Predictive Value of Spirometric PIF to Produce PIF Rate Needed for the Use of Current DPI's.
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|ClinicalTrials.gov Identifier: NCT03377920|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Severe Asthma COPD||Device: In-check Dial device (Clement Clarke International Ltd, Harlow, UK)||Not Applicable|
The correct use of dry powder inhalers (DPI) crucially depends on the peak inspiratory flow (PIF) that the patient can generate when overcoming internal resistance of the inhaler device.
It has been shown that some patients cannot achieve sufficient peak inspiratory flows with some DPI's, especially in the elderly population. The In-check Dial device (Clement Clarke International Ltd, Harlow, UK) allows to measure these inspiratory flows for different pre-set resistances, representing different DPI's.
Study design: interventional, single center, single visit study
30 Severe asthmatics and 70 COPD patients will be recruited in the UZ Brussel respiratory outpatient clinic.
All participants will provide written informed consent.
Patients will perform:
- pre-bronchodilator spirometry for the measurement of PIFspiro as per European respiratory Society/American Thoracic Society (ERS/ATS) guidelines for standard lung function5 (part of routine clinical follow-up).
- 5 forced inspiratory manoeuvres using the In-check Dial device G16, set at 5 different resistances (performed in order of increasing resistance), yielding the PIFresist values for the different DPI's
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Predictive Value of Peak Inspiratory Flow Rate Derived From Spirometry to Determine the Patient's Ability to Produce Peak Inspiratory Flow Rate to Overcome the Resistance of Current Dry Powders Inhalers.|
|Actual Study Start Date :||October 12, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Severe asthma patients; COPD patients
Cross sectional study Lung function measurement
Device: In-check Dial device (Clement Clarke International Ltd, Harlow, UK)
- PIFspiro [ Time Frame: At inclusion (D0) ]PIFspiro (L/s): PIF measurement from standardized spirometry (3 flow-volume measurements);
- PIFresist [ Time Frame: At inclusion (D0) ]PIFresist (L/min): PIF from In-check Dial (5 flow measurements with flow restrictor in 5 different positions)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377920
|Contact: Shane Hanonfirstname.lastname@example.org|
|Brussel, Belgium, 1090|
|Contact: Anja Baeten|
|Principal Investigator:||Shane Hanon||Universitair Ziekenhuis Brussel|