Trial Outcomes & Findings for Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps (NCT NCT02569437)

NCT ID: NCT02569437

Last Updated: 2018-01-09

Results Overview

a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2018-01-09

Participant Flow

Subjects were recruited from September 2014 to April 2016 at the Mount Sinai Department of Otolaryngology-Head \& Neck Surgery rhinology practice.

Participant milestones

Participant milestones
Measure	Doxycycline 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).	Sugar Pill 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
Overall Study STARTED	24	25
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	12	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxycycline 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).	Sugar Pill 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
Overall Study Lost to Follow-up	12	14

Baseline Characteristics

Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxycycline n=24 Participants Doxycycline plus oral methylprednisolone and nasal saline sprays	Sugar Pill n=25 Participants placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.	Total n=49 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 13.8 • n=5 Participants	44.1 years STANDARD_DEVIATION 12.2 • n=7 Participants	47.7 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Number of Participants with Prior Endoscopic Sinus Surgery (ESS)	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: 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.

a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome

Outcome measures

Outcome measures
Measure	Doxycycline n=24 Participants Doxycycline plus oral methylprednisolone and nasal saline sprays	Sugar Pill n=25 Participants placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Sino-nasal Outcome Test (SNOT 22) Baseline	55.2 units on a scale Standard Deviation 24.3	54.4 units on a scale Standard Deviation 20.8
Sino-nasal Outcome Test (SNOT 22) 12 weeks	43.7 units on a scale Standard Deviation 6.2	49.8 units on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: There were 12 subject withdrawals in the treatment group and 14 in the placebo group.

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.

Outcome measures

Outcome measures
Measure	Doxycycline n=24 Participants Doxycycline plus oral methylprednisolone and nasal saline sprays	Sugar Pill n=25 Participants placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Endoscopic Nasal Polyp Score Baseline	6.0 units on a scale Standard Deviation 1.8	6.5 units on a scale Standard Deviation 1.3
Endoscopic Nasal Polyp Score 12 weeks	4.3 units on a scale Standard Deviation 0.5	4.9 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Culture swab for the presence or absence of microbial growth

Outcome measures

Outcome measures
Measure	Doxycycline n=24 Participants Doxycycline plus oral methylprednisolone and nasal saline sprays	Sugar Pill n=25 Participants placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Middle Meatus Culture Culture growth at initial visit and 12 week visit	5 Participants	2 Participants
Middle Meatus Culture Culture growth initial visit, none at 12 weeks	1 Participants	2 Participants
Middle Meatus Culture No growth initial visit, but growth at 12 weeks	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: There were 12 subject withdrawals in the treatment group and 14 in the placebo group.

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.

Outcome measures

Outcome measures
Measure	Doxycycline n=24 Participants Doxycycline plus oral methylprednisolone and nasal saline sprays	Sugar Pill n=25 Participants placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Subjective Symptom Composite Scoring Baseline	16.3 units on a scale Standard Deviation 5.2	17.1 units on a scale Standard Deviation 4.4
Subjective Symptom Composite Scoring 12 weeks	11.9 units on a scale Standard Deviation 1.5	13.6 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: There were 12 subject withdrawals in the treatment group and 14 in the placebo group.

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.

Outcome measures

Outcome measures
Measure	Doxycycline n=24 Participants Doxycycline plus oral methylprednisolone and nasal saline sprays	Sugar Pill n=25 Participants placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Visual Analog Scale Baseline	8.4 units on a scale Standard Deviation 1.5	8.1 units on a scale Standard Deviation 1.3
Visual Analog Scale 12 weeks	5.2 units on a scale Standard Deviation 0.7	4.5 units on a scale Standard Deviation 0.7

Adverse Events

Doxycycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benjamin Malkin

Icahn School of Medicine at Mount Sinai

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place