Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nicolaas J Smit PhD
Age
30–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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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You may not be if
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.
