Predictive Value of Spirometric PIF to Produce PIF Rate Needed for the Use of Current DPI's.

COPD Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03377920
• Other study ID #: 143201733083
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2017
• Last updated: December 13, 2017
• Start date: October 12, 2017
• Est. completion date: September 2019

Study information

• Verified date: October 2017
• Source: Universitair Ziekenhuis Brussel
• Contact: Shane Hanon
• Phone: 00324776841
• Email: shane.hanon[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Severe Asthma

Intervention

Device:
• In-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

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PIFspiro	PIFspiro (L/s): PIF measurement from standardized spirometry (3 flow-volume measurements);	At inclusion (D0)
Primary	PIFresist	PIFresist (L/min): PIF from In-check Dial (5 flow measurements with flow restrictor in 5 different positions)	At inclusion (D0)