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

Ache Laboratorios Farmaceuticos

Status and phase: Not yet enrolling; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Placebo; Drug: Product CM9241GRU

Study type: Interventional

Funder types: Industry

Identifiers

NCT06577077

ACH-DCG-03(03/21)

Details and patient eligibility

About

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

Enrollment: 432 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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432 participants in 2 patient groups, including a placebo group

Product CM9241GRU

Experimental group

Treatment:

Drug: Product CM9241GRU

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo