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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

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
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

  • Rhinitis, Allergic, Perennial
03

In context

Rhinitis, Allergic, Perennial

178 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 9 are open to participants now.

This study's planned enrollment of 432 is above the median of 135 across 157 interventional studies indexed under Rhinitis, Allergic, Perennial.

Browse Rhinitis, Allergic, Perennial studies →

Lead sponsor

Ache Laboratorios Farmaceuticos S.A. is the lead sponsor of 36 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 ; 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

06

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06577077
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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Discussion

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