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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Prednisone

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 Mometasone

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.


Participant Flow:   Overall Study
    Prednisone   Topical Mometasone
STARTED   4   5 
COMPLETED   4   5 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Prednisone

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 Mometasone

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 Total of all reporting groups

Baseline Measures
   Prednisone   Topical Mometasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   5   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.7  (16.5)   45.9  (11.5)   46.3  (14.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  50.0%      4  80.0%      6  66.7% 
Male      2  50.0%      1  20.0%      3  33.3% 


  Outcome Measures

1.  Primary:   SNOT-22 Questionnaire   [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]

2.  Secondary:   Lund-McKay Score From CT Scan   [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]

3.  Secondary:   Taskforce Symptom Inventory   [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]

4.  Secondary:   Medication Side-effect and Compliance Inventory   [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: CPRICE2@NM.ORG


Publications:

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