Clinical trial NCT02569437: Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps
Official title: The Role of Doxycycline in Management of Moderate to Severe Chronic Rhinosinusitis With Nasal Polyps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Polyp of Nasal Sinus
Keywords: doxycycline
oral methylprednisone
sinusitis with nasal polyps
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)
  * Nasal obstruction (congestion)
  * Facial pain-pressure-fullness
  * Decreased sense of smell
  * and symptoms lasting 12 weeks or longer.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Sino-nasal Outcome Test (SNOT 22)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Endoscopic Nasal Polyp Score
timeFrame: Baseline and 12 weeks
measure: Middle Meatus Culture
timeFrame: Baseline and 12 weeks
measure: Subjective Symptom Composite Scoring
timeFrame: Baseline and 12 weeks
measure: Visual Analog Scale
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahns School of Medicine at Mount Sinai
name: Benjamin D Malkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Satish Govindaraj, MD
role: STUDY_CHAIR
References: