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Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin D Malkin, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT02569437
First received: October 5, 2015
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Polyp of Nasal Sinus Drug: Doxycycline Drug: methylprednisolone Drug: nasal saline spray Drug: Flonase Drug: sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Doxycycline in Management of Moderate to Severe Chronic Rhinosinusitis With Nasal Polyps

Resource links provided by NLM:


Further study details as provided by Benjamin D Malkin, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Sino-nasal Outcome Test (SNOT 22) [ Time Frame: 12 weeks ]
    a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis


Secondary Outcome Measures:
  • Endoscopic nasal polyp score [ Time Frame: 12 weeks ]
  • Middle Meatus Culture [ Time Frame: 12 weeks ]
    Culture swab for the presence or absence of microbial growth

  • Subjective Symptom Composite Scoring [ Time Frame: 12 weeks ]
    A subjective symptom score will be extracted from the patient's score (on a scale of 0-5) 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."

  • Visual Analog Scale [ Time Frame: 12 weeks ]
    The visual analog scale for overall symptoms will be used to define disease severity. 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.


Enrollment: 48
Study Start Date: September 2014
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxycycline
Doxycycline plus oral methylprednisolone and nasal saline sprays
Drug: Doxycycline
Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20
Drug: methylprednisolone
oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days
Drug: nasal saline spray
nasal saline sprays: 2 sprays each nostril three times a day
Drug: Flonase
daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).
Other Name: nasal steroid spray
Placebo Comparator: Sugar pill
placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Drug: methylprednisolone
oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days
Drug: Flonase
daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).
Other Name: nasal steroid spray
Drug: sugar pill
placebo pill to match doxycline
Other Name: placebo

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02569437

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Benjamin D Malkin, MD Icahns School of Medicine at Mount Sinai
Study Chair: Satish Govindaraj, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Benjamin D Malkin, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02569437     History of Changes
Other Study ID Numbers: GCO 14-0462
Study First Received: October 5, 2015
Last Updated: September 12, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Benjamin D Malkin, Icahn School of Medicine at Mount Sinai:
doxycycline
oral methylprednisone
sinusitis with nasal polyps

Additional relevant MeSH terms:
Polyps
Nasal Polyps
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Doxycycline
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Fluticasone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents

ClinicalTrials.gov processed this record on June 23, 2017