About this trial
To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Parallel
Treatments tested in this trial
Product CM9241GRU
Drug01 tablet in the morning and 01 tablet in the evening for 14 days
Placebo
Drug01 tablet in the morning and 01 tablet in the evening for 14 days
Treatment groups
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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