Standardized Home Spirometry Method in Normal Population

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.

Study Objective: This study was designed to evaluate the feasibility of use of a Standardized Home Spirometry(SHS) Method using a Home Spirometry Monitoring Kit consisting of FDA-approved Blue-tooth Spirometry unit, Blue-tooth pulse oximeter and an Android-based Tablet with an embedded investigational home spirometry mobile medical software application for data and symptom survey collection and transmission over secure WiFi or cellular data transmission portal in HIPAA compliant fashion to an associated investigational IT dashboard application at the Central Monitoring Institute (CMI) Server at Washington University in St. Louis, 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 to the CMI in a small pilot of healthy volunteers prior to evaluation and use on a larger scale for lung transplant recipients.

The investigational IT application will monitor lung function but do nothing more than collect data. It will adjust monitoring frequency and trigger physician review of home spirometry results at a more frequent interval but will not be directly involved in decisions regarding diagnosis or treatment.

Study Type: Non-randomized, single-arm, prospective cohort study

Intervention:

* The Home Spirometry Monitoring System will consist of:

  * FDA approved Blue tooth Spirometry unit
  * FDA approved pulse oximeter
  * An Android-based tablet with embedded investigational mobile medical software application for symptom survey/data collection and data processing and transmission
* WiFi or cellular connectivity to be used for data transmission and communication between an Android Pad and an associated Investigational server dashboard application at the Central Monitoring Institute
* Normal Volunteer Monitoring Data is sent in a HIPAA compliant fashion (data with date/time stamp and device ID only) to a Central Monitoring Institute (CMI) server maintained at Washington University in St. Louis
* Participants will undergo training to activate and use the Home Spirometry Monitoring System.
* Data evaluation by a pulmonologist within CMI:

  * Trend analysis on a monthly basis and
  * When a variance is detected with or without potentially associated symptoms.
  * A monthly summary report
* Participants may undergo one Laboratory-based Spirometry Test (if practicable) and perform a test session using the standardized home spirometry method system at baseline.
* Participation may last up to one year.

Standardized Home Spirometry testing interval at least weekly with an initial testing period of greater frequency to enable normal range calibration. Volunteers will require initial in center or remote training with the Standardized home spirometry method \& performance of baseline home spirometry method testing and a (baseline) laboratory-based spirometry test (if practicable).

Pre-Surveillance Phase: Daily home spirometry method measurements for 4 to 10 weeks to enable normal range calibration. Volunteers who have either a statistically significant (p-value \<0.01) rate of change in FEV1 or a change in FEV1 rate of decline that exceeds an absolute value (+/-) of 30 mL/month using home spirometry based FEV1 values obtained during the normal range development period are not eligible to advance to the Surveillance Phase and may be discontinued from the study.

Surveillance Phase: At least weekly home spirometry method measurements for two to ten months of participation. An FEV-1 (Forced Expiratory Volume in one second) variance is defined as an FEV-1 value that is outside the 95% CI (Confidence Interval) of the participant's normal FEV-1 reference range that was determined immediately after enrollment.

If an FEV-1 variance is detected by the Android Pad, the IT application automatically requests that the participant complete a symptom survey. This information when used in combination with other data will result in initiation of the following actions:

If an FEV-1 variance is categorized as being suspicious for acute medical illness by the CMI (i.e., with clinical symptoms consistent with upper or lower respiratory infection/CHF), the spirometry data and participant survey responses will trigger overview by the CMI laboratory staff and if deemed suspicious for acute medical illness results will be made accessible to the participant's designated health professionals. If critical values or clinical symptoms are obtained consistent with urgent compromise (e.g., evidence of hypoxemia or respiratory distress), the CMI (PFT (Pulmonary Function Testing) Laboratory staff pulmonologist) will make timely attempts to reach the participant or participant's health professionals. In this study, this is expected to be an exceedingly rare occurrence, and most likely would not occur at all. If acute medical illness has been ruled in, participant spirometry surveillance will be reinitiated after an appropriate period of treatment, which will be determined by the participant's managing physician who will notify CMI when the participant has recovered from their acute illness.

Variance not suspicious for acute medical illness with no apparent clinical symptoms consistent with infection/CHF: if supplemental questionnaire or clinical data is not consistent with an acute medical illness, the following actions will be taken:

Persistence Evaluation: Participants will be directed to obtain daily spirometric measurements along with repeated completion of the questionnaire for a total of 4 consecutive days CMI Pulmonology Review: Consistently low Spirometry values (persistence) will prompt early review of these values along with previous Spirometry history by CMI pulmonology staff.

Random Symptom Surveys may also generate (in the absence of a variance) however only Symptom Surveys prompted by Variances will result in further action as described above.

During the first two months (approximately) of Surveillance, Volunteers will be directed to intentionally induce variances, symptoms, incomplete connections/testing/survey, etc., in order to fully test and assess the functionality of the Mobile Medical Software neural pathways (IT app and Dashboard server) as directed by the study team. Volunteers will document test on a test log.

The FDA issued a non-significant risk (NSR) device study letter on 12/3/2018 for the Home Spirometry Mobile Medical Software.

Eligibility Criteria:
Inclusion Criteria:

1. Age (18 years old or older)
2. 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.

Exclusion Criteria:

1. 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.
2. Any condition that would significantly affect the participant's ability to adhere to the protocol, or affect interpretation of the study results.
3. 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.)
4. 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)
5. Concomitant participation in another trial with an investigational device or investigational drug