Status:
COMPLETED
Long-term Study, Comparing Vest Therapy to Positive Expiratory Pressure (PEP) Therapy in the Treatment of Cystic Fibrosis
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE2
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 c...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00817180
Start Date
October 1 2008
End Date
July 1 2012
Last Update
March 17 2014
Active Locations (13)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
Alberta Children's Hospital
Edmonton, Alberta, Canada, T3B 2C8
3
University of Alberta Hospitals
Edmonton, Alberta, Canada, T6G 2B7
4
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4