Not yet recruiting NCT06577077
Efficacy/ Safety of Product CM9241GRU in Patients With Perennial Allergic Rhinitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Product CM9241GRU, Placebo.
- Who it may be relevant to
- Registry conditions: Rhinitis, Allergic, Perennial. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Clinical Trial to Evaluate the Efficacy and Safety of Product CM9241GRU in Relieving Nasal Symptoms in Perennial Allergic Rhinitis
Overview
To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.
Interventions
- Drug Product CM9241GRU
01 tablet in the morning and 01 tablet in the evening for 14 days - Drug Placebo
01 tablet in the morning and 01 tablet in the evening for 14 days
Primary outcome measures
- Absolute reduction in the evening reflective total nasal symptom score (rTNSS) [Time frame: 14 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06577077 · ACH-DCG-03(03/21)