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| ID | Type | Description | Link |
|---|---|---|---|
| 144QK18 |
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| Name | Class |
|---|---|
| Syntara | INDUSTRY |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is an ancillary study conducted as part of the BASALT trial [NCT00495157].
The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can safely characterize asthma phenotypes, predict asthma control and exacerbations, predict responses to interventions, and perform more specifically than a direct methacholine challenge and; 2) PX27 pore function in whole blood correlates with measures of airway hyperresponsiveness induced by methacholine and/or mannitol challenges
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exploratory Mannitol | Experimental | This is an exploratory / ancillary study open to all participants in the BASALT trial [NCT00495157] who consented to undergo mannitol bronchoprovocation procedures during the 36 week treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mannitol | Drug | indirect mannitol challenge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine (conducted as part of the main BASALT trial). | At 6 weeks, 20 weeks, and 32 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the baseline PD15FEV1 with other baseline physiologic measurements collected in the BASALT trial | To evaluate the applicability of mannitol bronchoprovocation to characterize the asthma phenotype. Correlation of the baseline PD15FEV1 with other baseline physiologic measurements and methacholine bronchoprovocation performance as collected in the BASALT trial. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine A Sorkness, Pharm.D. | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22968888 | Background | Calhoun WJ, Ameredes BT, King TS, Icitovic N, Bleecker ER, Castro M, Cherniack RM, Chinchilli VM, Craig T, Denlinger L, DiMango EA, Engle LL, Fahy JV, Grant JA, Israel E, Jarjour N, Kazani SD, Kraft M, Kunselman SJ, Lazarus SC, Lemanske RF, Lugogo N, Martin RJ, Meyers DA, Moore WC, Pascual R, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Walter MJ, Wechsler ME, Boushey HA; Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial. JAMA. 2012 Sep 12;308(10):987-97. doi: 10.1001/2012.jama.10893. |
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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 |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |