Rhinitis, Allergic, PerennialPhase 3RESPIRENCT06577077
Efficacy/ Safety of Product CM9241GRU in Patients With Perennial Allergic Rhinitis
A Phase 3 study testing Product CM9241GRU in people with Rhinitis, Allergic, Perennial, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Product CM9241GRU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy and Safety of Product CM9241GRU in Relieving Nasal Symptoms in Perennial Allergic Rhinitis
To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Product CM9241GRU, Placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product CM9241GRUDrug
01 tablet in the morning and 01 tablet in the evening for 14 days
PlaceboDrug
01 tablet in the morning and 01 tablet in the evening for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Product CM9241GRU | Experimental | Not described Receives: Drug: Product CM9241GRU |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577077
- Sponsor's protocol ID
- ACH-DCG-03(03/21)
- Acronym
- RESPIRE
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy and Safety of Product CM9241GRU in Relieving Nasal Symptoms in Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06577077
- Acronym / sponsor ID
- RESPIRE / ACH-DCG-03(03/21)
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product CM9241GRU | Experimental | Drug: Product CM9241GRU |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Product CM9241GRU01 tablet in the morning and 01 tablet in the evening for 14 days | Drug | Product CM9241GRU |
| Placebo01 tablet in the morning and 01 tablet in the evening for 14 days | Drug | Placebo |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Product CM9241GRU in people with Rhinitis, Allergic, Perennial, run by Ache Laboratorios Farmaceuticos S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata Herrera (+55(11)97216-3958, pesquisa.clinica@ache.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute reduction in the evening reflective total nasal symptom score (rTNSS) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.