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

NCT ID: NCT00817180

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-07-31

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 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.

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 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 analysis and subject satisfaction will also be compared.

Number of subjects Enrollment will be completed after 170 subjects have been recruited, approximately 85 in each arm.

Number of sites The study will involve between 14 CF centres in Canada.

PERSCRIBED AIRWAY CLEARANCE TECHNIQUE The test airway clearance technique is the

• High Frequency Chest Wall Oscillation using the InCourage Vest System. This will be compared to
• The Positive Expiratory Pressure Mask Technique. Subjects will be randomized to perform one of these techniques as their airway clearance technique for the period of the study.

PRIMARY ENDPOINT Primary: Difference in the number of respiratory exacerbations. (For definition see Appendix A). Defined by the presence of one major criteria or 2 minor signs or symptoms.

Major Criteria:

• Decrease in FEV1 of ≥10% from best baseline within past 6 months, unresponsive to ventolin.
• Oxygen saturation <90% on room air or ≥ 5% decline from previous baseline.
• New finding(s) on chest radiograph.
• Hemoptysis (more than streaks on more than one occasion in past week).

Minor Signs/symptoms:

• Increased work of breathing or respiratory rate.
• New or increased adventitial sounds on lung exam.
• Weight loss ≥ 5% of body weight or decrease across one major percentile in weight percentile for age within the past 6 months.
• Increased cough.
• Decreased exercise tolerance or level of activity.
• Increased chest congestion or change in sputum.

For minor signs/symptoms, duration of symptoms need to be ≥ 5 days or significant symptom severity.

SECONDARY ENDPOINTS

Secondary:

• The time to the first respiratory exacerbation will be measured in each group using the same definition of a respiratory exacerbation as used for the primary outcome.
• Change in FEV1 measured as difference in the yearly mean rate of decline (Appendix E).
• Cost analysis between the two groups.
• Quality of life questionnaire.
• Patient satisfaction questionnaire.
• Adherence to treatment.

DATA SAFETY MONITORING COMMITTEE

The study will be monitored by a Data Safety Monitoring committee (DSMC). The will communicate regularly either by teleconference, email or by face to face meetings, to deal with issues that arise. The will review all serious adverse events as they occur. The DSMC may request an analysis at any time. At the end of the randomized trial, a report of select final analyses will be provided the DSMC. The study may be terminated if the investigators, medical monitor, or DSMC have significant concerns about the safety of HFCWO based on serious adverse events, other safety data or the conduct of the trial.

STATISTICS Primary Analysis: The number of exacerbations during treatment will be determined in each arm and the difference between the groups calculated with 95% confidence limits as a measure of precision.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Positive Expiratory Pressure (PEP) - an airway clearance technique

Group Type: ACTIVE_COMPARATOR

Positive Expiratory Pressure (PEP)

Intervention Type: OTHER

Physiotherapy technique for airway clearance

B

High Frequency Chest Wall Oscillation (HFCWO) also known as the 'Vest technique' - an airway clearance technique.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Physiotherapy technique for airway clearance.

Interventions

Positive Expiratory Pressure (PEP)

Physiotherapy technique for airway clearance

Intervention Type: OTHER

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

Physiotherapy technique for airway clearance.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maggie McIlwaine, Physio

Role: PRINCIPAL_INVESTIGATOR

BC Children's Hospital, Vancouver

George Davidson, MD

Role: STUDY_DIRECTOR

BC Children's Hospital, Vancouver

Candice Bjornson, MD

Role: STUDY_DIRECTOR

Alberta Children's Hospital

Clare Smith, Physio

Role: STUDY_DIRECTOR

Alberta Children's Hospital

Hans Pasterkamp, MD

Role: STUDY_DIRECTOR

Children's Hospital of Winnipeg

Linda Kraemer, Physio

Role: STUDY_DIRECTOR

Children's Hospital of Winnipeg

Felix Ratjen, MD

Role: STUDY_DIRECTOR

The Hospital for Sick Children, Toronto

Jennifer Agnew, Physio

Role: STUDY_DIRECTOR

The Hospital for Sick Children, Toronto

Larry Lands, MD

Role: STUDY_DIRECTOR

Montreal Children's Hospital of the MUHC

Nancy Alarie, Physio

Role: STUDY_DIRECTOR

Montreal Children's Hospital of the MUHC

Pearce Wilcox, MD

Role: STUDY_DIRECTOR

St. Paul's Hospital, Vancouver

Brigette Wilkins, Physio

Role: STUDY_DIRECTOR

St. Paul's Hospital, Vancouver

Sherri Katz, MD

Role: STUDY_DIRECTOR

Children's Hospital of Eastern Ontario, Ottawa

Linda Lapointe, Physio

Role: STUDY_DIRECTOR

Children's Hospital of Eastern Ontario

Shawn Aaron, MD

Role: STUDY_DIRECTOR

The Ottawa Hospital

Lynne Orser, Physio

Role: STUDY_DIRECTOR

The Ottawa Hospital

Harvey Rabin, MD

Role: STUDY_DIRECTOR

Foothills Medical Centre, Calgary

Julie Wilson, Physio

Role: STUDY_DIRECTOR

Foothills Medical Centre, Calgary

Mary Noseworthy, MD

Role: STUDY_DIRECTOR

Janeway Children's Health & Rebab. Centre, St. John's

Stephanie Spencer, Physio

Role: STUDY_DIRECTOR

St. Clare's Mercy Hospital, St. John's

Peter Zuberbuhler, MD

Role: STUDY_DIRECTOR

University of Alberta Hospitals, Edmonton

Suzanne Bergsten, Physio

Role: STUDY_DIRECTOR

University of Alberta Hospitals, Edmonton

Neil Brown, MD

Role: STUDY_DIRECTOR

University of Alberta Hospitals, Edmonton

Joyce Sharum, Physio

Role: STUDY_DIRECTOR

University of Alberta Hospitals, Edmonton

Jacques-Edouard Marcotte, MD

Role: STUDY_DIRECTOR

CHU Ste-Justine, Montreal

Nadia Marquis, Physio

Role: STUDY_DIRECTOR

CHU Ste-Justine, Montreal

Patrick Daigneault, MD

Role: STUDY_DIRECTOR

CHUQ, Universite Laval, Quebec

Christine Bouchard, Physio

Role: STUDY_DIRECTOR

CHUL, Universite Laval, Quebec

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Alberta Children's Hospital

Edmonton, Alberta, Canada

University of Alberta Hospitals

Edmonton, Alberta, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Children's Hospital of Winnipeg

Winnipeg, Manitoba, Canada

St. Clare's Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Ottawa General Hospital

Ottawa, Ontario, Canada

The Hospital for Sick Children, Toronto

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

CHU Ste-Justine

Montreal, Quebec, Canada

Centre Mere-Enfant du CHUQ

Québec, Quebec, Canada

Countries

Canada

References

McIlwaine MP, Alarie N, Davidson GF, Lands LC, Ratjen F, Milner R, Owen B, Agnew JL. Long-term multicentre randomised controlled study of high frequency chest wall oscillation versus positive expiratory pressure mask in cystic fibrosis. Thorax. 2013 Aug;68(8):746-51. doi: 10.1136/thoraxjnl-2012-202915. Epub 2013 Feb 13.

Reference Type: DERIVED

PMID: 23407019 (View on PubMed)

Related Links

http://thorax.bmj.com/content/68/8/746.full?sid=cc2c4e5b-3f7c-4edc-9861-b2277ff181bf

Related Info

Other Identifiers

CW08-0128

Identifier Type: -

Identifier Source: secondary_id

H07-03181

Identifier Type: -

Identifier Source: org_study_id