Trial Outcomes & Findings for Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery (NCT NCT02182492)

Results Overview

The treatment will begin one week after ESS. Symptoms visual analog scores (VAS) were recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. All of the patients were assessed by using symptom questionnaire after enrollment and at follow-up visits. Subjective symptoms were scored by patients on a VAS of 0-10, with 0 being "no complaint whatsoever" and 10 being "the worst imaginable complaint."Five major symptoms were focused on: nasal obstruction, rhinorrhea, loss of sense of smell, facial pain or pressure, and headache. Total VAS score was calculated based on the sum of VAS scores of these five symptom domains. Total subjective symptoms VAS range: 0\~50, with higher scores indicating greater severity of symptoms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

187 participants

Primary outcome timeframe

Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.

Results posted on

2018-09-25

Participant Flow

Patients meeting the Chronic rhinosinusitis (CRS) diagnostic criteria outlined in the European Position Paper on Rhinosinusitis and Nasal polyps (EP3OS) definition were enrolled. Three subtypes CRS included: CRS without nasal polyps (CRSsNP); non-eosinophilic CRS with nasal polyps (Non-Eos CRSwNP); eosinophilic CRS with nasal polyps (Eos CRSwNP).

Participant milestones

Participant milestones
Measure	Glucocorticoid Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months	Clarithromycin Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months
Overall Study STARTED	93	94
Overall Study COMPLETED	86	86
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glucocorticoid n=93 Participants Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months	Clarithromycin n=94 Participants Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months	Total n=187 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants	86 Participants n=7 Participants	170 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	40.4 years STANDARD_DEVIATION 12.6 • n=5 Participants	39.9 years STANDARD_DEVIATION 14.2 • n=7 Participants	40.2 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	42 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	52 Participants n=7 Participants	107 Participants n=5 Participants
Region of Enrollment China	93 participants n=5 Participants	94 participants n=7 Participants	187 participants n=5 Participants

PRIMARY outcome

Timeframe: Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.

Population: A total of 187 patients met the study eligibility criteria. Seven patients in fluticasone propionate group and 8 patients in clarithromycin group dropped out because of nonadherence.

The treatment will begin one week after ESS. Symptoms visual analog scores (VAS) were recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. All of the patients were assessed by using symptom questionnaire after enrollment and at follow-up visits. Subjective symptoms were scored by patients on a VAS of 0-10, with 0 being "no complaint whatsoever" and 10 being "the worst imaginable complaint."Five major symptoms were focused on: nasal obstruction, rhinorrhea, loss of sense of smell, facial pain or pressure, and headache. Total VAS score was calculated based on the sum of VAS scores of these five symptom domains. Total subjective symptoms VAS range: 0\~50, with higher scores indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	Glucocorticoid n=86 Participants Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months	Clarithromycin n=86 Participants Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months
Total Subjective Symptoms Visual Analog Scores (VAS) Baseline	20.4 score on a scale Standard Deviation 8.1	20.7 score on a scale Standard Deviation 7.8
Total Subjective Symptoms Visual Analog Scores (VAS) 1-month	9.7 score on a scale Standard Deviation 5.2	8.9 score on a scale Standard Deviation 5.0
Total Subjective Symptoms Visual Analog Scores (VAS) 3-month	7.0 score on a scale Standard Deviation 4.2	5.8 score on a scale Standard Deviation 4.3
Total Subjective Symptoms Visual Analog Scores (VAS) 6-month	5.9 score on a scale Standard Deviation 4.5	4.7 score on a scale Standard Deviation 4.2
Total Subjective Symptoms Visual Analog Scores (VAS) 12-month	5.6 score on a scale Standard Deviation 5.3	4.8 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.

Population: A total of 187 patients met the study eligibility criteria. Seven patients in fluticasone propionate group and 8 patients in clarithromycin group dropped out because of nonadherence.

Nasal endoscopic evaluation was performed by the senior investigator who remained blinded to the treatment, including poly size: 0, absence of polyps; 1, polyps in middle meatus only; 2, polyps beyond middle meatus but not blocking the nose completely; and 3, polyps completely obstructing the nose; discharge: 0, no discharge; 1, clear thin discharge; 2, thick purulent discharge; edema: 0, no edema; 1, mild edema; 2, severe edema; crusting: 0, no crusting; 1, mild crusting; 2, severe crusting; scarring: 0, no scarring; 1, mild scarring; 2, severe scarring). Each side was graded separately, and the scores from both sides were added to determine the overall scores for a particular domain. The total endoscopy score was calculated based on the sum of scores of these endoscopic domains. Endoscopic scores were also recorded before ESS (baseline) and at 1-, 3-, 6- and 12-month follow-up visits. Total endoscopy score range: 0\~22, with higher scores indicating greater severity.

Outcome measures

Outcome measures
Measure	Glucocorticoid n=86 Participants Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months	Clarithromycin n=86 Participants Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months
Total Nasal Endoscopic Scores Baseline	8.2 score on a scale Standard Deviation 2.9	7.6 score on a scale Standard Deviation 2.9
Total Nasal Endoscopic Scores 1-month	5.3 score on a scale Standard Deviation 2.3	4.7 score on a scale Standard Deviation 2.2
Total Nasal Endoscopic Scores 3-month	3.7 score on a scale Standard Deviation 2.8	3 score on a scale Standard Deviation 2.4
Total Nasal Endoscopic Scores 6-month	3.1 score on a scale Standard Deviation 2.6	2.1 score on a scale Standard Deviation 2.2
Total Nasal Endoscopic Scores 12-month	2.7 score on a scale Standard Deviation 2.6	2.1 score on a scale Standard Deviation 2.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Polyp tissues from CRSwNP patients and diseased sinus mucosa from CRSsNP patients will be collected during surgery.

Outcome measures

Outcome data not reported

Adverse Events

Glucocorticoid

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Clarithromycin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Glucocorticoid n=93 participants at risk Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months	Clarithromycin n=94 participants at risk Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months
Surgical and medical procedures Mild nasal bleeding	3.2% 3/93 • 1 year	2.1% 2/94 • 1 year
Surgical and medical procedures Mild diarrhea	1.1% 1/93 • 1 year	2.1% 2/94 • 1 year
Surgical and medical procedures Headache	1.1% 1/93 • 1 year	1.1% 1/94 • 1 year

Additional Information

Dr. Zheng Liu

Department of ENT of Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Phone: 86 027 83663807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place