Chronic RhinosinusitisPhase 2DOXYPOSTOPNCT01198912
Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial
A Phase 2 study testing doxycycline 100 mg in people with Chronic Rhinosinusitis and Nasal Polyps, run by University Hospital, Ghent at 2 sites in 2 countries.
Trial summary
This is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis, Nasal Polyps
- What is being tested?
- doxycycline 100 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Nov 2011to 6 Feb 2017
- 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
- at least 18 years of age, of either sex and any race
- diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research
- Subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery
- 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.
- Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control.
Who cannot join
- Women must not be pregnant, breast feeding, or premenarcheal.
- Subjects who have required oral corticosteroids within the previous four weeks prior to surgery.
- Subjects who have required nasal corticosteroids within the previous one week prior to surgery.
- Subjects with known allergic reaction on tetracyclines, diabetes (type 1 and 2), renal insufficiency, severe liver disease, systemic diseases affecting the nose (e.g. M. Wegener), prior surgeries of the paranasal sinuses.
- Patients with the following diseases should be excluded :
- Cystic fibrosis based on positive sweat test or DNA alleles
Show all 12Show fewer
- Gross immunodeficiency (congenital or acquired)
- congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)
- Non-invasive fungal balls and invasive fungal disease
- systemic vasculitis and granulomatous diseases
- Cocaine abuse
- Neoplasia
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial.
This is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.
- Conditions
- Chronic Rhinosinusitis, Nasal Polyps
- Being tested
- placebo, doxycycline 100 mg
- Keywords
- rhinosinusitis, doxycycline, Chronic rhinosinusitis with or without nasal polyps
- Medical subject headings
- Nasal Polyps, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
during 56 days
doxycycline 100 mgDrug
during 56 days
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| doxycycline 100 mg | Experimental | Not described Receives: Drug: doxycycline 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic evaluation of quality and speed of wound healing
Measured: at 3 months after first drug intake
Recurrence of nasal polyps
Measured: at 3 months after first drug intake
Recurrence of nasal polyps
Measured: at 6 months after first drug intake
Secondary outcomes (10)
nasal and exhaled NO
Measured: at 3 months after first drug intake
nasal and exhaled NO
Measured: at 6 months after first drug intake
subjective assessment of the wound healing
Measured: at 3 months after first drug intake
subjective assessment of the wound healing
Measured: at 6 months after first drug intake
chronic rhinosinusitis symptoms by the patients
Measured: at 3 months after first drug intake
chronic rhinosinusitis symptoms by the patients
Measured: at 6 months after first drug intake
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
Measured: at 3 months after first drug intake
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
Measured: at 6 months after first drug intake
inflammatory mediators in nasal fluid as well as in serum
Measured: at 3 months after first drug intake
inflammatory mediators in nasal fluid as well as in serum
Measured: at 6 months after first drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study start22 Nov 2011
- Primary completion6 Sep 2016
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Bachert, MD, PhD, Principal investigator, University Hospital Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198912
- Sponsor's protocol ID
- 2010/384
- Acronym
- DOXYPOSTOP
- Status last verified
- Jun 2018
- First submitted
- 8 Sep 2010
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT01198912
- Acronym / sponsor ID
- DOXYPOSTOP / 2010/384
- Conditions
- Chronic Rhinosinusitis, Nasal Polyps
- Keywords
- rhinosinusitis, doxycycline, Chronic rhinosinusitis with or without nasal polyps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 22 Nov 2011 (actual)
- Primary completion
- 6 Sep 2016 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 10 Sep 2010 (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 is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| doxycycline 100 mg | Experimental | Drug: doxycycline 100 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years of age, of either sex and any race
- diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research
- Subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery
- 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.
Key exclusion criteria (12 listed)
- Women must not be pregnant, breast feeding, or premenarcheal.
- Subjects who have required oral corticosteroids within the previous four weeks prior to surgery.
- Subjects who have required nasal corticosteroids within the previous one week prior to surgery.
- Subjects with known allergic reaction on tetracyclines, diabetes (type 1 and 2), renal insufficiency, severe liver disease, systemic diseases affecting the nose (e.g. M. Wegener), prior surgeries of the paranasal sinuses.
- Patients with the following diseases should be 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 |
|---|---|---|
| placeboduring 56 days | Drug | placebo |
| doxycycline 100 mgduring 56 days | Drug | doxycycline 100 mg |
Primary outcome
Endoscopic evaluation of quality and speed of wound healing
Time frame: at 3 months after first drug intake
Recurrence of nasal polyps
Time frame: at 3 months after first drug intake
Recurrence of nasal polyps
Time frame: at 6 months after first drug intake
10 secondary outcomes
nasal and exhaled NO
Time frame: at 3 months after first drug intake
nasal and exhaled NO
Time frame: at 6 months after first drug intake
subjective assessment of the wound healing
Time frame: at 3 months after first drug intake
subjective assessment of the wound healing
Time frame: at 6 months after first drug intake
chronic rhinosinusitis symptoms by the patients
Time frame: at 3 months after first drug intake
chronic rhinosinusitis symptoms by the patients
Time frame: at 6 months after first drug intake
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
Time frame: at 3 months after first drug intake
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
Time frame: at 6 months after first drug intake
inflammatory mediators in nasal fluid as well as in serum
Time frame: at 3 months after first drug intake
inflammatory mediators in nasal fluid as well as in serum
Time frame: at 6 months after first drug intake
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 15 Jun 2018.
- website University Hospital Ghent, BelgiumLink 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, Belgium
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing doxycycline 100 mg in people with Chronic Rhinosinusitis and Nasal Polyps, run by University Hospital, Ghent at 2 sites in 2 countries.
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 6 inclusion and 12 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Germany. 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. Some participants in this study may receive a placebo. 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 quality and speed of wound healing (time frame: at 3 months after first drug intake). The study lists 3 primary outcomes in all. 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 15 Jun 2018.