A Multicenter, Randomized, Double-blind, Three-arm, Parallel Clinical Endpoint Bioequivalence Study of Monometasone Furoate Nasal Spray in Patients With Seasonal Allergic Rhinitis

Launched by ZHENG LIU ENT · Dec 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a nasal spray called Monometasone Furoate, which is being compared to a similar product to see if they work the same way for people with seasonal allergic rhinitis, commonly known as hay fever. The trial aims to evaluate how well this new nasal spray helps relieve allergy symptoms, such as nasal congestion and sneezing, during the allergy season, while also checking for any potential side effects.

To participate in the trial, you need to be a man or a non-pregnant, non-breastfeeding woman between 18 and 65 years old, with moderate to severe seasonal allergic rhinitis diagnosed by a healthcare professional. You should have had allergy symptoms for at least a year and must have tested positive for specific allergens. Participants will receive either the new nasal spray or the reference product, and they will be closely monitored to assess how effective the treatment is and for any side effects. It's important to know that certain health conditions or medications may exclude someone from participating, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men aged from 18 to 65 (including boundary value) or non-pregnant or nonlactating women shall agree.
• • Appropriate contraceptive measures during the trial (see Appendix 1 for specific measures);
• • 2. Moderate to severe seasonal allergic rhinitis patients, 1 year past history (including the main complaint), diagnosis based on reference to the diagnosis and treatment guidelines of allergic rhinitis (2022, revised), random there are one or more allergens tested positive, approved skin prick test (SPT), serum specific IgE in any allergen test results. If the allergen test report can be provided within 12 months, there is no need to repeat the item;
• • 3. The 12-h total reactive nasal symptom score (rTNSS) assessed during the screening period (Visit 1) was 6 (out of 12), and the nasal congestion score was 2;
• • 4. Prior to the start of the trial, the subjects voluntarily signed the informed consent form approved by the ethics committee;
• • 5. At screening (Visit 1), the subjects could master the correct nasal spray administration method and score the nasal symptoms as required by the protocol.
• Exclusion Criteria:
• • 1. Allergic to ometasone furoate or its excipients, or have been shown to be ineffective against ometasone furroate or other glucocorticoids; 2. Having any clinically significant serious medical history or illness that the investigator considers affects subject safety or the conduct of the trial; 3. Severe liver and renal diseases, or abnormal liver and renal function tests with clinical significance (ALT, AST\> 1.5 times of normal, times, or TBIL\> 1.5 times the upper limit of normal value with any AST, or Cre\> 1.2 times the upper limit of normal); 4. Screening of alcohol addicts or drug users in the first 2 years (Visit 1); 5. Select (Visit 1) for nasal trauma who had sinus surgery or incomplete healing within 3 months; 6. Those who have participated in other drug clinical trials and used study drugs within 3 months prior to screening (Visit 1); 7. Those who were vaccinated within 7 days prior to screening (Visit 1) or who are scheduled to be vaccinated during the trial; 8. Presof glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis or other eye infections during screening (Visit 1); 9. Local or systemic fungal, bacterial, viral or parasitic infection with active or inactive pulmonary TB infection at the screening (Visit 1), not cured and still requiring continuous treatment, the subject may be at risk of discomfort or affect the judgment of the test results; 10. Patients with asthma requiring long-term treatment (occasional acute asthma, or mild, exercise-induced asthma, unmedicated or limited to inhaled short-acting β receptor agonists during the trial (patients with a maximum of 8 doses per day can be included)); 11. Screening period or randomized anterior nasal examination results judged by the investigator of nasal diseases or symptoms / signs that may affect the intranasal drug deposition, such as acute or chronic sinusitis, chronic purulent symptoms or signs of the postnasal drip, drug rhinitis, significant nasal polyps, other clinically significant respiratory tract malformations / nasal structure abnormalities, significant nasal trauma (e. g., nasal penetration injury), or significant nasal septum deviation; 12. Patients with any nasal mucosa erosion, septal ulcer or septal perforation during screening or before randomization; 13. The following drugs and / or patients were used during the 7 half-lives before the lead-in period (see Appendix 2): vasoconstrictors (3 days), strong sedative (3 days), antihistamine (3-10 days), decongestants (3 days), leukotriene receptor antagonists (7 days), anticholines (7 days), sweet acids (14 days), systemic antibiotics (14 days), ocular mast cell stabilizers (14 days), monoamine oxidase inhibitors (14 days), tricyclic antidepressants (14 days), potent CYP3A4 Induction / inhibitor (14 days), anti-allergic Chinese herbs (14 days), Corticosteroids (14-30 days), immunotherapy (60-120 days), etc.; 14. planned use of the following drugs or / and treatment during the trial: a. potent CYP3A4 induction / inhibitor; b. Chronic or intermittent use of corticosteroids (except investigational drugs); c. antihistamines (except rescue drugs under protocol); d. leukotriene receptor antagonist; e. mast cell membrane stabilizer; f. \[\] systemic or intranasal decongestant; g. anticholinic; h. immunosuppresant; i. anti-allergic herbal / Chinese patent / health products; j. anti-IgE antibody (such as Omajumab for injection); k. nasal irrigation agent (including saline); 15. Those who plan to travel for 2 consecutive days or more than 3 days during the trial; 16. Any situation that may affect the subject's informed consent or follow the trial protocol (including compliance with the visit schedule or the diary card or questionnaire, etc.), or that the subject's participation in the trial may affect the trial results or their own safety
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