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

Launched by ACHE LABORATORIOS FARMACEUTICOS S.A. · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CM9241GRU for people who suffer from perennial allergic rhinitis, which is a long-lasting allergic reaction that can cause symptoms like sneezing, runny nose, and nasal congestion. The goal of the trial is to see if this treatment is effective and safe compared to a placebo, which is an inactive substance used for comparison. The trial is not yet recruiting participants, but it aims to include adults aged 18 and older who have been diagnosed with perennial allergic rhinitis for at least nine months.

To participate, individuals need to be able to understand the study and give their consent by signing a form. However, some people may not be eligible, including those who have had recent nasal surgery, have other types of rhinitis, or serious health conditions like asthma that isn’t well controlled. Participants in the trial will receive information on what to expect during the study, and they will be monitored for both the treatment's effectiveness and any potential side effects. This trial is an important step in finding new options for those struggling with chronic allergies.

Gender

ALL

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.