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Not yet recruitingNCT06577077RESPIREUpdated Aug 29, 2024

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

A Phase 3 interventional study of Product CM9241GRU and Placebo in Rhinitis, Allergic, Perennial, sponsored by Ache Laboratorios Farmaceuticos S.A.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by Ache Laboratorios Farmaceuticos S.A. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
432
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
432 participants (estimated)

Study arms

  • Experimental
    Product CM9241GRU

    Drug: Product CM9241GRU

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugProduct CM9241GRU

    01 tablet in the morning and 01 tablet in the evening for 14 days

  • DrugPlacebo

    01 tablet in the morning and 01 tablet in the evening for 14 days

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06577077
Lead sponsor
Ache Laboratorios Farmaceuticos S.A.
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Sep 2024 (estimated)
Primary completion
Aug 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Aug 29, 2024

Study contacts

Renata Herrera
Contact
pesquisa.clinica@ache.com.br
+55(11)97216-3958

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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