Long-term Study, Comparing Vest Therapy to Positive Expiratory Pressure (PEP) Therapy in the Treatment of Cystic Fibrosis
Multi-centre, Long-term Comparative Trial of High Frequency Chest Wall Oscillation Versus Positive Expiratory Pressure Mask in the Treatment of Cystic Fibrosis
2 other identifiers
interventional
107
1 country
13
Brief Summary
This study is a preliminary study designed to determine the safety and effectiveness of HFCWO using the InCourage vest system as an airway clearance technique for the treatment of CF. The study will compare HFCWO to the most commonly used airway clearance technique in Canada, namely the Positive Expiratory Pressure technique in patients with CF over a period of one year. As this is a preliminary study, it will not be able to determine if the vest is equivelant to PEP, but will provide the information needed to plan a larger study to answer that question.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 2, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMarch 17, 2014
March 1, 2014
3.5 years
January 2, 2009
March 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in the number of respiratory exacerbations during the 1 year study period
1 year
Secondary Outcomes (1)
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.
1 year
Study Arms (2)
A
ACTIVE COMPARATORPositive Expiratory Pressure (PEP) - an airway clearance technique
B
ACTIVE COMPARATORHigh Frequency Chest Wall Oscillation (HFCWO) also known as the 'Vest technique' - an airway clearance technique.
Interventions
Physiotherapy technique for airway clearance.
Eligibility Criteria
You may qualify if:
- Male or female 6 years of age or older at enrollment and be competent in performing spirometry.
- Confirmed diagnosis of CF.
- FEV1\> 45% predicted as calculated by Wang reference equations
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Clinically stable at enrollment with no evidence of respiratory exacerbation within a month of enrollment as assessed by the site CF Physician.
- Willingness to adhere to prescribed treatment regimen.
You may not qualify if:
- Diagnosis of Allergic Broncho-Pulmonary Aspergillosis, or a persistent culture for B.cepacia complex within the previous 1 year period
- On active treatment for non Tuberculous Mycobacterium.
- Use of intravenous antibiotics within the previous 14 days of enrollment.
- Initiation and or change in maintenance therapy within 14 days of enrollment.
- Use of systemic corticosteriods (1mg/kg if \< 20 kg or 20 mg of prednisone per day) within 14 days of enrollment.
- Concurrent participation in another study that could potentially affect the present study.
- Haemoptysis of over 20 mls on more than 2 occasions within the previous 30 days from enrollment.
- A pneumothorax in the six months preceding the study.
- Presence of a condition or abnormality that in the opinion of the site CF Physician would compromise the safety of the patient or the quality of the data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Alberta Children's Hospital
Edmonton, Alberta, T3B 2C8, Canada
University of Alberta Hospitals
Edmonton, Alberta, T6G 2B7, Canada
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Children's Hospital of Winnipeg
Winnipeg, Manitoba, R3A 1S1, Canada
St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6, Canada
The Hospital for Sick Children, Toronto
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3, Canada
CHU Ste-Justine
Montreal, Quebec, H3T 1C5, Canada
Centre Mere-Enfant du CHUQ
Québec, Quebec, G1V 4G2, Canada
Related Publications (1)
McIlwaine MP, Alarie N, Davidson GF, Lands LC, Ratjen F, Milner R, Owen B, Agnew JL. Long-term multicentre randomised controlled study of high frequency chest wall oscillation versus positive expiratory pressure mask in cystic fibrosis. Thorax. 2013 Aug;68(8):746-51. doi: 10.1136/thoraxjnl-2012-202915. Epub 2013 Feb 13.
PMID: 23407019DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2009
First Posted
January 6, 2009
Study Start
October 1, 2008
Primary Completion
April 1, 2012
Study Completion
July 1, 2012
Last Updated
March 17, 2014
Record last verified: 2014-03