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Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

Primary Purpose

Asthma, Chronic Sinusitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Sinus Surgery
medical therapy
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria: General

    1. 18 years of age or older
    2. Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status
    3. Informed consent and ability to comply with study procedures
    4. Patients must meet inclusion criteria for both asthma and sinus disease.

Inclusion criteria: Asthma

In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria:

  1. Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of >12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator).
  2. Either:

    • Asthma Control Questionnaire score > 1.5 or
    • Use of inhaled rescue ß-agonist >/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or
    • >1 hospitalization or unscheduled MD visit in the past 6 months for asthma symptoms or
    • >1 course of oral steroid use in past 6 months or
    • > 2 weeks of systemic steroids in last 6 months.

Exclusion Criteria:

  1. Current smokers or those with at least a 10 pack-year smoking history
  2. Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk

Sites / Locations

  • Evanston Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Medical therapy

Surgery

Arm Description

Patients undergo surgery 6 months after randomization

Patients undergo surgery at time of randomization

Outcomes

Primary Outcome Measures

Asthma Control Score

Secondary Outcome Measures

Full Information

First Posted
February 9, 2010
Last Updated
July 19, 2019
Sponsor
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT01066416
Brief Title
Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
Official Title
Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
July 2009 (Actual)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthShore University HealthSystem

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical therapy
Arm Type
Placebo Comparator
Arm Description
Patients undergo surgery 6 months after randomization
Arm Title
Surgery
Arm Type
Experimental
Arm Description
Patients undergo surgery at time of randomization
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Sinus Surgery
Intervention Type
Other
Intervention Name(s)
medical therapy
Intervention Description
Subjects will undergo surgery 6 months after randomization
Primary Outcome Measure Information:
Title
Asthma Control Score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria: General 18 years of age or older Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status Informed consent and ability to comply with study procedures Patients must meet inclusion criteria for both asthma and sinus disease. Inclusion criteria: Asthma In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria: Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of >12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator). Either: Asthma Control Questionnaire score > 1.5 or Use of inhaled rescue ß-agonist >/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or >1 hospitalization or unscheduled MD visit in the past 6 months for asthma symptoms or >1 course of oral steroid use in past 6 months or > 2 weeks of systemic steroids in last 6 months. Exclusion Criteria: Current smokers or those with at least a 10 pack-year smoking history Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk
Facility Information:
Facility Name
Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

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Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

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