7th Pulmonary Dept, Athens Chest Hospital
Athens, Mesogion Ave. 152, Athens 11527, Greece
NCT Number: NCT01855659
Peak Inspiratory Flow Rate (PIFR) is defined by the fastest flow rate noted during the inspiratory cycle.
Inhaled medication plays an important role in the treatment of chronic obstructive pulmonary disease (COPD), with dry powder inhalers (DPIs) increasingly replacing metered dose inhalers (MDIs). DPIs are interesting as they do not require the need for coordinate actuation of the MDI device with inhalation or the use of a large spacer device 1-3. Several DPIs are available for the administration of inhaled corticosteroids, as well as bronchodilators, with each of them corresponding to a different type of inhaler (e.g. Diskus®, Turbuhaler®, Aeroliser®, etc.). During the inspiratory effort the patient generates a pressure drop with a consequent airflow across the DPI. This inspiratory flow has to be high enough to disaggregate and adequately disperse the drug powder into an aerosol cloud of drug particles and to guarantee an optimal deposition of the medication in the lung. Such peak inspiratory flows (PIFs) are not only dependent on a patient's inhalation effort but also on the internal resistance of the device.
It has been shown that optimal deposition of medication with DPIs is not achieved in some patients with low inspiratory flow rates, such as children or patients with COPD, especially during acute exacerbations. In such conditions the use of a DPI with low internal resistance has been suggested, ensuring an optimal deposition despite the lower flow rate. In addition, many clinicians are nowadays confronted with an important number of COPD patients who are aged >70 yrs
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All sexes
Observational
Athens, Mesogion Ave. 152, Athens 11527, Greece
This study will assess the inspiratory flow rates at high levels of resistance in different stages of COPD patients. PIF will be measured by in-check method.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
All In-Check Oral meters are calibrated using an ATS pulmonary waveform generator, and the product complies with the Australian and New Zealand standards for back pressure in flow meters. As with any inhalation device checking for loose foreign objects is important. The transparent body of the In-Check Oral meter is designed to allow a visual inspection before use. The meter is manufactured from medical grade components, and is suitable for multiple patient uses when cleaned appropriately between patients. The expected life of the In-Check Oral, in normal use, is two years.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
All In-Check Oral meters are calibrated using an ATS pulmonary waveform generator, and the product complies with the Australian and New Zealand standards for back pressure in flow meters. As with any inhalation device checking for loose foreign objects is important. The transparent body of the In-Check Oral meter is designed to allow a visual inspection before use. The meter is manufactured from medical grade components, and is suitable for multiple patient use when cleaned appropriately between patients. The expected life of the In-Check Oral, in normal use, is two years.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 0 (baseline)
Values of PIF measurement in COPD stages' subgroups
Time frame: 0 (baseline)
Values of PIF measurement in COPD patients per age and gender
Elpen Pharmaceutical Co. Inc.
Industry
Acronym: INSPIRE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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