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Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Polyp of Nasal Sinus
Interventions Drug: Doxycycline
Drug: methylprednisolone
Drug: nasal saline spray
Drug: Flonase
Drug: sugar pill
Enrollment 49
Recruitment Details Subjects were recruited from September 2014 to April 2016 at the Mount Sinai Department of Otolaryngology—Head & Neck Surgery rhinology practice.
Pre-assignment Details  
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description

Doxycycline plus oral methylprednisolone and nasal saline sprays

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).

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

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

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

sugar pill: placebo pill to match doxycycline

Period Title: Overall Study
Started 24 25
Completed 12 11
Not Completed 12 14
Reason Not Completed
Lost to Follow-up             12             14
Arm/Group Title Doxycycline Sugar Pill Total
Hide Arm/Group Description Doxycycline plus oral methylprednisolone and nasal saline sprays placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays. Total of all reporting groups
Overall Number of Baseline Participants 24 25 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 49 participants
51.5  (13.8) 44.1  (12.2) 47.7  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 49 participants
Female
10
  41.7%
13
  52.0%
23
  46.9%
Male
14
  58.3%
12
  48.0%
26
  53.1%
Number of Participants with Prior Endoscopic Sinus Surgery (ESS)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 49 participants
13
  54.2%
13
  52.0%
26
  53.1%
1.Primary Outcome
Title Sino-nasal Outcome Test (SNOT 22)
Hide Description a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An additional 7 patients in the treatment group and 10 patients in the placebo group completed SNOT-22 scores via phone calls, even after study withdrawal.
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:
Doxycycline plus oral methylprednisolone and nasal saline sprays
placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 24 participants 25 participants
55.2  (24.3) 54.4  (20.8)
12 weeks Number Analyzed 19 participants 21 participants
43.7  (6.2) 49.8  (5.8)
2.Secondary Outcome
Title Endoscopic Nasal Polyp Score
Hide Description

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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There were 12 subject withdrawals in the treatment group and 14 in the placebo group.
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:
Doxycycline plus oral methylprednisolone and nasal saline sprays
placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 24 participants 25 participants
6.0  (1.8) 6.5  (1.3)
12 weeks Number Analyzed 12 participants 11 participants
4.3  (0.5) 4.9  (0.5)
3.Secondary Outcome
Title Middle Meatus Culture
Hide Description Culture swab for the presence or absence of microbial growth
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:
Doxycycline plus oral methylprednisolone and nasal saline sprays
placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Overall Number of Participants Analyzed 24 25
Measure Type: Count of Participants
Unit of Measure: Participants
Culture growth at initial visit and 12 week visit
5
  20.8%
2
   8.0%
Culture growth initial visit, none at 12 weeks
1
   4.2%
2
   8.0%
No growth initial visit, but growth at 12 weeks
2
   8.3%
1
   4.0%
4.Secondary Outcome
Title Subjective Symptom Composite Scoring
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There were 12 subject withdrawals in the treatment group and 14 in the placebo group.
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:
Doxycycline plus oral methylprednisolone and nasal saline sprays
placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 24 participants 25 participants
16.3  (5.2) 17.1  (4.4)
12 weeks Number Analyzed 12 participants 11 participants
11.9  (1.5) 13.6  (1.4)
5.Secondary Outcome
Title Visual Analog Scale
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There were 12 subject withdrawals in the treatment group and 14 in the placebo group.
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:
Doxycycline plus oral methylprednisolone and nasal saline sprays
placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 24 participants 25 participants
8.4  (1.5) 8.1  (1.3)
12 weeks Number Analyzed 12 participants 11 participants
5.2  (0.7) 4.5  (0.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description Doxycycline plus oral methylprednisolone and nasal saline sprays placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
All-Cause Mortality
Doxycycline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxycycline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/25 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Benjamin Malkin
Organization: Icahn School of Medicine at Mount Sinai
Responsible Party: Benjamin D Malkin, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02569437     History of Changes
Other Study ID Numbers: GCO 14-0462
First Submitted: October 5, 2015
First Posted: October 6, 2015
Results First Submitted: October 31, 2017
Results First Posted: January 9, 2018
Last Update Posted: January 9, 2018