Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control



Status:Completed
Conditions:Asthma, Sinusitis
Therapuetic Areas:Otolaryngology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:July 2009
End Date:December 2015
Contact:stacy m raviv, MD
Email:stacyraviv@gmail.com
Phone:3124209444

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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.


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
We found this trial at
1
site
2650 Ridge Ave.
Evanston, Illinois 60201
847.570.2000
Evanston Hospital Evanston Hospital, opened in 1891, is the nucleus of the NorthShore University HealthSystem....
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mi
from
Evanston, IL
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