COPD, Severe Asthma
Conditions
Brief summary
The main aim is to study correlations between Peak inspiratory flow measured during a spirometry (PIFspiro) and Peak inspiratory flow measured over a pre-set resistance (PIFresist) in COPD patients and severe asthma patients. PIFresist will be measured using 5 different resistances, representing all DPI's relevant for the treatment of obstructive lung diseases. If this shows a distinct relationship between PIFspiro and PIFresist, PIFspiro cut-off points will be sought in an attempt to predict which patients are likely to be able to produce optimal flows for DPI use. If successful, this will make the actual measurement of PIFresist redundant in clinical practice. Also the relationship between PIFresist and device internal resistance in addition to PIFspiro (which corresponds to a very low resistance) will be examined.
Detailed description
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
Interventions
DEVICEIn-check Dial device (Clement Clarke International Ltd, Harlow, UK)
* pre-bronchodilator spirometry for the measurement of PIFspiro as per 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
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe asthmatics (M/F; \> 20 y) entering the Belgian Severe Asthma Registry (BSAR) * COPD patients (GOLD stage II-IV; M/F; \> 40 y)
Exclusion criteria
* Inability to perform spirometry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PIFspiro | At inclusion (D0) | PIFspiro (L/s): PIF measurement from standardized spirometry (3 flow-volume measurements); |
| PIFresist | At inclusion (D0) | PIFresist (L/min): PIF from In-check Dial (5 flow measurements with flow restrictor in 5 different positions) |
Countries
Belgium
Contacts
Primary ContactShane Hanon
Outcome results
None listed