Allergic rhinitis, Vasomotor rhinitis
Conditions
Interventions
ENT201 or placebo will be administered into each nostril.
Sponsors
Ichikawa Narumi
Senju Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with allergic rhinitis or vasomotor rhinitis (2) Patients who have exhibited symptoms of allergic rhinitis or vasomotor rhinitis for at least two years (3) No gender restrictions (4) Patients aged 12 years or older at the time of obtaining informed consent (5) Patients who meet the eligibility criteria specified in the clinical trial protocol
Exclusion criteria
Exclusion criteria: (1) Patients with nasal conditions or infectious diseases severe enough to interfere with efficacy assessment (2) Patients who have undergone surgical procedures for the treatment of nasal symptoms within one year prior to obtaining consent (3) Patients receiving treatment that may affect the conduct of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of improvement in nasal discharge based on the nasal discharge score during the observation period and the 2 weeks after administration of treatment period I (double-blind period) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in the frequency of nose-blowing - Area under the curve for the frequency of nose-blowing - Change in nasal symptom score - Effect on the reduction of watery nasal discharge - Quality of life (QOL) - Overall satisfaction with treatment - Physiological examination - Clinical examination - Adverse events - Rebound effect - Pharmacokinetics | — |
Contacts
Public ContactNarumi Ichikawa
CEOLIA Pharma Co., Ltd.
Outcome results
None listed