Status:
NOT_YET_RECRUITING
Efficacy/ Safety of Product CM9241GRU in Patients With Perennial Allergic Rhinitis
Lead Sponsor:
Ache Laboratorios Farmaceuticos S.A.
Conditions:
Rhinitis, Allergic, Perennial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT06577077
Start Date
September 1 2024
End Date
August 1 2025
Last Update
August 29 2024
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