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

NCT03377920 | Unknown DMC

• 1 other identifier: 143201733083
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Asthma; COPD

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Severe asthma patients; COPD patients

EXPERIMENTAL

Cross sectional study Lung function measurement

Device: In-check Dial device (Clement Clarke International Ltd, Harlow, UK)

Interventions

In-check Dial device (Clement Clarke International Ltd, Harlow, UK) DEVICE

* 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

Severe asthma patients; COPD patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe asthmatics (M/F; \> 20 y) entering the Belgian Severe Asthma Registry (BSAR)
• COPD patients (GOLD stage II-IV; M/F; \> 40 y)

You may not qualify if:

• Inability to perform spirometry

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shane Hanon

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shane Hanon

CONTACT

00324776841; shane.hanon@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: December 19, 2017
• Study Start: October 12, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)