Chronic rhinosinusitis with nasal polyps
Conditions
Interventions
Group A:Oral prednisolone tablets (65x5mg in 20 days)
Group B:Placebo
Sponsors
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be at least 18 years of age, of either sex, and of any race; 2. Subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the polyp scoring system; 3. Subjects must be in good health and free of any clinically significant disease that would interfere with the study schedule or procedures or compromise the subjects' safety; 4. Subjects must be willing to give informed consent and adhere to visit schedules and medication restrictions and agree to perform daily diary entries; 5. Subjects with concurrent asthma must be maintained on no more than 1000 mcg/d beclomethasone dipropionate or the equivalent; 6. Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. This includes: (1) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); (2) medically prescribed intra uterine device (IUD); (3) condom in combination with a spermicide; (4) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. They must have started this birth control method at least 3 months before screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for the duration of the study. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. Women who are surgically sterilized or are at least 1 year postmenopausal are considered not to be of childbearing potential. However, all female subjects must have a urine pregnancy test before treatment, which must be negative. Male subjects must agree to use an adequate form of birth control for the duration of the study. They must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described.
Exclusion criteria
Exclusion criteria: 1. Women who is pregnant, breast-feeding, or premenarcheal; 2. Subjects who have required a burst of oral corticosteroids within the 3 months before screening are excluded from the study; 3. Subjects with systemic fungoid infections, known allergic reaction on methylprednisolone or tetracyclines, hypertension, diabetes (type 1 and 2), glaucoma, tuberculosis, herpes infection, or zona ophtalmica are excluded, and children are excluded. Patients with antineutrophil cytoplasmic antibodies such as patients with Wegener granulomatosis, Churg-Strauss syndrome, and microscopic polyangiitis are excluded on the basis of the systemic involvement, nasal crusting, vasculitis, and septal perforation; 4. Subjects with acute sinusitis or concurrent nasal infection or subjects who have had a nasal or upper respiratory tract infection within 2 weeks of the screening visit are excluded; 5. Subjects with cystic fibrosis, primary ciliary dysfunction or Kartagener syndrome by history are excluded; 6. Subjects must not have been diagnosed with a parasitic infection; 7. Subjects must not be known to be HIV-positive or positive to hepatitis B surface antigen or C antibodies. Testing will not be done at screening; 8. Subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency department visits that resulted in direct discharge without hospitalization) within the 4 weeks before screening; 9. Subjects must not have received immunotherapy within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score, Lanza-Kennedy nasal endoscopy score; | — |
Countries
China
Contacts
Public ContactZheng Liu
Outcome results
None listed