Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

Conditions
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Asthma, Chronic Sinusitis

Intervention / Treatment
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* Procedure: Endoscopic Sinus Surgery
* Other: medical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Medical therapy<br>Patients undergo surgery 6 months after randomization | Other: medical therapy<br>* Subjects will undergo surgery 6 months after randomization<br>|
| Experimental: Surgery<br>Patients undergo surgery at time of randomization | Procedure: Endoscopic Sinus Surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Score |  |  |