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

NCT06577077 | Not Yet Recruiting Phase 3

• 1 other identifier: ACH-DCG-03(03/21)
• Study Type: interventional
• Target: 432
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

• Absolute reduction in the evening reflective total nasal symptom score (rTNSS)

  Absolute reduction in the evening reflective total nasal symptom score (rTNSS) evaluated 14 days after starting treatment compared to the baseline evening rTNSS.

  14 days

Study Arms (2)

Product CM9241GRU

EXPERIMENTAL

Drug: Product CM9241GRU

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Product CM9241GRU DRUG

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

Product CM9241GRU

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Renata Herrera

CONTACT

+55(11)97216-3958; pesquisa.clinica@ache.com.br

Study Design

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

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share