Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

NorthShore University HealthSystem1 site in 1 country1 target enrollmentJuly 2009

ConditionsAsthma Chronic Sinusitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: NorthShore University HealthSystem
Enrollment: 1
Locations: 1
Primary Endpoint: Asthma Control Score
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

December 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NorthShore University HealthSystem

Responsible Party

Sponsor

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).
•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

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