Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

NCT ID: NCT02569437

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

Polyp of Nasal Sinus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Doxycycline

Doxycycline plus oral methylprednisolone and nasal saline sprays

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

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

methylprednisolone

Intervention Type: DRUG

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

nasal saline spray

Intervention Type: DRUG

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

Flonase

Intervention Type: DRUG

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

Sugar pill

placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.

Group Type: PLACEBO_COMPARATOR

methylprednisolone

Intervention Type: DRUG

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

Flonase

Intervention Type: DRUG

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

sugar pill

Intervention Type: DRUG

placebo pill to match doxycycline

Interventions

Doxycycline

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

Intervention Type: DRUG

methylprednisolone

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

Intervention Type: DRUG

nasal saline spray

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

Intervention Type: DRUG

Flonase

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

Intervention Type: DRUG

sugar pill

placebo pill to match doxycycline

Intervention Type: DRUG

Other Intervention Names

nasal steroid spray; placebo

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Benjamin D Malkin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin D Malkin, MD

Role: PRINCIPAL_INVESTIGATOR

Icahns School of Medicine at Mount Sinai

Satish Govindaraj, MD

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 14-0462

Identifier Type: -

Identifier Source: org_study_id