Standardized Home Spirometry Method in Normal Population

NCT03945500 | Completed

• 1 other identifier: 201806011
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the feasibility of using a Standardized Home Spirometry (SHS) Method to develop normal range values, to detect a variance (i.e., a value outside of that normal range), to evaluate a variance with a questionnaire, and to download all data in normal volunteers prior to evaluation and use on a larger scale for lung transplant recipients. The Standardized Home Spirometry (SHS) Method consists of a FDA-approved Bluetooth Spirometry unit, FDA approved Bluetooth Pulse Oximeter and an Android-based Tablet which is embedded with an investigational Home Spirometry Mobile Medical Software Application for data and symptom survey collection and transmission over secure WiFi or cellular connectivity in HIPAA compliant fashion (labeled only with a date/time and machine ID stamp) to an associated investigational IT Server Dashboard at the Central Monitoring Institute Server at Washington University in St. Louis.

Conditions

Mobile Applications; Healthy Volunteers; Feasibility Study

Outcome Measures

Primary Outcomes (3)

• Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Assess Home Spirometry reproducibility during pre-surveillance period.

  Evaluate daily FEV1 variability between replicate measurements by summarizing between measurement %difference; Evaluate between day variability in highest FEV1 (FEV1 Max) variability by summarizing %Difference from FEV1 Max values and two SD (Standard Deviation) Coefficient of Variation (expected to be less than 30%) between FEV1 measurements during pre-surveillance period.

  Up to 8 weeks

• Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Drift Assessment

  Evaluate the functionality of the investigational Mobile Medical Software Application and associated IT Server Dashboard for statistically significant drift in relationship between %FEV1 Max or mean FEV1 Max over time and subsequent transition to Surveillance monitoring stage.

  Up to 8 weeks

• Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Pathway Verification

  Evaluate the Mobile medical application software and associated IT server data processing pathways using % initial error rate (initial error rate and subsequent error rate, after any potential adjustments are made in mobile medical application if changes are required).

  Through study completion, up to 10 months

Study Arms (1)

Standardized Home Spirometry (SHS) Method

EXPERIMENTAL

The Standardized Home Spirometry (SHS) Method consists of an Investigational Mobile Medical Application embedded in an Android Tablet \& FDA approved spirometer \& pulse oximeter. Participants will be trained with the SHS method, perform an initial home spirometry test session \& a lab-based spirometry test (if practicable). Pre-surveillance Phase:Daily SHS Testing for 4 to 10 weeks to enable the Mobile Medical application to generate volunteer specific normal range. Surveillance Phase: At least weekly SHS Testing. During approximately two months of the surveillance phase, the volunteer will test one to four times per week to assess the SHS neural pathways as directed by the study team. Test sessions will be documented on a test log. Subjects may be asked to perform additional SHS pathway test logs, continue at least weekly testing, pause testing or end participation following completion of the initial SHS neural pathway test log.

Device: Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter

Interventions

Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter DEVICE

Standardized Home Spirometry (SHS) Method consists of an Investigational Mobile Medical Application embedded into an Android Tablet, an FDA approved Bluetooth spirometer, an FDA approved pulse oximeter. HIPAA compliant data will be sent to an Investigational IT dashboard maintained at the Central Monitoring Institute Server. Volunteers will train in-center or remotely \& perform baseline testing with the SHS method along with a baseline laboratory-based spirometry test (if practicable). Pre-Surveillance Phase: Daily home spirometry method testing for 4 to 10 weeks to enable normal range calibration. Surveillance Phase: At least weekly home spirometry method testing for 2-10 months of participation. Volunteers will maintain a test log during study team directed SHS software pathway functionality testing.

Also known as: Baseline Laboratory Spirometry Testing

Standardized Home Spirometry (SHS) Method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age (18 years old or older)
• Volunteers who provide written informed consent to participate in this study and who are willing and able to perform frequent home spirometry monitoring and laboratory-based spirometry if practicable, per protocol.

You may not qualify if:

• Known cardiac, pulmonary or other condition, that may interfere with the subject's ability to perform lab-based pulmonary function testing or standardized home spirometry.
• Any condition that would significantly affect the participant's ability to adhere to the protocol, or affect interpretation of the study results.
• Pregnant or planning to become pregnant during the study. Pregnant volunteers are excluded as changes in spirometry associated with a gravid uterus could alter outcome data. (Volunteers should take measures to prevent pregnancy while participating in the study.)
• Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance, lack of WiFi and/or cellular access or inadequate English literacy/comprehension to operate the Home Spirometry System)
• Concomitant participation in another trial with an investigational device or investigational drug

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Mallinckrodt: collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (14)

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  PMID: 25242125 BACKGROUND

• Meyer KC, Raghu G, Verleden GM, Corris PA, Aurora P, Wilson KC, Brozek J, Glanville AR; ISHLT/ATS/ERS BOS Task Force Committee; ISHLT/ATS/ERS BOS Task Force Committee. An international ISHLT/ATS/ERS clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Eur Respir J. 2014 Dec;44(6):1479-503. doi: 10.1183/09031936.00107514. Epub 2014 Oct 30.

  PMID: 25359357 BACKGROUND

• Kapila A, Baz MA, Valentine VG, Bhorade SM; AIRSAC investigators. Reliability of diagnostic criteria for bronchiolitis obliterans syndrome after lung transplantation: a survey. J Heart Lung Transplant. 2015 Jan;34(1):65-74. doi: 10.1016/j.healun.2014.09.029. Epub 2014 Oct 7.

  PMID: 25447585 BACKGROUND

• Slovis BS, Loyd JE, King LE Jr. Photopheresis for chronic rejection of lung allografts. N Engl J Med. 1995 Apr 6;332(14):962. doi: 10.1056/NEJM199504063321417. No abstract available.

  PMID: 7877665 BACKGROUND

• O'Hagan AR, Stillwell PC, Arroliga A, Koo A. Photopheresis in the treatment of refractory bronchiolitis obliterans complicating lung transplantation. Chest. 1999 May;115(5):1459-62. doi: 10.1378/chest.115.5.1459.

  PMID: 10334173 BACKGROUND

• Salerno CT, Park SJ, Kreykes NS, Kulick DM, Savik K, Hertz MI, Bolman RM 3rd. Adjuvant treatment of refractory lung transplant rejection with extracorporeal photopheresis. J Thorac Cardiovasc Surg. 1999 Jun;117(6):1063-9. doi: 10.1016/s0022-5223(99)70241-2.

  PMID: 10343253 BACKGROUND

• Villanueva J, Bhorade SM, Robinson JA, Husain AN, Garrity ER Jr. Extracorporeal photopheresis for the treatment of lung allograft rejection. Ann Transplant. 2000;5(3):44-7.

  PMID: 11233043 BACKGROUND

• Benden C, Speich R, Hofbauer GF, Irani S, Eich-Wanger C, Russi EW, Weder W, Boehler A. Extracorporeal photopheresis after lung transplantation: a 10-year single-center experience. Transplantation. 2008 Dec 15;86(11):1625-7. doi: 10.1097/TP.0b013e31818bc024.

  PMID: 19077900 BACKGROUND

• Morrell MR, Despotis GJ, Lublin DM, Patterson GA, Trulock EP, Hachem RR. The efficacy of photopheresis for bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2010 Apr;29(4):424-31. doi: 10.1016/j.healun.2009.08.029. Epub 2009 Oct 22.

  PMID: 19853479 BACKGROUND

• Jaksch P, Scheed A, Keplinger M, Ernst MB, Dani T, Just U, Nahavandi H, Klepetko W, Knobler R. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012 Sep;31(9):950-7. doi: 10.1016/j.healun.2012.05.002.

  PMID: 22884382 BACKGROUND

• Greer M, Dierich M, De Wall C, Suhling H, Rademacher J, Welte T, Haverich A, Warnecke G, Ivanyi P, Buchholz S, Gottlieb J, Fuehner T. Phenotyping established chronic lung allograft dysfunction predicts extracorporeal photopheresis response in lung transplant patients. Am J Transplant. 2013 Apr;13(4):911-918. doi: 10.1111/ajt.12155. Epub 2013 Feb 13.

  PMID: 23406373 BACKGROUND

• Del Fante C, Scudeller L, Oggionni T, Viarengo G, Cemmi F, Morosini M, Cascina A, Meloni F, Perotti C. Long-Term Off-Line Extracorporeal Photochemotherapy in Patients with Chronic Lung Allograft Rejection Not Responsive to Conventional Treatment: A 10-Year Single-Centre Analysis. Respiration. 2015;90(2):118-28. doi: 10.1159/000431382. Epub 2015 Jun 20.

  PMID: 26112178 BACKGROUND

• Liistro G, Vanwelde C, Vincken W, Vandevoorde J, Verleden G, Buffels J; COPD Advisory Board. Technical and functional assessment of 10 office spirometers: A multicenter comparative study. Chest. 2006 Sep;130(3):657-65. doi: 10.1378/chest.130.3.657.

  PMID: 16963659 BACKGROUND

• Lefebvre Q, Vandergoten T, Derom E, Marchandise E, Liistro G. Testing spirometers: are the standard curves of the american thoracic society sufficient? Respir Care. 2014 Dec;59(12):1895-904. doi: 10.4187/respcare.02918. Epub 2014 Sep 2.

  PMID: 25185146 BACKGROUND

Study Officials

• George Despotis, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluate the feasibility of using a Standardized Home Spirometry Method and associated investigational Home Spirometry Mobile Medical Software (IT App) and Server "Dashboard" in a healthy volunteer population before beginning a separate full clinical trial in the lung transplant population. Feasibility of using the Standardized Home Spirometry Method and associated Home Spirometry Mobile Medical Software (IT App and Server "Dashboard" to develop normal range values, to detect a value outside of the normal range, to evaluate a value outside of the normal range with a symptom survey and to download all data to a Central Monitoring Institute will be evaluated.

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 10, 2019
• Study Start: January 20, 2021
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)