Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

NCT02569437 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO 14-0462
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyp of Nasal Sinus

Keywords

doxycycline; oral methylprednisone; sinusitis with nasal polyps

Outcome Measures

Primary Outcomes (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

  Baseline and 12 weeks

Secondary Outcomes (4)

• Endoscopic Nasal Polyp Score

  Baseline and 12 weeks

• Middle Meatus Culture

  Baseline and 12 weeks

• Subjective Symptom Composite Scoring

  Baseline and 12 weeks

• Visual Analog Scale

  Baseline and 12 weeks

Study Arms (2)

Doxycycline

EXPERIMENTAL

Doxycycline plus oral methylprednisolone and nasal saline sprays

Drug: Doxycycline; Drug: methylprednisolone; Drug: nasal saline spray; Drug: Flonase

Sugar pill

PLACEBO COMPARATOR

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

Drug: methylprednisolone; Drug: Flonase; Drug: sugar pill

Interventions

Doxycycline DRUG

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

Doxycycline

methylprednisolone DRUG

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

Doxycycline; Sugar pill

nasal saline spray DRUG

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

Doxycycline

Flonase DRUG

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

Also known as: nasal steroid spray

Doxycycline; Sugar pill

sugar pill DRUG

placebo pill to match doxycycline

Also known as: placebo

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Doxycycline; Methylprednisolone; Fluticasone; Sugars

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Androstadienes; Androstenes; Androstanes; Carbohydrates

Limitations and Caveats

Power not adequate and study is at risk for a Type II error - study was ended prior to complete sample size accrual. Study recruited high percentage of severe disease patients, thus did not accurately represent moderate disease patients.

Results Point of Contact

• Title: Dr. Benjamin Malkin
• Organization: Icahn School of Medicine at Mount Sinai

Benjamin.D.Malkin@kp.org

Study Officials

• Benjamin D Malkin, MD

  Icahns School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Satish Govindaraj, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 6, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 9, 2018
• Results First Posted: January 9, 2018

Record last verified: 2017-12

Locations

US (1)