Long-term Study, Comparing Vest Therapy to Positive Expiratory Pressure (PEP) Therapy in the Treatment of Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT00817180 |
Recruitment Status :
Completed
First Posted : January 6, 2009
Last Update Posted : March 17, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Other: Positive Expiratory Pressure (PEP) Other: High Frequency Chest Wall Oscillation (HFCWO) using InCourage Vest System | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
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. |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817180
Canada, Alberta | |
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 | |
Canada, Manitoba | |
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 | |
Canada, Ontario | |
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 | |
Canada, Quebec | |
Montreal Children's Hospital | |
Montreal, Quebec, Canada, H3H 1P3 | |
CHU Ste-Justine | |
Montreal, Quebec, Canada, H3T 1C5 | |
Canada | |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00817180 |
Other Study ID Numbers: |
H07-03181 CW08-0128 |
First Posted: | January 6, 2009 Key Record Dates |
Last Update Posted: | March 17, 2014 |
Last Verified: | March 2014 |
physiotherapy airway clearance techniques Positive Expiratory Pressure Technique high frequency Chest Wall Oscillation vest |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |