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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
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Severe Asthma COPD Device: In-check Dial device (Clement Clarke International Ltd, Harlow, UK) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. PIFspiro [ Time Frame: At inclusion (D0) ]
    PIFspiro (L/s): PIF measurement from standardized spirometry (3 flow-volume measurements);

  2. PIFresist [ Time Frame: At inclusion (D0) ]
    PIFresist (L/min): PIF from In-check Dial (5 flow measurements with flow restrictor in 5 different positions)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Shane Hanon 00324776841 shane.hanon@uzbrussel.be

Locations
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Belgium
UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Anja Baeten         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Shane Hanon Universitair Ziekenhuis Brussel

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03377920     History of Changes
Other Study ID Numbers: 143201733083
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No