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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3HL173394-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study will examine the ability of steroid injections into the site of stenosis following surgical dilation to delay the need for repeated surgical dilations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional steroid injection with Triamcinolone | Experimental |
| |
| Intralesional Placebo injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone 0.1% | Drug | Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Expiratory Flow (Liters/min) | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical COPD Questionnaire | Score range 0-60, Lower score indicates better health | 6 months |
| Voice Handicap Index-10 | Score range 0 to 40, Lower score indicates better voice |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Hillel, M.D. | Contact | 4432876006 | ahillel@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Hillel, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21231 | United States |
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| ID | Term |
|---|---|
| C536283 | Idiopathic subglottic tracheal stenosis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Intralesional Placebo injection 3x at one, two, and three months following surgical dilation |
|
| 6 Months |