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NCT Number: NCT06577077

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Absolute reduction in the evening reflective total nasal symptom score (rTNSS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Renata Herrera

CONTACT

[email protected]

+55(11)97216-3958

Sponsors and collaborators

Lead sponsor

Ache Laboratorios Farmaceuticos S.A.

Industry

Registry information

Official study title

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

Acronym: RESPIRE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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