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Trial record 23 of 26 for:    sinusitis AND Clavulanate

Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

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ClinicalTrials.gov Identifier: NCT01676415
Recruitment Status : Terminated (participants are no longer receiving intervention due to clinical logistics)
First Posted : August 30, 2012
Results First Posted : May 8, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Tan, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Rhinosinusitis Without Nasal Polyps
Interventions Drug: Prednisone
Drug: Topical mometasone
Enrollment 9
Recruitment Details Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.
Pre-assignment Details  
Arm/Group Title Prednisone Topical Mometasone
Hide Arm/Group Description

Oral steroid medication

Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study

Topical steroid medication

Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

Period Title: Overall Study
Started 4 5
Completed 4 5
Not Completed 0 0
Arm/Group Title Prednisone Topical Mometasone Total
Hide Arm/Group Description

Oral steroid medication

Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study

Topical steroid medication

Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
46.7  (16.5) 45.9  (11.5) 46.3  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
2
  50.0%
4
  80.0%
6
  66.7%
Male
2
  50.0%
1
  20.0%
3
  33.3%
1.Primary Outcome
Title SNOT-22 Questionnaire
Hide Description

The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (“nasal obstruction” and “loss of smell and taste”) ranked from 0 (not a problem) to 5 (problem as bad as it can be).

Min score= 0, Max score= 110 ("worst possible problem" on all symptoms)

Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.

Time Frame 4-6 weeks and 3 months after initiation of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisone Topical Mometasone
Hide Arm/Group Description:

Oral steroid medication

Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study

Topical steroid medication

Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

Overall Number of Participants Analyzed 4 5
Mean (Standard Error)
Unit of Measure: units on a scale
4-6 WEEKS 45.75  (6.7) 34.4  (6.0)
3 MONTHS 49  (9.3) 34.4  (8.36)
2.Secondary Outcome
Title Lund-McKay Score From CT Scan
Hide Description Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.
Time Frame 4-6 weeks and 3 months after initiation of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only a few of the patients were able to return for the follow up CT scan, therefore this measure was not analyzed.
Arm/Group Title Prednisone Topical Mometasone
Hide Arm/Group Description:

Oral steroid medication

Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study

Topical steroid medication

Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Taskforce Symptom Inventory
Hide Description Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.
Time Frame 4-6 weeks and 3 months after initiation of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.
Arm/Group Title Prednisone Topical Mometasone
Hide Arm/Group Description:

Oral steroid medication

Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study

Topical steroid medication

Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Medication Side-effect and Compliance Inventory
Hide Description The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.
Time Frame 4-6 weeks and 3 months after initiation of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.
Arm/Group Title Prednisone Topical Mometasone
Hide Arm/Group Description:

Oral steroid medication

Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study

Topical steroid medication

Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Adverse event data was collected over 3 months that patients were enrolled in the study.
Adverse Event Reporting Description The definition of adverse events/serious adverse events do not differ from the Clinical Trials definition. None of the patients in this study had an adverse event or serious adverse event.
 
Arm/Group Title Prednisone Topical Mometasone
Hide Arm/Group Description

Oral steroid medication

Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study

Topical steroid medication

Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

All-Cause Mortality
Prednisone Topical Mometasone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Prednisone Topical Mometasone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prednisone Topical Mometasone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: BRUCE TAN
Organization: NORTHWESTERN UNIVERSITY
Phone: 3126958182
Responsible Party: Bruce Tan, Northwestern University
ClinicalTrials.gov Identifier: NCT01676415     History of Changes
Other Study ID Numbers: 18369
First Submitted: August 24, 2012
First Posted: August 30, 2012
Results First Submitted: January 27, 2017
Results First Posted: May 8, 2017
Last Update Posted: March 30, 2018