Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population

E

Electromed

Status

Completed

Conditions

Bronchiectasis

Treatments

Device: SmartVest Airway Clearance System

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04271969
HFCWO-001

Details and patient eligibility

About

The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use.

Full description

This study will use a prospective interventional comparative study design using the patient's quality of life (QoL) as the primary study endpoint to determine HFCWO affect. The study will compare the patient's QoL baseline (established at enrollment prior to HFCWO treatment) to the QoL measured at various timepoints (enrollment, 2 months, 6 months and 12 months) over a one-year period whilst receiving HFCWO treatment. In addition, a baseline for the secondary endpoints will established at enrollment for comparison to measurements taken at various timepoints over a one-year period whilst receiving HFCWO treatment. The patient's medical records will be used to establish prior histories of exacerbation rates for comparison to exacerbation rates experienced after one year of HFCWO treatment. Patients will serve as their own control.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. 18 years of age or older
  2. Previous diagnosis of bronchiectasis confirmed by HRCT within the last 6 months
  3. Patients must have at least 6 months of medical records related to bronchiectasis
  4. Patients must be stable and currently on a standard of care regimen for bronchiectasis such as hypertonic saline and/or PEP
  5. Patients with 1 or more exacerbations within the last 12 months
  6. Previous and existing productive cough
  7. No previous HFCWO use

Exclusion criteria

  1. Patients who are known to have cystic fibrosis
  2. Patients who are known to have primary ciliary dyskinesia (PCD)
  3. Patients with chronic obstructive pulmonary disease (COPD) without bronchiectasis
  4. Patients breathing via an artificial airway
  5. Severe bronchospasm based on exam or history
  6. Any comorbidity(ies) or contraindications that would normally complicate tolerating HFCWO treatment

Trial contacts and locations

4

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Central trial contact

Chet Sievert

Data sourced from clinicaltrials.gov

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