Comparison of Airway Clearance Therapy in Cystic Fibrosis Using the Same VEST Therapy Device But With Different Settings

NCT00685035 | Completed Phase 4 Results DMC

• 1 other identifier: 0802M26441
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine waveform HFCWO with lower inflation pressures and mid-frequency oscillations.

Conditions

Cystic Fibrosis

Keywords

high frequency chest wall oscillation, cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• Sputum Wet and Dry Weight

  All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum "wet weight" was calculated after re-weighing the container with the sputum pellet. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum "dry weight" was calculated after re-weighing the container.

  Produced during each airway clearance therapy session on days 1 and 4

Secondary Outcomes (3)

• Pre vs. Post Therapy Spirometry

  Prior to and following each airway clearance therapy session on days 1 and 4

• Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session

  Sputum produced during the 15 minutes immediately following airway clearance therapy sessions on day 1 and day 4

• Patients' Perceived Comfort Using the Different Settings for the Vest Device

  Immediately following each airway clearance therapy on day 1 and day 4

Study Arms (2)

HFCWC with higher pressure/variable frequency settings

ACTIVE COMPARATOR

Half patients randomly assigned to perform HFCWC therapy first with a higher pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period

Device: HFCWC with higher pressure/variable-frequency settings; Device: HFCWC with lower pressure/mid-frequency settings

HFCWC with lower pressure/mid-frequency settings

ACTIVE COMPARATOR

lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency

Device: HFCWC with higher pressure/variable-frequency settings; Device: HFCWC with lower pressure/mid-frequency settings

Interventions

HFCWC with higher pressure/variable-frequency settings DEVICE

Randomized crossover trial of airway clearance therapy comparing sine wave HFCWO with high pressures and variable frequency (pressure 10, frequencies 8,9,10 and pressure 6, frequencies 18,19,20) to low pressure and mid frequency (pressure 5, frequency 12). Subjects will have 2-day washout between airway clearance sessions. All sputum collected during sessions.

Also known as: High frequency chest wall oscillation

HFCWC with higher pressure/variable frequency settings; HFCWC with lower pressure/mid-frequency settings

HFCWC with lower pressure/mid-frequency settings DEVICE

Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects will complete a questionnaire addressing the comfort of therapy upon completion of the session.

Also known as: high frequency chest wall oscillation

HFCWC with higher pressure/variable frequency settings; HFCWC with lower pressure/mid-frequency settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CF established by sweat chloride \> 60 mmol/L.
• Age older than 18 years.
• History of chronic daily sputum production.
• Currently on a home therapeutic regimen that includes some form of airway clearance performed with a HFCWO device at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
• FVC and FEV1 \> 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).
• Evaluated at the University of Minnesota CF Center 3 or more times in the preceding 12 months.

You may not qualify if:

• Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
• Hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment.
• Chest pain requiring use of narcotic for pain control.
• Current participation in another clinical trial.
• Use of intravenous antibiotics for CF respiratory complications in the 2 months preceding enrollment.
• No prior experience using HFCWO devices for airway clearance

Sponsors & Collaborators

• University of Minnesota: lead
• Hill-Rom: collaborator

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Kempainen RR, Milla C, Dunitz J, Savik K, Hazelwood A, Williams C, Rubin BK, Billings JL. Comparison of settings used for high-frequency chest-wall compression in cystic fibrosis. Respir Care. 2010 Jun;55(6):695-701.

  PMID: 20507651 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Limitations and Caveats

1. Sputum weights varied more than anticipated and the study was underpowered to detect differences in the primary outcomes. 2. Study not generalizable to patients that do not produce sputum or have an FEV1 \< 40% predicted.

Results Point of Contact

• Title: Dr. Robert Kempainen
• Organization: University of Minnesota School of Medicine

kempa001@umn.edu

612-873-6413

Study Officials

• Robert R Kempainen, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 28, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-06

Locations

US (1)