Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

Stopped early · Not applicable

Conditions studied: Asthma, Chronic Sinusitis

In brief

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.

Key facts

Study ID

NCT01066416

Run by

Endeavor Health

People needed

1

Starts

2009-07-01

Expected to finish

2010-12-01

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Evanston Hospital — Evanston, Illinois, United States

Full record on ClinicalTrials.gov

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