Cystic Fibrosis Clinical Trial
Official title:
A Pilot Study to Evaluate the Use of the MN4000 for Treatment of Cystic Fibrosis (CF) and Motor Neuron Disease (MND) Patients in the Home Setting
Verified date | January 2019 |
Source | Hill-Rom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study was a non-randomized open label pilot study. It was an observational design
conducted at one (1) site in the US. All enrolled subjects received treatment with the
MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy
during the 90-day treatment period, and also collected clinical outcome data. Outcomes were
assessed before, during and after the MN4000 treatment period.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 30, 2017 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Documented diagnosis of CF or MND - Age > 18 years - Signed informed consent Exclusion Criteria: - Requirement for continuous mechanical ventilation - Anticipated requirement for hospitalization within the next three months - History of pneumothorax within past 6 months - History of hemoptysis requiring embolization within past 12 months - Inability to perform MN4000 therapy using a mouthpiece (e.g. inability to create adequate mouth seal) - Inability to perform MN4000 therapy as directed - Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Hill-Rom |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient / Caregiver Satisfaction scores | The primary efficacy variable was patient and/or caregiver satisfaction with therapy, as evaluated using a Therapy Use Rating Scale questionnaire. The Therapy Use Rating Scale is an assessment of patient/caregiver satisfaction with the therapy and their subjective assessment of the benefit of the therapy. This was assessed by a 5 point likert scale assessing effectiveness, ease of use and likelihood to continue therapy with 5 representing positive responses and 1, negative. | 90 days | |
Secondary | Mean adherence to prescribed treatment regimen | Evidenced by feedback on adherence to therapy. Use of the MN4000 was evaluated, collecting daily treatment usage information from study subjects and/or caregivers to determine the level of adherence to the prescribed therapy regimen. A self reporting tool has been developed for the study assessing adherence to duration of individual prescribed treatment time and overall study duration. | 90 days | |
Secondary | ALS-Functional Rating Scale (ALS-FRS) | MND patients only. MND patients only. The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is an instrument for evaluating the functional status of patients with Amyotrophic Lateral Sclerosis. It can be used to monitor functional change in a patient over time. It contains 10 distinct measures: Speech Salivation Swallowing Handwriting Cutting food and handling utensils (with or without gastrostomy) Dressing and hygiene turning in bed and adjusting bed clothes Walking Breathing Climbing stairs These 10 parameters are scored on a scale of 0-4, based on the patients' ability to perform tasks. The minimum score is 0 and maximum 40.The higher the score the more function is retained. |
90 days | |
Secondary | Cystic Fibrosis Questionnaire - Revised (CFQ-R) | CF patients only. The Cystic Fibrosis Questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF) > or = 14 years, consisting of 44 items on 12 generic and disease-specific scales. It offers 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never). Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. | 90 days | |
Secondary | Exacerbation of pulmonary disease | Hospitalization and/or antibiotics for respiratory infection or complication. Exacerbations of pulmonary disease were defined as respiratory infections that resulted in requirement for hospitalization and/or antibiotics to treat the respiratory infection or complication. Hospitalizations that are part of routine care (e.g. hospital admissions for annual "tune-up") or antibiotics that are part of the regular treatment regimen were not documented as exacerbations. Occurence of exarcerbation related hospitalization OR the necessity of a prescription for antibiotics qualify as worsening disease. | 90 days | |
Secondary | FEV1 | FEV1: The forced expiratory volume-one second is the total volume of air a patient exhales in the first second during maximal effort. Normal range is >80%. Decreasing percentage is associated with worsening / Severe disease | 90 days | |
Secondary | FVC | The functional vital capacity is the total volume of air a patient exhales for the total duration of the test during maximal effort. Normal range is >80%. Decreasing percentage is associated with worsening / Severe disease | 90 days | |
Secondary | FEV1/FVC ratio | The percentage of the FVC expired in one second Results are given in both raw data (litres, litres per second) and % predicted—the test result as a percent of the "predicted values" for the patients of similar characteristics. Results over 80% are considered normal. | 90 days | |
Secondary | SVC | Slow Vital Capacity displays the volume of gas measured on a complete expiration after a maximal inspiration without forced or rapid effort. Useful measurement when FVC is reduced and airway obstruction is present. educed SVC is associated with worsening respiratory disease | 90 days | |
Secondary | SPO2 | SpO2 stands for peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. Low SPO2 is associated with worsening respiratory function. | 90 days | |
Secondary | Maximal inspiratory pressure (MIP) | Maximal inspiratory pressure (MIP) is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. Reduction in MIP is asociated with worsening neuromuscular status and poor ability to cough. | 90 days | |
Secondary | PCF | The Peak Cough Flow is the maximum air flow generated during a cough. Decreasing air flow generated is associated with weakening neuromuscular status and associated poor cough impulse | 90 days |
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