Efficacy/ Safety of Product CM9241GRU in Patients With Perennial Allergic Rhinitis

NCT ID: NCT06577077

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-08-31

Brief Summary

To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.

Conditions

Rhinitis, Allergic, Perennial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Product CM9241GRU

Group Type: EXPERIMENTAL

Product CM9241GRU

Intervention Type: DRUG

01 tablet in the morning and 01 tablet in the evening for 14 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

01 tablet in the morning and 01 tablet in the evening for 14 days

Interventions

Product CM9241GRU

01 tablet in the morning and 01 tablet in the evening for 14 days

Intervention Type: DRUG

Placebo

01 tablet in the morning and 01 tablet in the evening for 14 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants of both sexes aged 18 and over
• Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
• Participants with a diagnosis of perennial allergic rhinitis, as determined by a history of symptoms related to non-seasonal allergen exposure for at least 9 months in the 12 months prior to the screening visit.

Exclusion Criteria

• Participants who have had nasal surgery in the six (6) months prior to the screening visit, or who have obvious external structural abnormalities that interfere with nasal airflow and are considered clinically relevant by the investigator;
• Participants with non-allergic rhinitis (e.g. vasomotor, infectious, medication or drug-induced rhinitis) or seasonal allergic rhinitis;
• Participants with a current diagnosis or history of chronic rhinosinusitis, chronic purulent postnasal drip in the two (2) years prior to the screening visit;
• Participants diagnosed with asthma requiring regular use of systemic or inhaled corticosteroids; uncontrolled asthma (ACT: 5-15); partially controlled asthma (ACT: 16-19);
• Participants with a history of immunotherapy treatment in the 2 years prior to the screening visit;
• Participants with an upper respiratory tract infection or rhinosinusitis requiring antibiotic treatment in the 14 days prior to the screening visit and the randomization visit;
• Participants with an upper respiratory tract viral infection in the 7 days prior to the screening and randomization visits;
• Participants with severe hypertension, severe coronary artery disease, arrhythmias, glaucoma, hyperthyroidism, prostatic hypertrophy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Renata Herrera

Role: CONTACT

pesquisa.clinica@ache.com.br

+55(11)97216-3958

Other Identifiers

ACH-DCG-03(03/21)

Identifier Type: -

Identifier Source: org_study_id