Allergic RhinitisPhase 3ALERZINNCT05637710
Parallel, Double-dummy, Superiority Study Levocetirizine/Pseudoephedrine x Zina for Allergic Rhinitis in Brazil
A Phase 3 study testing Administration of investigation of Eurofarma drug and Administration of Comparator in people with Allergic Rhinitis, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
AR is the most common respiratory disease worldwide and is clinically defined by the presence of nasal symptoms induced by exposure to allergens, particularly nasal obstruction and pruritus, runny nose and sneezing. The treatment purpose is to prevent or alleviate symptoms as safely and effectively as possible. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Administration of investigation of Eurofarma drug and Administration of Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2026to May 2027
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sexes who meet all of the following criteria will be enrolled in the study:
- Signature of the Informed Consent Form (ICF) for those over 18 years of age and, when applicable, signature of the Informed Assent Form (IAF) by the participant under 18 years of age and the ICF by the legal representative before any study procedure.
- Age ≥ 12 years and ≤ 65 years and weight ≥ 40 kg.
- Clinical diagnosis of intermittent or persistent allergic rhinitis according to the definition of the Allergic Rhinitis and its Impact on Asthma2 (ARIA) group (Attachment 1) for at least two (02) years.
Who cannot join
- Patients who meet at least one of the following criteria will be excluded from the study:
- Concomitant presence of other types of rhinitis (such as infectious rhinitis, drug rhinitis, rhinitis in the elderly, hormonal rhinitis, non-allergic occupational rhinitis) when known.
- Presence of significant septal deviation, compatible with impaired nasal ventilatory function, at the discretion of the investigator.
- Presence of nasal polyposis on anterior rhinoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter,Randomized,Parallel,Double-blind,Double-dummy,Comparative Superiority Study of Levocetirizine 5mg / Pseudoephedrine 240mg From Eurofarma vs Zina®5mg in the Symptomatic of Allergic Rhinitis
AR is the most common respiratory disease worldwide and is clinically defined by the presence of nasal symptoms induced by exposure to allergens, particularly nasal obstruction and pruritus, runny nose and sneezing. The treatment purpose is to prevent or alleviate symptoms as safely and effectively as possible. Above all, it is recommended that patients avoid contact with allergens to which they are sensitive. However, this is often not enough, and pharmacological interventions are often required.
H1 antihistamines (anti-H1) are considered first-line drugs in the treatment of AR1. These drugs effectively relieve symptoms of the immediate phase of AR, such as nasal pruritus, sneezing, runny nose and associated eye symptoms, and partially the nasal blockage characteristic of the late phase of the disease. Due to their excellent safety profile and therapeutic advantages in the treatment of AR, second-generation anti-H1 drugs, such as levocetirizine, should always be prioritized over older compounds in all age groups1.
Read more
The combined administration of an antihistamine and an oral decongestant was shown to b more effective than the administration of an antihistamine alone for the relief of AR-associated nasal obstruction1.
Levocetirizine is an active pharmaceutical ingredient (API) registered in the country as a monodrug for oral administration at a dose of 5mg. Pseudoephedrine is not marketed as a monodrug for oral use in our area, but it is registered in FDC with antihistamines, which is why there is no comparator arm treating with pseudoephedrine only. These products are widely used and their efficacy and safety are well known in daily clinical practice in the proposed indication.
Once the absence of a pharmacokinetic interaction between levocetirizine and pseudoephedrine has been confirmed in relative bioavailability studies (RBA), this phase 3 study will be conducted in order to demonstrate the superiority of FDC levocetirizine 5mg / pseudoephedrine 240mg over levocetirizine 5mg administered alone in the symptomatic treatment of AR, particularly with regard to nasal obstruction. The registration seeks to provide a new effective and safe therapeutic option to address these cases.
Read the detailed description
The investigational drug consists of a fixed-dose combination (FDC) that contains levocetirizine, a second-generation anti-H1 antihistamine agent, and pseudoephedrine, an oral decongestant, in doses of 5mg and 240mg, respectively, in the dosage form of film-coated tablets. This product is an unprecedented FDC in the country that is indicated for the symptomatic treatment of allergic rhinitis (AR) in patients aged ≥ 12 years.
A multicenter, randomized, parallel-group, double-blind, double-dummy, superiority, active-controlled clinical trial.
Adolescents and adults (aged ≥ 12 years) of both sexes with intermittent or persistent AR will be randomized in a 1:1 ratio to receive the investigational drug (FDC levocetirizine 5mg / pseudoephedrine 240mg from Eurofarma Laboratórios S.A.) or levocetirizine 5mg (Zina®), once daily (morning), for seven (07) days.
The severity of nasal allergy symptoms in the last 24 hours (nasal obstruction, runny nose, sneezing and nasal pruritus) will be evaluated through the application of the assessment questionnaire for nasal symptoms in the last 24 hours before, during and at the end of treatment. The severity of the nasal obstruction at that timepoint will also be evaluated immediately before and one (01) hour after the administration of the first dose of the study treatment, carried out at the research site (also in the morning). Participants will be monitored for an additional seven (07) days for safety assessment.
- Conditions
- Allergic Rhinitis
- Being tested
- Administration of investigation of Eurofarma drug, Administration of Comparator
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of investigation of Eurofarma drugDrug
Also called Investigation drug
Participants randomized to this group will receive one (01) film-coated tablet of the investigational drug + one (01) levocetirizine placebo tablet, once a day, for seven (07) days.
Administration of ComparatorDrug
Also called Comparator drug
Participants randomized to this group will receive one (01) levocetirizine 5mg tablet (Zina® 5mg) + one (01) FDC placebo tablet, once daily, for seven (07) days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Investigational group: FDC levocetirizine 5mg / pseudoephedrine 240mg from Eurofarma Laboratórios S.A. Receives: Drug: Administration of investigation of Eurofarma drug |
| Group 2 | Active comparator | Comparator group: Levocetirizine 5mg (Zina® - comparator drug) Receives: Drug: Administration of Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
Absolute variation of the nasal obstruction score in the last 24 hours (VEON24D7) determined seven (07) days after the ingestion of the first dose of the IP in relation to the baseline score (VEON24D7 = EON24D7 - EON24D0), and the nasal obstruction scores correspond to the severity of this symptom in the last 24 hours (question 1 of the assessment questionnaire for nasal symptoms in the last 24 hours) and are evaluated on a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate and 3 = severe).
Measured: In the last 24 hours determined seven (07) days after the ingestion of the first dose
Secondary outcomes (1)
Secondary efficacy endpoints
- Absolute variation of the nasal obstruction score at that timepoint (VEONm1h) determined one (01) hour after the ingestion of the first dose of the IP in relation to the baseline score (VEONm1h = NEOm1h - NEOm0h), and the nasal obstruction scores at that timepoint correspond to the severity of this symptom at the time of evaluation and are evaluated on a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate and 3 = severe).
Measured: Absolute variation of the nasal obstruction score at that timepoint determined one (01) hour after the ingestion of the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study startMar 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Strategic change in development priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants who meet all eligibility criteria will be randomized to one of the following treatment groups: Investigational group: FDC levocetirizine 5mg / pseudoephedrine 240mg from Eurofarma Laboratórios S.A. (investigational drug) Participants randomized to this group will receive one (01) film-coated tablet of the investigational drug + one (01) levocetirizine placebo tablet, once a day, for seven (07) days. Comparator group: Levocetirizine 5mg (Zina® - comparator drug) Participants randomized to this group will receive one (01) levocetirizine 5mg tablet (Zina® 5mg) + one (01) FDC placebo tablet, once daily, for seven (07) days.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637710
- Sponsor's protocol ID
- EF180
- Acronym
- ALERZIN
- Status last verified
- May 2025
- First submitted
- 22 Nov 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter,Randomized,Parallel,Double-blind,Double-dummy,Comparative Superiority Study of Levocetirizine 5mg / Pseudoephedrine 240mg From Eurofarma vs Zina®5mg in the Symptomatic of Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05637710
- Acronym / sponsor ID
- ALERZIN / EF180
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic change in development priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Dec 2022 (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.
AR is the most common respiratory disease worldwide and is clinically defined by the presence of nasal symptoms induced by exposure to allergens, particularly nasal obstruction and pruritus, runny nose and sneezing. The treatment purpose is to prevent or alleviate symptoms as safely and effectively as possible. Above all, it is recommended that patients avoid contact with allergens to which they are sensitive. However, this is often not enough, and pharmacological interventions are often required.
H1 antihistamines (anti-H1) are considered first-line drugs in the treatment of AR1. These drugs effectively relieve symptoms of the immediate phase of AR, such as nasal pruritus, sneezing, runny nose and associated eye symptoms, and partially the nasal blockage characteristic of the late phase of the disease. Due to their excellent safety profile and therapeutic advantages in the treatment of AR, second-generation anti-H1 drugs, such as levocetirizine, should always be prioritized over older compounds in all age groups1.
The combined administration of an antihistamine and an oral decongestant was shown to b more effective than the administration of an antihistamine alone for the relief of AR-associated nasal obstruction1.
Levocetirizine is an active pharmaceutical ingredient (API) registered in the country as a monodrug for oral administration at a dose of 5mg. Pseudoephedrine is not marketed as a monodrug for oral use in our area, but it is registered in FDC with antihistamines, which is why there is no comparator arm treating with pseudoephedrine only. These products are widely used and their efficacy and safety are well known in daily clinical practice in the proposed indication.
Once the absence of a pharmacokinetic interaction between levocetirizine and pseudoephedrine has been confirmed in relative bioavailability studies (RBA), this phase 3 study will be conducted in order to demonstrate the superiority of FDC levocetirizine 5mg / pseudoephedrine 240mg over levocetirizine 5mg administered alone in the symptomatic treatment of AR, particularly with regard to nasal obstruction. The registration seeks to provide a new effective and safe therapeutic option to address these cases.
Detailed description
The investigational drug consists of a fixed-dose combination (FDC) that contains levocetirizine, a second-generation anti-H1 antihistamine agent, and pseudoephedrine, an oral decongestant, in doses of 5mg and 240mg, respectively, in the dosage form of film-coated tablets. This product is an unprecedented FDC in the country that is indicated for the symptomatic treatment of allergic rhinitis (AR) in patients aged ≥ 12 years.
A multicenter, randomized, parallel-group, double-blind, double-dummy, superiority, active-controlled clinical trial.
Adolescents and adults (aged ≥ 12 years) of both sexes with intermittent or persistent AR will be randomized in a 1:1 ratio to receive the investigational drug (FDC levocetirizine 5mg / pseudoephedrine 240mg from Eurofarma Laboratórios S.A.) or levocetirizine 5mg (Zina®), once daily (morning), for seven (07) days.
The severity of nasal allergy symptoms in the last 24 hours (nasal obstruction, runny nose, sneezing and nasal pruritus) will be evaluated through the application of the assessment questionnaire for nasal symptoms in the last 24 hours before, during and at the end of treatment. The severity of the nasal obstruction at that timepoint will also be evaluated immediately before and one (01) hour after the administration of the first dose of the study treatment, carried out at the research site (also in the morning). Participants will be monitored for an additional seven (07) days for safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants who meet all eligibility criteria will be randomized to one of the following treatment groups: Investigational group: FDC levocetirizine 5mg / pseudoephedrine 240mg from Eurofarma Laboratórios S.A. (investigational drug) Participants randomized to this group will receive one (01) film-coated tablet of the investigational drug + one (01) levocetirizine placebo tablet, once a day, for seven (07) days. Comparator group: Levocetirizine 5mg (Zina® - comparator drug) Participants randomized to this group will receive one (01) levocetirizine 5mg tablet (Zina® 5mg) + one (01) FDC placebo tablet, once daily, for seven (07) days.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Administration of investigation of Eurofarma drugInvestigational group: FDC levocetirizine 5mg / pseudoephedrine 240mg from Eurofarma Laboratórios S.A. |
| Group 2 | Active comparator | Drug: Administration of ComparatorComparator group: Levocetirizine 5mg (Zina® - comparator drug) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes who meet all of the following criteria will be enrolled in the study:
- Signature of the Informed Consent Form (ICF) for those over 18 years of age and, when applicable, signature of the Informed Assent Form (IAF) by the participant under 18 years of age and the ICF by the legal representative before any study procedure.
- Age ≥ 12 years and ≤ 65 years and weight ≥ 40 kg.
- Clinical diagnosis of intermittent or persistent allergic rhinitis according to the definition of the Allergic Rhinitis and its Impact on Asthma2 (ARIA) group (Attachment 1) for at least two (02) years.
Key exclusion criteria (4 listed)
- Concomitant presence of other types of rhinitis (such as infectious rhinitis, drug rhinitis, rhinitis in the elderly, hormonal rhinitis, non-allergic occupational rhinitis) when known.
- Presence of significant septal deviation, compatible with impaired nasal ventilatory function, at the discretion of the investigator.
- Presence of nasal polyposis on anterior rhinoscopy.
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 |
|---|---|---|
| Administration of investigation of Eurofarma drugAlso: Investigation drugParticipants randomized to this group will receive one (01) film-coated tablet of the investigational drug + one (01) levocetirizine placebo tablet, once a day, for seven (07) days. | Drug | Group 1 |
| Administration of ComparatorAlso: Comparator drugParticipants randomized to this group will receive one (01) levocetirizine 5mg tablet (Zina® 5mg) + one (01) FDC placebo tablet, once daily, for seven (07) days. | Drug | Group 2 |
Primary outcome
Primary efficacy endpoint
Time frame: In the last 24 hours determined seven (07) days after the ingestion of the first dose
Absolute variation of the nasal obstruction score in the last 24 hours (VEON24D7) determined seven (07) days after the ingestion of the first dose of the IP in relation to the baseline score (VEON24D7 = EON24D7 - EON24D0), and the nasal obstruction scores correspond to the severity of this symptom in the last 24 hours (question 1 of the assessment questionnaire for nasal symptoms in the last 24 hours) and are evaluated on a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate and 3 = severe).
1 secondary outcome
Secondary efficacy endpoints
Time frame: Absolute variation of the nasal obstruction score at that timepoint determined one (01) hour after the ingestion of the first dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Administration of investigation of Eurofarma drug and Administration of Comparator in people with Allergic Rhinitis, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Dec 2025. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Primary efficacy endpoint (time frame: In the last 24 hours determined seven (07) days after the ingestion of the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.