Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

Polyp of Nasal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02569437
• Other study ID #: GCO 14-0462
• Status: Terminated
• Phase: Phase 2
• First received: October 5, 2015
• Last updated: December 8, 2017
• Start date: September 2014
• Est. completion date: August 2016

Study information

• Verified date: December 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Polyps
• Polyp of Nasal Sinus
• Polyps

Intervention

Drug:
• Doxycycline
Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20
• methylprednisolone
oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days
• nasal saline spray
nasal saline sprays: 2 sprays each nostril three times a day
• Flonase
daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).
• sugar pill
placebo pill to match doxycycline

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Endoscopic Nasal Polyp Score	0- Absence of nasal polyps; Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate; Polyps reaching below the lower border of the middle turbinate; Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate; 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.	Baseline and 12 weeks
Secondary	Middle Meatus Culture	Culture swab for the presence or absence of microbial growth	Baseline and 12 weeks
Secondary	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.	Baseline and 12 weeks
Secondary	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.	Baseline and 12 weeks