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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAche Laboratorios Farmaceuticos S.A.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

432 Participants
are divided into 2 treatment groups
Group A: Product CM9241GRUExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
14 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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