View Clinical Trial (Medical Research Study)
A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease.
| City: |
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Buffalo |
| State: |
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New York |
| Zip Code: |
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14215 |
| Conditions: |
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COPD |
| Purpose: |
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This is a 26 week randomized controlled study. The study consists of, in order, an
enrollment visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There
will also be telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve
comprehensive assessments of the patients lung condition, including post-bronchodilator
spirometry, Shuttle walk distance, BODE index, health status (SGRQ) and symptoms (CCQ).
Sputum and serum samples will also be collected at these visits for microbiological and
inflammation analysis. Sputum will be obtained with the Lung Flute as an induction device
and Pulse Oximetry will be assessed prior to and after use of the Lung Flute. Clinic and
telephonic visits will collect information regarding compliance with the use of the Lung
Flute, adverse events and exacerbation history.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Male or female subjects between and including the ages of 30 and 80 years. Females
of childbearing potential may be included provided they are not pregnant or are not
nursing.
2. Subjects with a diagnosis of moderate to very severe chronic obstructive pulmonary
disease as defined by the Global Initiative for COPD (GOLD, 2008 update) and who meet
the following criteria for stage ll - IV disease:
a) Subjects must have a post-bronchodilator FEV1/FEV ratio <70% and FEV1 of <80% of
the predicted value for age, height, and sex using the NHANES III standards
(Hankinson, 1999).
3. Subjects must have a smoking history of at least 10 pack-years.
4. Subjects must have stable disease for at least 1 month prior to enrollment with no
changes in the maintenance treatment for COPD in this period.
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Exclusion Criteria:
1. History of an exacerbation or other significant disease instability during the month
preceding enrollment.
2. A primary diagnosis of asthma or bronchiectasis.
3. Inability to vibrate the reed of the Lung Flute® consistently because of severely
expiratory flow rate.
4. Subject with any evidence of significant concomitant clinical disease that, in the
opinion of the investigator, could interfere with the conduct of the study or safety
of the subject.
5. Pregnant or nursing females or females intending to become pregnant during the course
of the study.
6. Use of any investigational drug within one month or 6 half-lives (which-ever is
greater) of the enrollment visit.
7. Inability to comprehend or willingness to follow the study requirements including
attendance at out-patient clinic visit and participation in testing as called for by
the protocol.
8. Patients currently using the Lung Flute. -
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| NCT ID: |
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NCT01186822 |
| Primary Contact: |
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Principal Investigator
Sanjay Sethi, MD
VA WNY Healthcare System
Pamela Anderson, RN BSN
Phone: 716-862-8944
Email: pka2@buffalo.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Buffalo, New York 14215
United States
Anderson
Phone: 716-862-8944
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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