Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT06817967
Eligibility Criteria:
Inclusion Criteria:
1. Provide signed informed consent prior to any study-specific procedures.
2. Be 18 years of age or older.
3. Use xylometazoline or oxymetazoline nasal spray at least once daily over a period of 7 days, registered before entering the clinical study.
4. Be diagnosed with RM by a medical doctor. The subject needed/wanted to wean from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline.
Exclusion Criteria:
1. Had influenza, acute or chronic rhinitis (other than RM), acute sinusitis, suppurative tonsillitis, pneumonia, or tuberculosis.
2. Had taken any medication or cold remedies to treat common colds (including Proponent Solution - Nasal Spray \[PSNS\]) within the last week.
3. Had used glucocorticoids (tablets, injections, and topical inhalers) within the last week or will need this medication during the study.
4. Had serious primary cardiovascular, kidney, liver, neurological, psychiatric, or haematological disease.
5. Had a diagnosis of asthma, chronic obstructive pulmonary disease, chronic cough, or other significant acute or chronic respiratory conditions or disorders.
6. Had an allergic disease and require daily peroral antihistamines for the treatment of the disease during the inclusion period and the study.
7. Study subject was a current smoker.
8. Nasal disorder or nasal condition as a relevant septal deviation, polyposis, chronic rhinitis, ulcer, etc., and/or reconstructive surgery, that could impair nasal breathing.
9. Had a known ongoing cancer disease.
10. Was identified by the Investigator as inappropriate to participate in this study (e.g., inability to report daily using smartphone/computer \[eDiary\]).
11. Participated in other clinical trials within the last 3 months.
12. Had known allergy or hypersensitivity to the components of the investigational product.
13. Were pregnant or nursing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06817967
Study Brief:
Protocol Section:
NCT06817967