Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00480298
• Date of registration: 25/05/2007
• Primary sponsor: University Hospital, Ghent
• Public title: Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis
• Scientific title: Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis
• Date of first enrolment: November 2002
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00480298
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Belgium

Contacts

• Name: Claus Bachert, MD, PhD
• Affiliation: University Hospital, Ghent

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects must be at least 18 years of age, of either sex and any race.

- 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.

- Subjects must be in good health, free of any clinically significant disease that
would interfere with the study schedule or procedures or compromise his/her safety.

- Subjects must be willing to give informed consent and adhere to visit schedules,
medication restrictions, and agree to perform daily diary entries.

- Subjects with concurrent asthma must be maintained on no more than 1000 mcg/day BDP
or the equivalent

- Nonpregnant women of childbearing potential must use a medically acceptable, adequate
form of birth control. This includes: a) hormonal contraceptive as prescribed by a
physician (eg, oral combined, hormonal implant, depot injectable); b) medically
prescribed IUD; c) condom in combination with a spermicide; d) 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 three months prior to 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
one year postmenopausal are considered not to be of childbearing potential. However,
all female subjects must have a urine pregnancy test prior to 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 above

Exclusion Criteria:

- Women must not be pregnant, breast feeding, or premenarcheal.

- Subjects who have required a burst of oral corticosteroids within the previous three
months prior to Screening are excluded from the study.

- Subjects with systemic fungoid infections, known allergic reaction on
methylprednisolon or tetracyclines, hypertension, diabetes (type 1 and 2), glaucoma,
children, tuberculosis, herpes infection, zona oftalmica.

- Subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a
nasal or upper respiratory tract infection within two weeks of the Screening Visit
are excluded.

- Subjects with cystic fibrosis, primary ciliary's dysfunction or Kartagener's syndrome
by history are excluded.

- Subjects must not have been diagnosed with a parasitic infection.

- 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.

- Subjects must not have had an acute asthmatic attack requiring admission to a
hospital (excluding emergency room visits which resulted in direct discharge without
hospitalization) within the four weeks prior to Screening.

- Subjects must not have received immunotherapy within the previous three months.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Nasal Polyposis

Intervention(s)

Drug: Administration of oral methylprednisolone

Primary Outcome(s)

endoscopic evaluation of the nasal polyp size compared to baseline [Time Frame: at visit 2 and 4]

Secondary Outcome(s)

Nasal Polyp score: endoscopic evaluation of the nasal polyp size compared to baseline. Nasal polyposis signs and symptoms including nasal discharge, nasal congestion, postnasal drip, sense of smell,olfactory test (sites Gent, Stockholm and Huddinge) and

Secondary ID(s)

2002/067

Source(s) of Monetary Support

Please refer to primary and secondary sponsors