Long-term Study, Comparing Vest Therapy to Positive Expiratory Pressure (PEP) Therapy in the Treatment of Cystic Fibrosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis	Other: Positive Expiratory Pressure (PEP) Other: High Frequency Chest Wall Oscillation (HFCWO) using InCourage Vest System	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Difference in the number of respiratory exacerbations during the 1 year study period [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	1707
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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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Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817180

Locations

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

Sponsors and Collaborators

University of British Columbia

Canadian Cystic Fibrosis Foundation

Investigators

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
Study Director:	Nancy Alarie, Physio	Montreal Children's Hospital
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

More Information

No publications provided

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00817180 History of Changes
Other Study ID Numbers:	H07-03181, CW08-0128
Study First Received:	January 2, 2009
Last Updated:	April 23, 2012
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

physiotherapy
airway clearance techniques
Positive Expiratory Pressure Technique
high frequency Chest Wall Oscillation
vest

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases

Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013