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Polyp of Nasal SinusPhase 2NCT02569437

Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

A Phase 2 study testing Doxycycline, methylprednisolone and nasal saline spray in people with Polyp of Nasal Sinus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The Department of Otolaryngology at Mount Sinai is looking for adults with sinus disease with polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients may be eligible to enroll in a study offering a cutting-edge therapy to help reduce symptoms and avoid surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Polyp of Nasal Sinus
What is being tested?
Doxycycline, methylprednisolone and nasal saline spray
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
1 siteUnited States
Study dates
Sep 2014to Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Nasal polyps on nasal endoscopy.
  • The patient has moderate to severe disease, defined by moderate to severe subjective symptoms (a score greater than 3 on a 10-cm VAS).
  • The patient is at least 18 years old.
  • The patient is able to understand and give informed consent.
  • The patient has clinically diagnosed chronic rhinosinusitis with nasal polyps according to the AAO-HNS diagnostic criteria: At least 2 of the following symptoms/signs:
  • Mucopurulent drainage (anterior, posterior, or both)
Show all 10Show fewer
  • Nasal obstruction (congestion)
  • Facial pain-pressure-fullness
  • Decreased sense of smell
  • and symptoms lasting 12 weeks or longer.

Who cannot join

  • The patient has a history of treatment with oral corticosteroids in the past 4 weeks. ,
  • The patient has cystic fibrosis.
  • The patient has primary ciliary dyskinesia.
  • The patient has diabetes.
  • The patient has had sinus surgery in the past 3 months.
  • The patient has an allergy to doxycycline or related tetracyclines or glucocorticoids.
Show all 21Show fewer
  • The patient is a minor.
  • The patient is a prisoner.
  • The patient has a psychiatric illness or developmental delay, which would interfere with understanding of the study and provision of informed consent.
  • The patient is a breastfeeding mother. The effects of the drugs used in this study (doxycycline) on breast milk are unknown and thus, these patients will be excluded from the study
  • The patient has a history of HIV or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.
  • The patient is on penicillin; antacids containing aluminum, calcium, magnesium, or iron; bismuth subsalicylate; barbiturates; carbamazepine; and phenytoin; as well as tetracycline and Penthane.
  • Pregnancy. Doxycycline, a tetracycline, is a known teratogen. For this reason women of child-bearing potential are suggested to take a form of contraception for the duration that they are taking doxycycline., Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Pregnancy Testing. Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) prior to the first dose of drug. No further pregnancy tests are required since after this visit the patient will no longer be taking tetracycline after 3 weeks.
  • Women of childbearing potential are defined as follows:
  • Patients with regular menses
  • Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding
  • Women who have had a tubal ligation
  • Women are considered not to be of childbearing potential for the following reasons:
  • The patient has undergone hysterectomy and/or bilateral oophorectomy.
  • The patient is post-menopausal defined by amenorrhea for at least 1 year in a woman > 45 years old.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: The Role of Doxycycline in Management of Moderate to Severe Chronic Rhinosinusitis With Nasal Polyps

The Department of Otolaryngology at Mount Sinai is looking for adults with sinus disease with polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients may be eligible to enroll in a study offering a cutting-edge therapy to help reduce symptoms and avoid surgery. The treatment combines an antibiotic (doxycycline) with oral steroids. Oral steroids are the mainstay of medical management for patients with CRSwNP. However, recent studies have shown that doxycycline helps improve symptoms as well by reducing inflammation and killing common bacteria that can cause symptoms. This study is the first to evaluate this combination regimen.

Read the detailed description

An eligible patient may be treated with either doxycycline and oral steroids OR placebo (sugar pill) and oral steroids for three weeks. Volunteers will participate in the study for to 12 weeks, and will have 4 research visits of 1 hour duration. At each study visit, the patient will under go an endoscopic evaluation and asked to complete a questionnaire describing symptoms. There is no additional cost to be enrolled in the study.

Being tested
Doxycycline, methylprednisolone, nasal saline spray, Flonase, sugar pill
Keywords
doxycycline, oral methylprednisone, sinusitis with nasal polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxycyclineDrug

    Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20

  • methylprednisoloneDrug

    oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days

  • nasal saline sprayDrug

    nasal saline sprays: 2 sprays each nostril three times a day

  • FlonaseDrug

    Also called nasal steroid spray

    daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).

  • sugar pillDrug

    Also called placebo

    placebo pill to match doxycycline

Study groups in NCT02569437
Study groupRoleWhat they receive
DoxycyclineExperimentalDoxycycline plus oral methylprednisolone and nasal saline sprays
Receives: Drug: Doxycycline; Drug: methylprednisolone; Drug: nasal saline spray; Drug: Flonase
Sugar pillPlacebo comparatorplacebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Receives: Drug: methylprednisolone; Drug: Flonase; Drug: sugar pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sino-nasal Outcome Test (SNOT 22)

    a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome

    Measured: Baseline and 12 weeks

Secondary outcomes (4)

  1. Endoscopic Nasal Polyp Score

    0- Absence of nasal polyps

    1. Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate
    2. Polyps reaching below the lower border of the middle turbinate
    3. Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate
    4. Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate Nasal polyp scores. The score is determined for each nostril, and the two scores added for a total nasal polyp score. Range of 0 to 8, graded on a size system from 0 to 4 and summed from the right and left nostrils.

    Measured: Baseline and 12 weeks

  2. Middle Meatus Culture

    Culture swab for the presence or absence of microbial growth

    Measured: Baseline and 12 weeks

  3. Subjective Symptom Composite Scoring

    A subjective symptom score will be extracted from the patient's score (on a scale of 0-5, where 0 defines no problems with the given symptom and 5 defines maximal problems ) on the SNOT-22 for each fo the following symptoms: "blockage/congestion," "runny nose," "post-nasal discharge," "facial pain/pressure," and "sense of taste/smell." Range of 0 to 25, with higher score reflecting worse symptoms.

    Measured: Baseline and 12 weeks

  4. Visual Analog Scale

    The visual analog scale for overall symptoms will be used to define disease severity. Range of 0 to 10. As per the European Position Paper 2012, mild, moderate, and severe disease will be defined as 0 to and including 3, > 3 to and including 7, and > 7 to and including 10, respectively.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Why it stopped: A high percentage of patients were dropping out of the study and were not able to complete the protocol.

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569437
Sponsor's protocol ID
GCO 14-0462
Status last verified
Dec 2017
First submitted
5 Oct 2015
Last updated
9 Jan 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxycycline, methylprednisolone and nasal saline spray in people with Polyp of Nasal Sinus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

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 10 inclusion and 21 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: stopped early, as of the sponsor's last update on 9 Jan 2018. 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 United States. 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?

Yes. Results are posted in the registry (first posted 9 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sino-nasal Outcome Test (SNOT 22) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02569437.

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 9 Jan 2018.

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