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

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.

Conditions

• Cystic Fibrosis

Interventions

OTHER

Positive Expiratory Pressure (PEP)

Physiotherapy technique for airway clearance

OTHER

High Frequency Chest Wall Oscillation (HFCWO) using InCourage Vest System

Physiotherapy technique for airway clearance.

Sponsors & Collaborators

• Canadian Cystic Fibrosis Foundation

  collaborator OTHER

• University of British Columbia

  lead OTHER

Principal Investigators

• Maggie McIlwaine, Physio · BC Children's Hospital, Vancouver

• George Davidson, MD · BC Children's Hospital, Vancouver

• Candice Bjornson, MD · Alberta Children's Hospital

• Clare Smith, Physio · Alberta Children's Hospital

• Hans Pasterkamp, MD · Children's Hospital of Winnipeg

• Linda Kraemer, Physio · Children's Hospital of Winnipeg

• Felix Ratjen, MD · The Hospital for Sick Children, Toronto

• Jennifer Agnew, Physio · The Hospital for Sick Children, Toronto

• Larry Lands, MD · Montreal Children's Hospital of the MUHC

• Nancy Alarie, Physio · Montreal Children's Hospital of the MUHC

• Pearce Wilcox, MD · St. Paul's Hospital, Vancouver

• Brigette Wilkins, Physio · St. Paul's Hospital, Vancouver

• Sherri Katz, MD · Children's Hospital of Eastern Ontario, Ottawa

• Linda Lapointe, Physio · Children's Hospital of Eastern Ontario

• Shawn Aaron, MD · The Ottawa Hospital

• Lynne Orser, Physio · The Ottawa Hospital

• Harvey Rabin, MD · Foothills Medical Centre, Calgary

• Julie Wilson, Physio · Foothills Medical Centre, Calgary

• Mary Noseworthy, MD · Janeway Children's Health & Rebab. Centre, St. John's

• Stephanie Spencer, Physio · St. Clare's Mercy Hospital, St. John's

• Peter Zuberbuhler, MD · University of Alberta Hospitals, Edmonton

• Suzanne Bergsten, Physio · University of Alberta Hospitals, Edmonton

• Neil Brown, MD · University of Alberta Hospitals, Edmonton

• Joyce Sharum, Physio · University of Alberta Hospitals, Edmonton

• Jacques-Edouard Marcotte, MD · CHU Ste-Justine, Montreal

• Nadia Marquis, Physio · CHU Ste-Justine, Montreal

• Patrick Daigneault, MD · CHUQ, Universite Laval, Quebec

• Christine Bouchard, Physio · CHUL, Universite Laval, Quebec

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2012-04-30

Completion

2012-07-31

Countries

• Canada

Study Locations