Nasal PolyposisPhase 2NCT00480298
Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis
A Phase 2 study testing Administration of oral methylprednisolone in people with Nasal Polyposis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study is a double-blinded, randomized, placebo controlled, multi-center trial in which 120 subjects with nasal polyposis (NP) will be treated during 20 days with oral corticosteroids (OCS) in decreasing doses or oral doxycyclin (ODOX) or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyposis
- What is being tested?
- Administration of oral methylprednisolone
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2002to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a double-blinded, randomized, placebo controlled, multi-center trial in which 120 subjects with nasal polyposis (NP) will be treated during 20 days with oral corticosteroids (OCS) in decreasing doses or oral doxycyclin (ODOX) or placebo. At each visit the clinical and the biological activity will be assessed by nasal peak inspiratory flow (nPIF), symptoms, olfactory test, endoscopic evaluation of nasal polyps, peripheral eosinophil levels and markers of inflammation IL-5, IL-5 receptor alpha, ECP, TGFβ1, IgE and specific IgE in serum and nasal secretion.
- Conditions
- Nasal Polyposis
- Being tested
- Administration of oral methylprednisolone
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of oral methylprednisoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic evaluation of the nasal polyp size compared to baseline
Measured: at visit 2 and 4
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startNov 2002
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolyposisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Claus Bachert, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480298
- Sponsor's protocol ID
- 2002/067
- Status last verified
- Dec 2007
- First submitted
- 25 May 2007
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT00480298
- Acronym / sponsor ID
- 2002/067
- Conditions
- Nasal Polyposis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Jul 2006 (actual)
- First posted
- 30 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a double-blinded, randomized, placebo controlled, multi-center trial in which 120 subjects with nasal polyposis (NP) will be treated during 20 days with oral corticosteroids (OCS) in decreasing doses or oral doxycyclin (ODOX) or placebo. At each visit the clinical and the biological activity will be assessed by nasal peak inspiratory flow (nPIF), symptoms, olfactory test, endoscopic evaluation of nasal polyps, peripheral eosinophil levels and markers of inflammation IL-5, IL-5 receptor alpha, ECP, TGFβ1, IgE and specific IgE in serum and nasal secretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of oral methylprednisolone | Drug | – |
Primary outcome
endoscopic evaluation of the nasal polyp size compared to baseline
Time frame: at visit 2 and 4
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Bachert, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of oral methylprednisolone in people with Nasal Polyposis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic evaluation of the nasal polyp size compared to baseline (time frame: at visit 2 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007.