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

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.

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.

Study Overview

• Status: Unknown
• Conditions: COPD; Severe Asthma
• Intervention / Treatment: Device: In-check Dial device (Clement Clarke International Ltd, Harlow, UK)

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Anja Baeten

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Severe asthma patients; COPD patients; Cross sectional study Lung function measurement

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Shane Hanon, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 143201733083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No