PW, Rotiroti G, Scadding GK. Allergic rhinitis. Lancet. 2011 Dec 17;378(9809):2112-22. doi: 10.1016/S0140-6736(11)60130-X. Epub 2011 Jul 23.
PubMed 21783242
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06916884
- Acronym / sponsor ID
- DESCUBRA / SIL-30810-III-23(1)
- Conditions
- Allergic Rhinitis
- Keywords
- rhinitis, allergies, respiratory system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Desloratadine 5 mg + Betamethasone 0.25 mg | Experimental | Drug: Desloratadine / Betamethasone in fixed doseAdministered orally, one tablet a day, for 10 days. |
| Group B: Desloratadine 5 mg | Active comparator | Drug: DesloratadineAdministered orally, one tablet a day, for 10 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desloratadine / Betamethasone in fixed doseAlso: DESLORA / BETA1 tablet, once a day of 5 mg / 0.25 mg | Drug | Group A: Desloratadine 5 mg + Betamethasone 0.25 mg |
| DesloratadineAlso: DESLORA1 tablet, once a day of 5 mg | Drug | Group B: Desloratadine 5 mg |
Primary outcome
Comparison of the magnitude of change in the TNSS over the 10-day intervention period versus the baseline, by treatment group.
Time frame: 10 days
The Total Nasal Symptom Score (TNSS) is a clinical measure used to assess the severity of nasal symptoms in patients, particularly those suffering from allergic rhinitis. It assess the four cardinal symptoms of allergic rhinitis: sneezing, rhinorrhea (nasal mucus discharge), nasal pruritus (itching), and nasal obstruction (difficulty breathing). According to the evaluation the magnitude of the symptoms could be classified as: None, Mild, Moderate and Severe. The researcher will apply the TNSS score to each patient at each visit and follow up call, to assess improvement in symptoms. At the end of the clinical trial the magnitude of change will be measured and compared between treatment groups.
Adverse events will be measured and compared between treatment groups.
Time frame: 10 days
To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher.
3 secondary outcomes
Compare quality of life, measured as the change in score on the modified Likert scale for this outcome, by treatment group, at days 5 and 10 of the intervention compared to baseline.
Time frame: 10 days
Describe disease severity and improvement using the CGI scale by treatment group, at days 5 and 10 of the intervention compared to baseline.
Time frame: 10 days
Describe the PGA of the treatment received at days 5 and 10 of the intervention, by treatment group.
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 14150898RICKHAM PP. HUMAN EXPERIMENTATION. CODE OF ETHICS OF THE WORLD MEDICAL ASSOCIATION. DECLARATION OF HELSINKI. Br Med J. 1964 Jul 18;2(5402):177. doi: 10.1136/bmj.2.5402.177. No abstract available.
- Background: PubMed 34760748Shukla AK, Jhaj R, Misra S, Ahmed SN, Nanda M, Chaudhary D. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. J Family Med Prim Care. 2021 Sep;10(9):3303-3308. doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.
- Background: PubMed 20526405Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Background: PubMed 35786822Comite Nacional de Endocrinologia. [Considerations for safe glucocorticoid therapy]. Arch Argent Pediatr. 2018 Jun 1;116(3):s71-s76. doi: 10.5546/aap.2018.s71. Spanish.
- Background: PubMed 12063524Horak F, Stubner UP, Zieglmayer R, Harris AG. Effect 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. J Allergy Clin Immunol. 2002 Jun;109(6):956-61. doi: 10.1067/mai.2002.124657.
- Background: PubMed 12642846Simons FE, Prenner BM, Finn A Jr; Desloratadine Study Group. Efficacy and safety of desloratadine in the treatment of perennial allergic rhinitis. J Allergy Clin Immunol. 2003 Mar;111(3):617-22. doi: 10.1067/mai.2003.168.
- Background: PubMed 23282980Mendoza de Morales T, Sanchez F. Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis. World Allergy Organ J. 2009 Apr;2(4):49-53. doi: 10.1097/WOX.0b013e31819f2105.
- Background: PubMed 27670203Wandalsen GF, Miranda C, Ensina LF, Sano F, Amazonas RB, Silva JMD, Sole D. Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial. Braz J Otorhinolaryngol. 2017 Nov-Dec;83(6):633-639. doi: 10.1016/j.bjorl.2016.08.009. Epub 2016 Sep 13.
- Background: PubMed 12962522Murdoch D, Goa KL, Keam SJ. Desloratadine: an update of its efficacy in the management of allergic disorders. Drugs. 2003;63(19):2051-77. doi: 10.2165/00003495-200363190-00010.
- Background: PubMed 19539095Bachert C. A review of the efficacy of desloratadine, fexofenadine, and levocetirizine in the treatment of nasal congestion in patients with allergic rhinitis. Clin Ther. 2009 May;31(5):921-44. doi: 10.1016/j.clinthera.2009.05.017.
- Background: PubMed 17503888Snyman JR, Potter PC, Groenewald M, Levin J; Claricort Study Group. Effect of betamethasone-loratadine combination therapy on severe exacerbations of allergic rhinitis : a randomised, controlled trial. Clin Drug Investig. 2004;24(5):265-74. doi: 10.2165/00044011-200424050-00003.
- Background: PubMed 27083101Bernstein DI, Schwartz G, Bernstein JA. Allergic Rhinitis: Mechanisms and Treatment. Immunol Allergy Clin North Am. 2016 May;36(2):261-78. doi: 10.1016/j.iac.2015.12.004. Epub 2016 Mar 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Murguía Martín, MD principal investigator
Unidad de Medicina Especializada SMA
Tobías Avendaño Santiago, MD principal investigator
Oaxaca Site Management Organization, S.C
Erika N Durón López, MD principal investigator
Centro de Investigación Médica de Aguascalientes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desloratadine / Betamethasone in fixed dose and Desloratadine in people with Allergic Rhinitis, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the magnitude of change in the TNSS over the 10-day intervention period versus the baseline, by treatment group. (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06916884, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.