Long-term Study, Comparing Vest Therapy to Positive Expiratory Pressure (PEP) Therapy in the Treatment of Cystic Fibrosis
Launched by UNIVERSITY OF BRITISH COLUMBIA · Jan 5, 2009
Trial Information
Current as of May 30, 2025
Completed
Keywords
ClinConnect Summary
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 analys...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About University Of British Columbia
The University of British Columbia (UBC) is a leading research institution located in Vancouver, Canada, renowned for its commitment to advancing health sciences through innovative research and education. As a prominent clinical trial sponsor, UBC leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes across various medical fields. The university fosters collaborations with healthcare professionals, industry partners, and community stakeholders to translate research findings into practical applications, thereby contributing to the global advancement of medicine and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Ottawa, Ontario, Canada
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
St. John's, Newfoundland And Labrador, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Quebec, , Canada
Patients applied
Trial Officials
Maggie McIlwaine, Physio
Principal Investigator
BC Children's Hospital, Vancouver
George Davidson, MD
Study Director
BC Children's Hospital, Vancouver
Candice Bjornson, MD
Study Director
Alberta Children's Hospital
Clare Smith, Physio
Study Director
Alberta Children's Hospital
Hans Pasterkamp, MD
Study Director
Children's Hospital of Winnipeg
Linda Kraemer, Physio
Study Director
Children's Hospital of Winnipeg
Felix Ratjen, MD
Study Director
The Hospital for Sick Children, Toronto
Jennifer Agnew, Physio
Study Director
The Hospital for Sick Children, Toronto
Larry Lands, MD
Study Director
Montreal Children's Hospital of the MUHC
Nancy Alarie, Physio
Study Director
Montreal Children's Hospital of the MUHC
Pearce Wilcox, MD
Study Director
St. Paul's Hospital, Vancouver
Brigette Wilkins, Physio
Study Director
St. Paul's Hospital, Vancouver
Sherri Katz, MD
Study Director
Children's Hospital of Eastern Ontario, Ottawa
Linda Lapointe, Physio
Study Director
Children's Hospital of Eastern Ontario
Shawn Aaron, MD
Study Director
The Ottawa Hospital
Lynne Orser, Physio
Study Director
The Ottawa Hospital
Harvey Rabin, MD
Study Director
Foothills Medical Centre, Calgary
Julie Wilson, Physio
Study Director
Foothills Medical Centre, Calgary
Mary Noseworthy, MD
Study Director
Janeway Children's Health & Rebab. Centre, St. John's
Stephanie Spencer, Physio
Study Director
St. Clare's Mercy Hospital, St. John's
Peter Zuberbuhler, MD
Study Director
University of Alberta Hospitals, Edmonton
Suzanne Bergsten, Physio
Study Director
University of Alberta Hospitals, Edmonton
Neil Brown, MD
Study Director
University of Alberta Hospitals, Edmonton
Joyce Sharum, Physio
Study Director
University of Alberta Hospitals, Edmonton
Jacques-Edouard Marcotte, MD
Study Director
CHU Ste-Justine, Montreal
Nadia Marquis, Physio
Study Director
CHU Ste-Justine, Montreal
Patrick Daigneault, MD
Study Director
CHUQ, Universite Laval, Quebec
Christine Bouchard, Physio
Study Director
CHUL, Universite Laval, Quebec
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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