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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical therapy | Placebo Comparator | Patients undergo surgery 6 months after randomization |
|
| Surgery | Experimental | Patients undergo surgery at time of randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Sinus Surgery | Procedure |
| ||
| medical therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Score |
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Inclusion Criteria:
Inclusion criteria: General
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evanston Hospital | Evanston | Illinois | 60201 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Subjects will undergo surgery 6 months after randomization |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |