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Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569437
Recruitment Status : Terminated (A high percentage of patients were dropping out of the study and were not able to complete the protocol.)
First Posted : October 6, 2015
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin D Malkin, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE October 5, 2015
First Posted Date  ICMJE October 6, 2015
Results First Submitted Date  ICMJE October 31, 2017
Results First Posted Date  ICMJE January 9, 2018
Last Update Posted Date January 9, 2018
Study Start Date  ICMJE September 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
Sino-nasal Outcome Test (SNOT 22) [ Time Frame: Baseline and 12 weeks ]
a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Sino-nasal Outcome Test (SNOT 22) [ Time Frame: 12 weeks ]
a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Endoscopic Nasal Polyp Score [ Time Frame: Baseline and 12 weeks ]
    0- Absence of nasal polyps
    1. Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate
    2. Polyps reaching below the lower border of the middle turbinate
    3. Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate
    4. 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.
  • Middle Meatus Culture [ Time Frame: Baseline and 12 weeks ]
    Culture swab for the presence or absence of microbial growth
  • Subjective Symptom Composite Scoring [ Time Frame: Baseline and 12 weeks ]
    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.
  • Visual Analog Scale [ Time Frame: Baseline and 12 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps
Official Title  ICMJE The Role of Doxycycline in Management of Moderate to Severe Chronic Rhinosinusitis With Nasal Polyps
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polyp of Nasal Sinus
Intervention  ICMJE
  • 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
  • Drug: sugar pill
    placebo pill to match doxycycline
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Doxycycline
    Doxycycline plus oral methylprednisolone and nasal saline sprays
    Interventions:
    • Drug: Doxycycline
    • Drug: methylprednisolone
    • Drug: nasal saline spray
    • Drug: Flonase
  • 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.
    Interventions:
    • Drug: methylprednisolone
    • Drug: Flonase
    • Drug: sugar pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 8, 2017)
49
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2015)
90
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02569437
Other Study ID Numbers  ICMJE GCO 14-0462
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Benjamin D Malkin, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP