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

NCT06577077 — Phase 3, Unknown, 432 participants, Ache Laboratorios Farmaceuticos S.A.

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Randomized Clinical Trial to Evaluate the Efficacy and Safety of Product CM9241GRU in Relieving Nasal Symptoms in Perennial Allergic Rhinitis

Registry	NCT06577077, acronym RESPIRE
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	432 (Estimated)
Sponsor	Ache Laboratorios Farmaceuticos S.A. (Industry)
Conditions	Rhinitis, Allergic, Perennial
Interventions	Product CM9241GRU, Placebo (Drug)
Dates	start 2024-09-01 (estimated), primary completion 2025-08-01 (estimated), completion 2025-08-01 (estimated), first posted 2024-08-29, last updated 2024-08-29

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Product CM9241GRU	Experimental	Drug: Product CM9241GRU
Placebo	Placebo comparator	Drug: Placebo

Product CM9241GRU (Drug): 01 tablet in the morning and 01 tablet in the evening for 14 days
Placebo (Drug): 01 tablet in the morning and 01 tablet in the evening for 14 days

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.