Cystic FibrosisNCT00839644
Airway Secretion Clearance in Cystic Fibrosis
A study testing High frequency chest wall oscillation, Oscillatory Positive Expiratory Pressure and PD&P: Postural drainage and percussion in people with Cystic Fibrosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- High frequency chest wall oscillation, Oscillatory Positive Expiratory Pressure and PD&P: Postural drainage and percussion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Jun 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver and The Children's Hospital
Denver, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- High frequency chest wall oscillation, Oscillatory Positive Expiratory Pressure, PD&P: Postural drainage and percussion
- Keywords
- cystic fibrosis, Chest Wall Oscillation, drainage, postural, Medication Adherence, patient dropouts
- Medical subject headings
- Cystic Fibrosis, Medication Adherence, Patient Dropouts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency chest wall oscillationDevice
Also called Vest
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.
Oscillatory Positive Expiratory PressureDevice
Also called Flutter Device (Scandipharm, Birmingham, AL)
Therapy was prescribed twice daily for 20 minute sessions and included airway vibration, oscillating PEP, and forced expiratory technique (FET) with coughing.
PD&P: Postural drainage and percussionOther
Also called CPT
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Not described Receives: Device: Oscillatory Positive Expiratory Pressure |
| 3 | Active comparator | Not described Receives: Other: PD&P: Postural drainage and percussion |
| 1 | Active comparator | Not described Receives: Device: High frequency chest wall oscillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of forced expiratory volume in 1 second (FEV1) decline
Measured: 3 years
Secondary outcomes (5)
time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations
Measured: 3 years
use of other pulmonary therapies
Measured: 3 years
adherence to therapy
Measured: 3 years
patient satisfaction
Measured: 3 years
health-related quality of life
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startDec 1999
- Primary completionDec 2002
- Study completionJun 2003
Why it stopped: High dropout, problems recruiting, and smaller than expected decline in FEV1.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, American Biosystems (currently Hill-Rom)
- Responsible party
- Sponsor
- Investigators
- Frank J Accurso, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839644
- Sponsor's protocol ID
- 06-0609
- Other IDs
- ACCURS98A0
- Status last verified
- Oct 2012
- First submitted
- 5 Feb 2009
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Secretion Clearance in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00839644
- Acronym / sponsor ID
- 06-0609
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, Chest Wall Oscillation, drainage, postural, Medication Adherence, patient dropouts
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High dropout, problems recruiting, and smaller than expected decline in FEV1.
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, American Biosystems (currently Hill-Rom)
- Study start
- Dec 1999
- Primary completion
- Dec 2002 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Device: Oscillatory Positive Expiratory Pressure |
| 3 | Active comparator | Other: PD&P: Postural drainage and percussion |
| 1 | Active comparator | Device: High frequency chest wall oscillation |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency chest wall oscillationAlso: VestTherapy 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. | Device | 1 |
| Oscillatory Positive Expiratory PressureAlso: Flutter Device (Scandipharm, Birmingham, AL)Therapy was prescribed twice daily for 20 minute sessions and included airway vibration, oscillating PEP, and forced expiratory technique (FET) with coughing. | Device | 2 |
| PD&P: Postural drainage and percussionAlso: CPTEach 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 | 3 |
Primary outcome
rate of forced expiratory volume in 1 second (FEV1) decline
Time frame: 3 years
5 secondary outcomes
time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations
Time frame: 3 years
use of other pulmonary therapies
Time frame: 3 years
adherence to therapy
Time frame: 3 years
patient satisfaction
Time frame: 3 years
health-related quality of life
Time frame: 3 years
Results and safety
The study was stopped early (reason given: High dropout, problems recruiting, and smaller than expected decline in FEV1.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank J Accurso, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency chest wall oscillation, Oscillatory Positive Expiratory Pressure and PD&P: Postural drainage and percussion in people with Cystic Fibrosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: High dropout, problems recruiting, and smaller than expected decline in FEV1.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of forced expiratory volume in 1 second (FEV1) decline (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.