Parallel, Double-dummy, Superiority Study Levocetirizine/Pseudoephedrine x Zina for Allergic Rhinitis in Brazil

NCT05637710 | Withdrawn Phase 3

• 1 other identifier: EF180
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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).

  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 determined one (01) hour after the ingestion of the first dose

Study Arms (2)

Group 1

EXPERIMENTAL

Investigational group: FDC levocetirizine 5mg / pseudoephedrine 240mg from Eurofarma Laboratórios S.A.

Drug: Administration of investigation of Eurofarma drug

Group 2

ACTIVE COMPARATOR

Comparator group: Levocetirizine 5mg (Zina® - comparator drug)

Drug: Administration of Comparator

Interventions

Administration of investigation of Eurofarma drug 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.

Also known as: Investigation drug

Group 1

Administration of 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.

Also known as: Comparator drug

Group 2

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratorios S.A

São Paulo, São Paulo, 06696-000, Brazil

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 5, 2022
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)