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| Name | Class |
|---|---|
| Tanabe Pharma America, Inc. | INDUSTRY |
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The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.
SVC is obtained with in-clinic conventional spirometry, in-clinic portable spirometry, and in-home portable spirometry with respiratory therapist-supervised remote pulmonary function testing every two weeks in a six month prospective study of participants with a diagnosis of Amyotrophic Lateral Sclerosis. SVC decline over time, seated and supine, will be tracked with assessments for treatment changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUNY Upstate | One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects. |
| |
| Atrium Health | One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirometry | Diagnostic Test | All study participants will undergo pulmonary function testing using conventional spirometry in clinic and portable spirometry in clinic and at home. In-clinic conventional laboratory spirometry is compared with portable spirometry and Slow vital capacity is obtained in upright and supine positions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR) | Minimum 0, Maximum 48; Lower scores worse | 2 week intervals for 6 months |
| Change from baseline SVC percent predicted at clinic | SVC measured at clinic in seated and supine positions using conventional and portable spirometer | 3 months |
| Change from baseline SVC percent predicted at clinic | SVC measured at clinic in seated and supine positions using conventional and portable spirometer | 6 months |
| Change from baseline SVC percent predicted at home | SVC measured from home in seated and supine positions using portable spirometer | 2 week intervals for 6 months |
| Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15) | Minimum 0, Maximum 30; Higher scores worse | 2 week intervals for 6 months |
| Change from baseline Hospital Anxiety and Depression Scale (HADS) | Minimum 0, Maximum 42; Higher scores worse | 6 months |
| Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months | Minimum 0, Maximum 20; Higher scores worse | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects are invited to volunteer and recruited from ALS specialty care outpatient clinics at SUNY Upstate and Atrium Health.
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| Name | Affiliation | Role |
|---|---|---|
| Eufrosina Young, MD | SUNY Upstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate | Syracuse | New York | 13210 | United States | ||
| Atrium Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957547 | Background | Geronimo A, Simmons Z. Evaluation of remote pulmonary function testing in motor neuron disease. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Aug;20(5-6):348-355. doi: 10.1080/21678421.2019.1587633. Epub 2019 Apr 7. | |
| 27598295 | Background | Hegewald MJ, Gallo HM, Wilson EL. Accuracy and Quality of Spirometry in Primary Care Offices. Ann Am Thorac Soc. 2016 Dec;13(12):2119-2124. doi: 10.1513/AnnalsATS.201605-418OC. |
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The plan is to share Individual Patient Data collected during the study to research team from both sites.
2 years.
Research team includes Principal investigators, sub-investigators, clinical research coordinators and respiratory therapists at each site, Pulmonologist Central Readers at SUNY Upstate. Deidentified data is shared with study sponsor MTPA.
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D013147 | Spirometry |
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
|
| Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS) |
Minimum 0, Maximum 20; Lower scores worse |
| 6 months |
| Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS) ALS Caregiver Behavioral Questionnaire at 6 months | Minimum 0, Maximum 45; Lower scores worse | 6 months |
| Change from baseline Amyotrophic Lateral Sclerosis Treatment Questionnaire | Reports usage of non-invasive ventilation, gastrostomy tube, ALS medications and ALS devices | 2 week intervals for 6 months |
| Charlotte |
| North Carolina |
| 28211 |
| United States |
| 16319028 | Background | Couratier P, Vincent F, Torny F, Lacoste M, Melloni B, Lemaire F, Antonini MT. Spirometer-dependence of vital capacity in ALS: validation of a portable device in 52 patients. Amyotroph Lateral Scler Other Motor Neuron Disord. 2005 Dec;6(4):239-45. doi: 10.1080/14660820510043244. |
| 20650985 | Background | Masa JF, Gonzalez MT, Pereira R, Mota M, Riesco JA, Corral J, Zamorano J, Rubio M, Teran J, Farre R. Validity of spirometry performed online. Eur Respir J. 2011 Apr;37(4):911-8. doi: 10.1183/09031936.00011510. Epub 2010 Jul 22. |
| 31613151 | Background | Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. |
| 30486680 | Result | Rutkove SB, Qi K, Shelton K, Liss J, Berisha V, Shefner JM. ALS longitudinal studies with frequent data collection at home: study design and baseline data. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Feb;20(1-2):61-67. doi: 10.1080/21678421.2018.1541095. Epub 2018 Nov 28. |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |