Clinical trial NCT00839644: Airway Secretion Clearance in Cystic Fibrosis
Official title: Airway Secretion Clearance in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
Chest Wall Oscillation
drainage, postural
Medication Adherence
patient dropouts
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: American Biosystems (currently Hill-Rom)
First posted: 2009-02-09
Enrollment: 166
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: rate of forced expiratory volume in 1 second (FEV1) decline
timeFrame: 3 years
Secondary outcomes:
measure: time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations
timeFrame: 3 years
measure: use of other pulmonary therapies
timeFrame: 3 years
measure: adherence to therapy
timeFrame: 3 years
measure: patient satisfaction
timeFrame: 3 years
measure: health-related quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver and The Children's Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Frank J Accurso, MD
role: PRINCIPAL_INVESTIGATOR
References: