Long-term Study, Comparing Vest Therapy to Positive Expiratory Pressure (PEP) Therapy in the Treatment of Cystic Fibrosis
|Cystic Fibrosis||Other: Positive Expiratory Pressure (PEP) Other: High Frequency Chest Wall Oscillation (HFCWO) using InCourage Vest System||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-centre, Long-term Comparative Trial of High Frequency Chest Wall Oscillation Versus Positive Expiratory Pressure Mask in the Treatment of Cystic Fibrosis|
- Difference in the number of respiratory exacerbations during the 1 year study period [ Time Frame: 1 year ]
- The time to the first respiratory exacerbation. Change in FEV1 measured as difference in the yearly mean rate of decline. Cost analysis between the two groups. Quality of life questionnaire. Patient satisfaction questionnaire and Adherence to treatment. [ Time Frame: 1 year ]
|Study Start Date:||October 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Active Comparator: A
Positive Expiratory Pressure (PEP) - an airway clearance technique
Other: Positive Expiratory Pressure (PEP)
Physiotherapy technique for airway clearance
Active Comparator: B
High Frequency Chest Wall Oscillation (HFCWO) also known as the 'Vest technique' - an airway clearance technique.
Other: High Frequency Chest Wall Oscillation (HFCWO) using InCourage Vest System
Physiotherapy technique for airway clearance.
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Objective This is a pilot study to evaluate the long-term clinical efficacy of high frequency chest wall oscillation (HFCWO) using the inCourage vest system, compared to positive expiratory pressure mask (PEP) in the treatment of patients with cystic fibrosis.
Study Design This is a one year prospective multi-centre randomized controlled trial of HFCWO versus PEP as airway clearance techniques in patients with cystic fibrosis. Number of respiratory exacerbations will be compared between the two treatment arms. Slope of percent predicted in FEV1, activity level, quality of life, cost analysis and subject satisfaction will also be compared.
Number of subjects Enrollment will be completed after 170 subjects have been recruited, approximately 85 in each arm.
Number of sites The study will involve between 14 CF centres in Canada.
PERSCRIBED AIRWAY CLEARANCE TECHNIQUE The test airway clearance technique is the
- High Frequency Chest Wall Oscillation using the InCourage Vest System. This will be compared to
- The Positive Expiratory Pressure Mask Technique. Subjects will be randomized to perform one of these techniques as their airway clearance technique for the period of the study.
PRIMARY ENDPOINT Primary: Difference in the number of respiratory exacerbations. (For definition see Appendix A). Defined by the presence of one major criteria or 2 minor signs or symptoms.
- Decrease in FEV1 of ≥10% from best baseline within past 6 months, unresponsive to ventolin.
- Oxygen saturation <90% on room air or ≥ 5% decline from previous baseline.
- New finding(s) on chest radiograph.
- Hemoptysis (more than streaks on more than one occasion in past week).
- Increased work of breathing or respiratory rate.
- New or increased adventitial sounds on lung exam.
- Weight loss ≥ 5% of body weight or decrease across one major percentile in weight percentile for age within the past 6 months.
- Increased cough.
- Decreased exercise tolerance or level of activity.
- Increased chest congestion or change in sputum.
For minor signs/symptoms, duration of symptoms need to be ≥ 5 days or significant symptom severity.
- The time to the first respiratory exacerbation will be measured in each group using the same definition of a respiratory exacerbation as used for the primary outcome.
- Change in FEV1 measured as difference in the yearly mean rate of decline (Appendix E).
- Cost analysis between the two groups.
- Quality of life questionnaire.
- Patient satisfaction questionnaire.
- Adherence to treatment.
DATA SAFETY MONITORING COMMITTEE
The study will be monitored by a Data Safety Monitoring committee (DSMC). The will communicate regularly either by teleconference, email or by face to face meetings, to deal with issues that arise. The will review all serious adverse events as they occur. The DSMC may request an analysis at any time. At the end of the randomized trial, a report of select final analyses will be provided the DSMC. The study may be terminated if the investigators, medical monitor, or DSMC have significant concerns about the safety of HFCWO based on serious adverse events, other safety data or the conduct of the trial.
STATISTICS Primary Analysis: The number of exacerbations during treatment will be determined in each arm and the difference between the groups calculated with 95% confidence limits as a measure of precision.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817180
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Alberta Children's Hospital|
|Edmonton, Alberta, Canada, T3B 2C8|
|University of Alberta Hospitals|
|Edmonton, Alberta, Canada, T6G 2B7|
|Canada, British Columbia|
|BC Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Children's Hospital of Winnipeg|
|Winnipeg, Manitoba, Canada, R3A 1S1|
|Canada, Newfoundland and Labrador|
|St. Clare's Mercy Hospital|
|St. John's, Newfoundland and Labrador, Canada, A1C 5B8|
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Ottawa General Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|The Hospital for Sick Children, Toronto|
|Toronto, Ontario, Canada|
|Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3H 1P3|
|Montreal, Quebec, Canada, H3T 1C5|
|Centre Mere-Enfant du CHUQ|
|Quebec, Canada, G1V 4G2|
|Principal Investigator:||Maggie McIlwaine, Physio||BC Children's Hospital, Vancouver|
|Study Director:||George Davidson, MD||BC Children's Hospital, Vancouver|
|Study Director:||Candice Bjornson, MD||Alberta Children's Hospital|
|Study Director:||Clare Smith, Physio||Alberta Children's Hospital|
|Study Director:||Hans Pasterkamp, MD||Children's Hospital of Winnipeg|
|Study Director:||Linda Kraemer, Physio||Children's Hospital of Winnipeg|
|Study Director:||Felix Ratjen, MD||The Hospital for Sick Children, Toronto|
|Study Director:||Jennifer Agnew, Physio||The Hospital for Sick Children, Toronto|
|Study Director:||Larry Lands, MD||Montreal Children's Hospital of the MUHC|
|Study Director:||Nancy Alarie, Physio||Montreal Children's Hospital of the MUHC|
|Study Director:||Pearce Wilcox, MD||St. Paul's Hospital, Vancouver|
|Study Director:||Brigette Wilkins, Physio||St. Paul's Hospital, Vancouver|
|Study Director:||Sherri Katz, MD||Children's Hospital of Eastern Ontario, Ottawa|
|Study Director:||Linda Lapointe, Physio||Children's Hospital of Eastern Ontario|
|Study Director:||Shawn Aaron, MD||The Ottawa Hospital|
|Study Director:||Lynne Orser, Physio||The Ottawa Hospital|
|Study Director:||Harvey Rabin, MD||Foothills Medical Centre, Calgary|
|Study Director:||Julie Wilson, Physio||Foothills Medical Centre, Calgary|
|Study Director:||Mary Noseworthy, MD||Janeway Children's Health & Rebab. Centre, St. John's|
|Study Director:||Stephanie Spencer, Physio||St. Clare's Mercy Hospital, St. John's|
|Study Director:||Peter Zuberbuhler, MD||University of Alberta Hospitals, Edmonton|
|Study Director:||Suzanne Bergsten, Physio||University of Alberta Hospitals, Edmonton|
|Study Director:||Neil Brown, MD||University of Alberta Hospitals, Edmonton|
|Study Director:||Joyce Sharum, Physio||University of Alberta Hospitals, Edmonton|
|Study Director:||Jacques-Edouard Marcotte, MD||CHU Ste-Justine, Montreal|
|Study Director:||Nadia Marquis, Physio||CHU Ste-Justine, Montreal|
|Study Director:||Patrick Daigneault, MD||CHUQ, Universite Laval, Quebec|
|Study Director:||Christine Bouchard, Physio||CHUL, Universite Laval, Quebec|