Chronic Sinusitis
Conditions
Interventions
Carbocisteine &
Clarithromycin
Clarithromycin
Sponsors
GETS Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with symptoms which had persisted for more than 12 weeks, such as nasal congestion, rhinorrhea, postnasal drip and coughing 2. Patients who were found to have paranasal sinus shadowing upon simple X-ray or CT conducted after the patient displayed one or more of the symptoms in 1. 3. Patients who had at least one subjective symptom (nasal discharge, rhinorrhea, postnasal drip, nasal congestion, heaviness of head (headache), dysosmia) and at least one objective symptom (nasal mucosal redness, nasal mucosal swelling, nasal discharge, postnasal drip) at the baseline. 4. Patients with nasal polyp of score 0 or 1 in severity 5. Outpatients 6. Patients 20 years old or above when submitting informed consent 7. Patients with the ability to understand the QOL question items 8. Patients giving written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who cannot tolerate carbocisteine or clarithromycin 2. Patients who received airway disease drugs (e.g. mucolytic agents) or 14-membered macrolides within 2 weeks prior to the start of the study 3. Patients who at the start of the study were scheduled to later receive anti-inflammatory enzyme, steroids (oral, inhalation, injection, nasal spray), anti-allergic agents, or Chinese herbal medicine 4. Patients participating in other studies at the start of this study 5. Patients who have undergone radical sinus surgery 6. Patients who have undergone endoscopic sinus surgery within 12 weeks prior to the start of the study 7. Patients who have or are suspected to have paranasal mycosis 8. Patients with complications of bronchial asthma 9.Patients with history of severe cardiovascular disease 10. Patients with a complication of malignant tumor 11.Women who are or may be pregnant 12.Patients considered inappropriate by the physicians in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effect (after 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SNOT-20 improvement factor 2. CT scoring 3. Clinical effect(4 weeks, 8 weeks later) 4. Subjective symptoms 5. Objective symptoms | — |
Countries
Japan
Contacts
Public ContactMichiaki Ota
Kyorin Pharmaceutical Co.,LTD P.L.C. Management Department
Outcome results
None listed