Trial record 16 of 550 for:
"Cystic fibrosis"
Airway Secretion Clearance in Cystic Fibrosis
This study has been terminated.
(High dropout, problems recruiting, and smaller than expected decline in FEV1.)
Sponsor:
University of Colorado, Denver
Collaborators:
Cystic Fibrosis Foundation
American Biosystems (currently Hill-Rom)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00839644
First received: February 5, 2009
Last updated: October 1, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to compare the effect of three airway secretion clearance techniques (chest physical therapy, flutter device and high frequency chest wall oscillation) on decline in pulmonary function over a three year period in patients with cystic fibrosis.
| Condition | Intervention |
|---|---|
|
Cystic Fibrosis |
Device: High frequency chest wall oscillation Device: Oscillatory Positive Expiratory Pressure Other: PD&P: Postural drainage and percussion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Airway Secretion Clearance in 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 Colorado, Denver:
Primary Outcome Measures:
- rate of forced expiratory volume in 1 second (FEV1) decline [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- use of other pulmonary therapies [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- adherence to therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- patient satisfaction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- health-related quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 166 |
| Study Start Date: | December 1999 |
| Study Completion Date: | June 2003 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2 |
Device: Oscillatory Positive Expiratory Pressure
Therapy was prescribed twice daily for 20 minute sessions and included airway vibration, oscillating PEP, and forced expiratory technique (FET) with coughing.
Other Name: Flutter Device (Scandipharm, Birmingham, AL)
|
| Active Comparator: 3 |
Other: PD&P: Postural drainage and percussion
Each of the six positions are to be clapped or vibrated for 4 minutes. After each position the patient is to do three forced expiratory techniques (FET) and cough, continue with FET and coughing until all mobilized mucus has been cleared.
Other Name: CPT
|
| Active Comparator: 1 |
Device: High frequency chest wall oscillation
Therapy prescribed twce daily for twenty minute sessions. High frequency chest wall oscillation (HFCWO) applies sharp compression pulses via an air-pulse generator and inflatable vest. HFCWO generates transient increases in airflow at low lung volumes, cough-like shear forces, and alterations in the consistency of secretions.
Other Name: Vest
|
Detailed Description:
Study Design: Randomized clinical trial with pulmonary function testing obtained every three months in each of the three treatment groups. Change in slope of FEV1 will be compared. Days of hospitalization and use of oral or IV antibiotics for respiratory tract infection, quality of life, subject satisfaction, and compliance will also be compared.
Sample Size: Enrollment will be completed after 180 subjects have been recruited. Fifteen CF centers will participate.
Subject Selection: Subjects must have the diagnosis of CF, be > 7 years of age and have an FEV1 > 45% of predicted.
Prescribed Therapy: Each subject will receive airway secretion clearance twice a day.
Outcomes: Change in slope of FEV1; days of hospitalization and use of oral or IV antibiotics for respiratory tract infection; quality of life; subject satisfaction; compliance.
Eligibility| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A proven diagnosis of CF as evidenced by a positive sweat test (as documented by a sweat chloride >60 mEq/L by quantitative pilocarpine iontophoresis), or by the presence of two known CF mutations.
- Aged 7 or older.
- FEV1 >45% (Knudson).
- Able to perform reproducible maneuvers for spirometry at screening as defined by the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines.
- Willing to participate in and comply with the study procedures, and willingness of a parent or legally authorized representative to provide written informed consent.
Exclusion Criteria:
- Hospitalization for complications of CF, or a respiratory exacerbation resulting in - treatment with IV antibiotics within 60 days prior to screening.
- Use of any investigational drug or device within 60 days prior to screening.
- An episode of gross hemoptysis (>249 ml) within 60 days prior to screening, or during the course of the study.
- A pneumothorax in the six months preceding the study or during the course of the study.
- Patients who are pregnant or become pregnant.
- Patients colonized with Burkholderia cepacia.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839644
Locations
| United States, Colorado | |
| University of Colorado Denver and The Children's Hospital | |
| Denver, Colorado, United States, 80045 | |
Sponsors and Collaborators
University of Colorado, Denver
Cystic Fibrosis Foundation
American Biosystems (currently Hill-Rom)
Investigators
| Principal Investigator: | Frank J Accurso, MD | University of Colorado, Denver |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00839644 History of Changes |
| Other Study ID Numbers: | 06-0609, ACCURS98A0 |
| Study First Received: | February 5, 2009 |
| Last Updated: | October 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
cystic fibrosis Chest Wall Oscillation drainage, postural Medication Adherence patient dropouts |
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 June 17, 2013